Manager Of Regulatory Affairs Jobs in California

Job Title: Sr. Director-Regulatory Affairs-Operations Company: Allergan Location: Irvine, CA Description: Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients wants and needs - and into the priorities and concerns of the medical specialists who treat them. To this end, we employ more than 50 percent of our work force in either research and development (RD) or sales, ensuring our efforts are focused on innovation and our customers.This position is responsible for directing multiple functional organizations within Allergans Regulatory and Operations. This includes Global Regulatory Support, Publishing, Business Development, Regulatory Intelligence and Information Management in support of Allergans global product portfolio. This position also independently develops, implements, maintains and manages the strategy for areas of responsibility in alignment with the global Regulatory strategy. Accountable for managing the relationships and communications with Regulatory Authorities, other Allergan Functions, and External Business Partners as necessary for the various functional areas within Global Regulatory Operations.Summary:Guide, direct, and lead a team of regulatory professionals in development and implementation of strategy for areas of responsibility. Identify risk areas and develop alternative courses of action through scenario planning and development of contingency plans.Lead the creation and maintenance of the global submission strategyInitiate and maintain appropriate communication within the RA function and represent Regulatory Affairs with relevant agencies, industry organizations, and external business units and functions.Develop and manage regulatory operations budgetAccountable for ensuring that relevant regulatory submissions meet appropriate standards including planning and implementation around emerging/changing regulatory requirements.Prioritize all business development initiatives and communicate regulatory assessments. Provide Regulatory Intel support for development projects.Additional dimensions of the role:Global responsibility for regulatory submissionsResponsible for support of Global registrationsResponsible for regulatory intel in support of development projects

Job Title: Manager, Regulatory Affairs Strategies Company: TEVA Pharmaceuticals USA Location: Irvine, CA Description: Teva Parenteral Medicines is a global leader in the manufacture of generic injectable pharmaceuticals. A member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs. The company's mission is to play a leading role in the transformation of the U.S. healthcare system through its preeminence in the development, manufacture and marketing of generic pharmaceuticals. Teva Parenteral Medicines has an excellent opportunity for Manager, Regulatory Affairs Strategies. Responsibilities: The manager, with minimal guidance, is responsible for the supervision/preparation and critical review of high quality regulatory submissions to the FDA including ANDAs, NDAs, amendments, supplements and annual reports. The manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to the Sr. Manager, Associate Director or Director. The Manager will establish regulatory strategies for submissions and manage document deliverables to assure submission targets are met while adhering to appropriate statutes, regulations and guidances. The Manager, with minimal guidance, evaluates changes and signs-off on change control documents, ensuring the correct filing category. He/She represents Regulatory Affairs on project teams and serves as team leader for projects. Working knowledge of CMC Regulatory Affairs in the generic drug industry is needed.Manages the regulatory associates in the preparation, compilation, and submission of high quality original submissions (ANDAs, NDAs, INDs), amendments, supplements, annual reports, control documents, etc. to FDA authoritiesFormulates regulatory strategy and tactics for all regulatory submissions. Evaluates changes to regulatory documents and formulates a strategy to ensure proper filing categoriesCritically reviews regulatory submissions and assigned signature discretion and authority on official Regulatory Affairs correspondenceMaintains full awareness of all regulatory activities on assigned projects and ensures that the project deadlines and performance standards for these projects are established and met.Coaches, mentors, and provides guidance to the regulatory associates.Acts as primary contact/liaison representing Regulatory Affairs with FDA, Teva business units, contract customers, and international customers as assigned.Other duties, as assigned, or as business needs require.On time submission of applications, amendments and supplements.Provides sound regulatory advice/guidance to business, research, and operations professional staff.Provides training and coaching to junior RA professional staff members.Maintain approved applications in compliance with appropriate statues, regulations, and guidances.Travel Requirements0% - 15% domestic and international, depending upon projects assigned. Qualifications: Minimum Bachelor's degree in scientific or healthcare discipline or equivalent combination of education and related experience.RAPS US RAC preferred.Minimum of 5 years pharmaceutical industry experience with at least 4 years in Regulatory Affairs.Knowledge of regulatory affairs requirements for sterile drug products preferred.Knowledge and expertise in preparation of INDs and NDAs as needed for generic drug products Prior pharmaceutical experience involving chemistry or manufacturing, especially a clear understanding of sterile drug product development process.Demonstrates a high level understanding of ICH and FDA guidelines.Demonstrates a high level understanding of product development life cycle required to support new drug and generic drug submissions.Demonstrates a high level understanding in the format and content of INDs and NDAs in CTD format.Demonstrated proficiency with computer and familiarity with electronic document management and electronic submissions.Ability to formulate regulatory strategy and tactics, e.g., legal, labeling, clinical, to support filing of a regulatory submission in the generic drug industry.Ability to influence disciplines within and outside the organization in keeping with project schedules related to deadlines for regulatory submissions on both local and global levels.Ability to envision scope of work on the near term and long term horizons and recommend appropriate load balancing.Demonstrates ability to work in a team environment, especially on virtual projects on cross cultural teams involving multiple countries and sites.Demonstrates ability to establish strong rapport with other disciplines, TEVA business units, customers, and health authority employees.Demonstrates excellent oral and written communication skills, including editing of documents by others.Demonstrates ability to communicate with health agencies on general and product specific issues in a manner acceptable to both the health agency and affected TEVA business units.Ability to influence health agencies, project teams, and/or TEVA business units to positively impact our business.Ability to manage multiple priorities effectively and work independently with minimal supervision.Demonstrates judgment in determining sufficient completeness of a submission and its acceptability for filing to a health agency.Uses appropriate regulatory judgment and discretion to benefit our business.As a member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer of generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills for our business.Teva Parenteral Medicines offers a comprehensive benefit package, including major medical, dental, vision, 401(k) and the opportunity to grow with a dynamic company. For immediate consideration, please visit www.tevausa.com. Click Employment Opportunities, then Positions Available and search for Position Req 10-5275.Resumes will be reviewed and qualified candidates will be contacted for pre-screening. Search Firm Representatives Please Read Carefully:Teva is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails.All resumes submitted by search firms to any employee at Teva via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Teva. No fee will be paid in the event the candidate is hired by Teva as a result of the referral or through other means.

Job Title: Director, Regulatory Affairs & Quality Assurance Company: XDx Location: Brisbane, CA Description: XDx is a molecular diagnostics company based in Brisbane, California, funded by Kleiner Perkins and other top tier venture capitalists. Setting the stage for a new era in personalized medicine, XDx was one of the first companies to develop and commercialize practical applications built on insights from the Human Genome Project. The company offers a method for noninvasively monitoring the immune system by measuring gene expression in a patient's peripheral blood. Our current AlloMap product is a test used to help in the management of heart transplant patients. Future applications of the XDx technology offer the potential to decrease healthcare costs and significantly improve the quality of life for patients with a variety of life-threatening or life-altering, immune-mediated diseases. AlloMap has been used in nearly 100 centers in the US, and 21,000 commercial tests have been run in our lab. Our culture is based on a belief in pioneering and innovation, integrity, people development, community, and balance in our day to day lives. The company offers excellent benefits. This is a place where you can make a difference, learn new skills, and work with outstanding people. Job Profile: The Director, RA/QA is responsible for working with all stakeholders to define and implement the company's regulatory strategy in support of CLIA, ISO, FDA submission and QSR regulations and to oversee the Quality Management System. The Quality Management System must support all company regulatory requirements and ensure the quality, safety and reliability of the company's products and compliance with industry and government standards. This position will oversee implementation of Design Control for products regulated by the FDA. In addition, the position will oversee the company's document control function. Responsibilities as follows, but not necessarily limited to: Play a leading role in defining the regulatory and quality strategy to support product commercialization Serves as the management representative for the XDx Quality System Serves (or delegates) the primary interface with regulatory bodies for non-CLIA-related operations Establish and manage a Quality Management System Drive the development, implementation and monitoring of Quality System processes, including (but not limited to) management responsibility, quality audits, personnel, design control, purchasing controls, CAPAs and complaints In close collaboration with Marketing, Sales and Research and Development, work as a business partner to review education materials, training programs, and technical documentation provided outside of the company. Play an active role with other industry Regulatory Affairs professionals and represent the company on cross-company regulatory initiatives. Create, implement, and manage a regulatory training program for employees Qualifications: BA/BS/PhD (preferred) in biological science or chemistry 7+ years Regulatory Affairs and QA experience within the in-vitro diagnostics industry Experience with post market IVDM support Experience with FDA, CLIA audits and inspections Experience working and/or leading cross functional teams Previous FDA regulatory submission experience (e.g. 510(k), PMA, PLA) Familiarity with ISO 13485 regulations Experience in a CLIA-regulated laboratory environment desirable Experience with IVD Multivariate Index Assay (IVDMIA) products desirable Experience with developing and implementing GLP and GMP Ability to network with government regulatory personnel To apply: Please email your statement of interest and resume to Register to View Please specify which position you are applying for by including the Job Code (RA-07162-HJ) in the subject line of your email. Principals only please. Only local candidates will be considered. XDx is an Equal Opportunity Employer. dered.

Job Title: Regulatory Affairs Manager, Advertising and Promotions Company: Location: San Francisco, CA Description: BioForm Medical, Inc. ? About Us Headquartered in San Mateo, CA, along with our manufacturing facility in Franksville, WI, we are a medical aesthetics company focused on developing and commercializing products that are used by physicians to enhance a patient's health and appearance. Our core product is Radiesse dermal filler, an injectable dermal filler designed to provide long-lasting, cost-effective and safe aesthetic improvement for patients. Our strategy builds upon our success with RADIESSE dermal filler by gaining a market leading position in dermal fillers, enhancing the strength of our sales and marketing organizations in the United States and Europe, obtaining additional regulatory approvals, and developing/commercializing new products beyond dermal fillers that enhance the practice of medical aesthetics. For more company information visit our website: www.bioformmedical.com Regulatory Affairs Manager, Advertising and Promotions ? San Mateo, CA Position Summary: Provides strategic direction of regulatory, policy and standards (PhRMA, AdvaMed) requirements in the development and implementation of marketing strategy and promotional programs. Works collaboratively with commercial organization to ensure promotional and advertising practices are consistent with regulatory requirements/guidelines and also supports business objectives. Proposes creative solutions to challenging promotional concepts that meet business objectives and also minimizes regulatory risk. Serves as the primary regulatory advertising and promotion reviewer for multiple product lines (pharmaceuticals and medical devices). Requires a high degree of interaction with governmental agencies and BioForm employees at all levels within the organization. Consults with Vice President, Regulatory Affairs as necessary. Essential Duties and Responsibilities ? Reviews and approves proposed advertising and promotional materials for multiple product lines (pharmaceuticals and medical devices). ? Develops and implements effective strategies for FDA (DDMAC) submissions. ? Prepares submissions of promotional materials for FDA (DDMAC) review and comment. ? Manages correspondence with FDA (DDMAC) and interpretation of advisory comments. ? Maintains a productive relationship with the FDA (DDMAC) to ensure successful and timely review of advisory submissions and effective resolution of regulatory issues. ? Functions BioForm point of contact in written and verbal communications with FDA on issues related to advertising and promotional materials. ? Maintains current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical and medical device industries. ? Ensures changes in Prescribing Information are reflected in promotional and advertising materials. Position Requirements ? BA, BS or advanced degree with an emphasis in science, health care or related fields. ? Minimum 5 years experience in the regulatory review and approval of professional and consumer prescription pharmaceutical advertising and promotion including experience with regulatory activities involved with a product launch. Medical device advertising and promotion experience desirable. ? Experience in leading activities for promotional DDMAC submissions (including pre-clearance and 2253, ?time of first use? submissions). ? Extensive experience with marketing concepts/tools, and product development process including labeling development. ? Proven ability to analyze and interpret efficacy and safety data. ? Proficient with Microsoft Office applications. We offer competitive compensation/benefits in an employee-oriented environment. To apply, send your resume and cover letter along with salary requirements to Register to View or fax to: Register to View . Candidates with experience that most closely meet our requirements will be contacted. No phone calls please. We are an Equal Opportunity Employer.

Job Title: Sr. Regulatory Affairs Manager - Medical Device Company: BioPhase Solutions Inc Location: San Diego, CA Description: BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Sr. Manager of Regulatory Affairs to work for a leading San Diego County biotechnology company. Sr. Manager of Regulatory Affairs - Medical Device Responsibilities Lead and manage Regulatory Affairs group in such areas as personnel, objectives, projects and responsibilities. Contribute to the development and implementation of business unit strategic and operating plan. Provide work direction, training and regulatory advice to direct reports and other members of the regulatory department. Interview and hire staff as necessary. Review personnel decisions to ensure harmony with overall department goals. Review submissions of less experienced regulatory staff and provide guidance as necessary to ensure continuing development of regulatory skills. Keep Senior Management informed of regulatory status of products and significant regulatory issues, and educate them about new developments. Direct submission negotiations with FDA and Notified Bodies as needed including pre-submission identification of requirements and strategy and post-submission negotiations to ensure timely approval. Maintain proficiency on regulatory requirements and develop and maintain rapport with Regulatory Agencies, group leaders and ancillary personnel. Ensure the support by regulatory staff of the international regulatory managers. Conduct annual performance reviews. Assist with setting of objectives and professional development of staff. Provide continuing regulatory education and dissemination of regulatory information to the development, marketing and clinical groups. Oversee a portion of the department budget; approve spending within defined limits. Qualifications Bachelor's Degree 7+ years of industry experience 4+ years Regulatory experience with Class III Devices Desired/Preferred Qualifications Advanced Degree Proven leadership/credibility Regulatory Agency personnel Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, All Phases of FDA Device Law/Regulations, WW Regulatory Requirements/Procedures, Project Management, Negotiations, Product/Design/ Development Systems. Proficiency in FDA compliance Demonstrated supervisory and interpersonal skills. Please contact Register to View if interested in this opportunity! Visit www.biophaseinc.com to view additional position throughout Southern California!

Job Title: International Regulatory Affairs Manager—Latin America Company: The Clorox Company Location: Pleasanton, CA Description: When you touch the lives of millions of people around the world, nothing but the best will do. That's why The Clorox Company and our subsidiaries look for people committed to work together toward common goals, while taking personal ownership for their decisions and actions. People who believe in maintaining the highest standards of business and professional conduct. People who share our values of strong competitiveness, measuring results and "doing the right thing." If you want to make your mark in millions of homes and do it where you can feel proud about it, apply now for this opportunity at Clorox: Position Summary:Individual will be primarily responsible for crafting and developing capabilities for international regulatory compliance program within the Global Stewardship & Innovation-Product Safety Environmental & Regulatory Compliance (PSERC) department. The candidate will be responsible for all of Mexico and Central America. They will set the regulatory strategy and build direct regulatory capabilities for business expansion. This will include building relationships with relevant governmental agencies and industry associations. The candidate will have complete responsibility to coordinate the product safety and regulatory aspects of the projects they work on, and the primary contact for all Mexican and Central American International subsidiaries in product regulatory compliance and safety matters. Primarily responsible for the following:Acting as Regulatory Affairs representative developing positive relationships with Mexican and Central American government agencies and the relevant industry associationsCrafting and implementing influencing strategies that enable a competitive advantage on regulatory strategies for the Latin America International Business Acting as Regulatory Affairs representative, coordinating and developing positive relationships with cross-functional teams and International government agencies.Keeping a pulse on legislation and other factors that may impact regulatory compliance and devise strategies to give the company a competitive advantage Providing overall regulatory strategy guidance on project team executions to ensure compliance on chemical inventory, product registration, etc.Coordinating and ensure robust regulatory programs are establishedReviewing Label, Marketing Communication and Product Claims for complianceCoordinating with the larger PSERC team, product supply and other parts of the organization to ensure compliance of products Establishing a consulting network and concurrence to third parties contracts and agreements Required Qualifications: At least 5 years of experience in a Regulatory Compliance Department, or relevant Mexican or Central American government agency or relevant industry association Minimal BS in Chemistry, Microbiology, Pharmacy, Foods, Biology, Biochemistry Working knowledge of Mexican and Central American regulations Broad regulatory affairs knowledge Candidate must possess strong interpersonal skills and have demonstrated ability to interact with regulators and cross-functional teams Spanish and English fluency both verbal and written skills is a must Possess strong communication skills that allow successful communication within the organization and with external agencies Experience in antimicrobial regulations is strong a plus Portuguese fluency both verbal and written skills a strong plusOther expected characteristics: Strong relationship building capabilities Ability to influence Experience working in a cross-functional environment Independence for decision making process Attention to details Resourceful Creative problem solving Initiative Must be well organized and able to handle a wide variety of tasks with ease Strong strategic thinking and execution abilities Strong process orientation Travel will be required of this position and is anticipated at 40-60% through Mexico and Central AmericaIf you are unable to fill out the online application due to a disability, please call our main # and ask for an HRrep to assist you with completing application. The Clorox Company and its subsidiaries is an EEO/Affirmative Action employer.

Job Title: Director Regulatory Affairs Company: Biosite Inc Location: San Diego, CA Description: The person in this position will lead all regulatory employees and activities for Biosite Inc. This person will be responsible for interacting with regulatory agencies, and translating regulatory requirements into a workable strategy/plan. Responsibilities will include: Setting up and operating a smoothly-running regulatory function. Evaluating, selecting, and developing regulatory personnel capable of fully functioning as a credible representative for the Regulatory Affairs function. Evaluating, selecting, and developing regulatory personnel capable of compiling scientific information, completing regulatory applications, and coordinating/managing the application and approval process. Overseeing all annual registrations and license renewals. Obtaining the earliest possible regulatory approvals for our medical technologies and devices. Providing regulatory expertise to executive management (business, scientific, and operations/manufacturing executives). Coordinating, collaborating, and participating with Quality function in all internal and external audits. Functioning as a subject-matter expert for other regulatory personnel. Qualifications: Alere San Diego is seeking a gifted regulatory leader with approximately 10 years experience leading a regulatory function in the biotechnology industry. This person must be a skilled enabler, team builder, and mentor. This person must be able to demonstrate in-depth knowledge of regulatory issues and processes affecting biotechnology in general, and diagnostic tests/devices in particular. This person must be able to demonstrate effective project management skills, and efficient multi-tasking skills. This person must know how to establish credibility with scientific experts and business leaders.

Job Title: Surgical Regulatory Affairs Manager Company: Bausch & Lomb Incorporated Location: Aliso Viejo, CA Description: The Surgical Regulatory Affairs Manager handles all regulatory development aspects surgical devices. There are 3 manager positions responsible for the following categories of product: 1) IOLs and Inserters; 2) Solutions; 3) Equipment. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities.Specific Job Duties:Responsible for developing a global product regulatory strategy for surgical devicesLiaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy developmentDevelop a product regulatory timeline aligned to Bausch & Lomb's product development, with key regulatory milestone, and activities for agency filing Coordinate with the team on the development of product labelsEnsure labeling content and product documentation is developed in accordance with regulatory requirements Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions Coordinate with key partners and regional counterparts to ensure timely and accurate submissions to Regulatory AuthoritiesAct as a regulatory contact for assigned country Regulatory Authorities for surgical devices Liaise with Bausch & Lomb country-specific surgical Regulatory Affairs personnel for international submissions and registrationsManage interactions with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections Provide regulatory guidance/input to surgical device change control and internal product review boards Manage assigned personnel

Job Title: Surgical Global Regulatory Affairs Director Company: Bausch & Lomb Incorporated Location: Aliso Viejo, CA Description: The Global Regulatory Affairs Director manages all regulatory aspects of Bausch & Lomb's Surgical products throughout their lifecycle. There are two positions, one covering Equipment, Instruments and Accessories and the other IOLs, Inserters and Solutions. The incumbent is responsible for the overarching global surgical regulatory strategy, and managing interactions with various regulatory authorities. Provides directional guidance to the business on how to prepare products for approval and keeps abreast of evolving global regulatory requirements. Leads Regulatory Affairs personnel associated with the Surgical product lifecycle (which includes but is not limited to Regulatory Product Development, Advertising and Promotion, Labeling, and evaluation of changes to product, process, facilities, etc. Leads and develops personnel to promote compliance with all laws, regulations, or guidance.Specific Job Duties:Serve as a leadership team member for Bausch & Lomb's Surgical Regulatory Affairs functionOversee the development of global product regulatory strategies for all Bausch & Lomb Surgical products Oversee the regulatory functions in relation to device design & development and product approvals, consistent with Bausch & Lomb agreed upon timelinesManage interactions with Regulatory Authorities for Surgical productsBuild relationships with regional and global Bausch & Lomb Regulatory Affairs teamsProvide regulatory support to other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections Provide regulatory guidance/input to internal product review boards Select, develop, and motivate a regulatory team that supports personal growth and a culture of compliancePlay a significant role in the performance management process and career development programs for supervised regulatory personnel

Job Title: MANAGER, REGULATORY AFFAIRS Company: Abbott Laboratories Location: Alameda, CA Description: MANAGER, REGULATORY AFFAIRS The Manager of Regulatory Affairs will provide management for various projects, to include 510(k), PMA, IDE, Pre-IDE, label/advertising/promotional review, and other regulatory compliance activities. In collaboration with the Director of Regulatory Affairs, develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets. Coordinate preparation of well-organized, complete and scientifically sound regulatory submissions. Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications. Exercise judgment within generally defined practices and departmental standard operating procedures. Accountable for budgets and schedules. Develop and maintain strong and effective relations with internal/external personnel. Travel is approximately 15-25%. MAJOR RESPONSIBILITIES: Manage Regulatory Affairs (RA) projects and or staff to ensure regulatory requirements are identified and addressed in product development teams. Keep abreast of regulatory requirements in the US and countries where Abbott Diabetes Care (ADC) intends to offer product for sale. Work with the Director of RA and/or Divisional Vice President to prepare regulatory plan/strategy for product introductions. Manage the preparation of registration documents as required for international markets. Ensure that submissions are complete, properly formatted, and comply with applicable regulatory requirements. Make certain that appropriate documentation is maintained to record regulatory decisions made in design and development activities. Provide expert advice on regulatory requirements for advertisement and promotion labeling of ADC products Additional Responsibilities: Provide input and comment on regulations and standards which may affect ADC products. Review and make recommendations on policies and procedures that impact regulatory activities. ACCOUNTABILITY / SCOPE: Train and develop RA staff Communicate project status to senior management Keep abreast of upcoming regulatory changes and the potential impact on ADC business. Perform other related duties and assignments as required. Basic Qualifications: Require a minimum of 5 years of Regulatory Affairs experience, including oversight of submissions for new products and product changes in the health care industry and at least 2 years of project management experience and managing staff. Some of the required 5 years overall RA experience can be substituted with up to 2 years in a science/technical role in the health care industry (can be within R&D, QA, Clinical or other technical function). Prefer health care industry experienced with in vitro diagnostics or medical devices. Skills: proven leadership; organizational, development skills. Needs well developed written, oral, interpersonal and negotiation skills. If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id Register to View -4675