Manager Of Regulatory Affairs Jobs in California

Job Title: Associate Director, Regulatory Affairs Company: Gilead Sciences Location: Foster City, CA Description: This position will have broad span of influence with responsibility over Gilead’s entire development portfolio, across 4 therapeutic areas. The role will be responsible for creating the global regulatory strategy for our pipeline and will be involved in filing IND’s, CTA’s & NDA’s. This is a leadership position with high visibility and will serve as the single-point-of-contact representing CMC Regulatory Affairs in various project meetings and liaising with various regulatory agencies internationally. Essential Duties and Job Functions: Responsible for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidances are met for assigned product(s) and territories. Prepare and/or manage others’ submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs. Responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories. Responsible for ensuring preparation of the Product Company Core Data Sheets (CCDS), regulatory review of draft Product Company Core Safety Information (CCSI) and ensuring that any updates to the CCDS or CCSI are implemented in a timely manner. Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license. Acts as project team representative and may act as submission team representative for specified products. Represents Regulatory Function at internal meetings. Works proactively to build contacts with local Regulatory Authorities. Participates in industry trade groups and regulatory affairs professional societies. Maintains knowledge of highly complex regulatory requirements up to date, contribute to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management. Initiates or contributes to local and / or global process improvements which have a significant impact on the business.

Job Title: Director of Regulatory Affairs Company: Lucas Group Location: Los Angeles, CA Description: Director of Regulatory Affairs Job code: 131732 Location: CA-LOS ANGELES Job Description: Director/Associate Director Regulatory Affairs Our client prepares ready-to-file registration files for custom manufactured peptide drug substances and offers professional regulatory support to customers. We hold a number of DMFs and CEP certificates for peptide drug substances in registered pharmaceuticals. The Regulatory Director/Senior Manager will lead the RA department and supervise RA activities at our site in San Diego. The RA manager will work with the other RA site managers within the organization to implement a global RA standard. The position title will be dependent of the experience of the successful candidate. This position will be based in Los Angeles directly reporting to the Chief Operating Officer. Essential Job Responsibilities: Preparation of drug substance registration files for inclusion INDs, CEPs, DMFs and NDAs Participate in process development projects and provide regulatory guidance Responsible for RA interactions with customers and regulatory authorities Lead the RA department Oversee RA activities at the site in San Diego Required Skills/Qualifications:          Minimum BSc  degree in Chemistry or equivalent 10-15 years of professional experience in the Pharmaceutical API, or API Fine Chemical industry in areas of Regulatory, Manufacturing or Quality. At least 5 years experience in Regulatory Affairs for small molecule/chemical Drug Substance filings is required.  FDA, EMEA and bulk chemical API cGMP experience Knowledge and understanding of API chemical synthesis, Quality Control and Quality Assurance Good communication skills (oral and writing) Good leadership/ management skills IMPORTANT: Please attach your resume in Word format. Apply Here

Job Title: Regulatory Affairs Manager Company: Bio-Rad Location: Hercules, CA Description: BA/BS in Biology, Chemistry, Medical Tech. or a related field. Skills and Experience: EDUCATION: BA/BS degree in Biology, Chemistry, Medical Technology or a related field. Advanced degree is preferred, but not required. Educational background may be supplemented with coursework and certifications in the areas of FDA, QSR and ISO requirements and regulations, quality systems and principals, R&D, manufacturing, and management. EXPERIENCE: Minimum of 10 years management experience, managing Regulatory Affairs functions in IVD, device, or Pharma organizations. Direct experience with Food and Drug Administration (FDA) Regulations, Quality System Requirements (QSR) and ISO Standards, including: ' Proven experience assembling and submitting 510(k) applications. ' Sound basis of Regulatory knowledge including design controls requirements. ' Track record of successful leading inspections and audits conducted by regulatory bodies. SKILLS: Excellent and effective oral and written communication skills. Ability to collaboratively resolve conflict between individuals and groups. Solicits information, data and opinions prior to making significant decisions. Strong negotiation skills to be applied both internally and externally. Strong management skills and cross-functional management experience. Ability to ensure that the QSRs support Division as well as Business needs. Duties and Responsibilities: The Regulatory Affairs Manager reports directly to the Clinical Systems Division Regulatory/Quality Manager. Responsible for managing Regulatory Affairs, Desk Top Publishing, and Environmental Health & Safety functions, as well as associated staffs. The position provides strategic direction regarding all aspects of regulatory affairs for CSD products. This includes: 510(k) submissions International registrations Interfaces and negotiates with FDA Participates in Northern California Quality Management Review Meetings Provides RA guidance on Product Development Project Teams Being recognized as a knowledgeable resource for Regulatory advice in other departments Provides Clinical Trials strategies and direction. Interfaces with the Redmond Clinical Trials Team Assists with Research Studies

Job Title: Associate Director Regulatory Affairs - CMC Company: Location: Foster City, CA Description: Reporting to the Head of CMC Regulatory Affairs this person will responsible for leading regulatory activities for assigned projects.They will prepare submissions that are technically complex. This requires extensive interaction with departments outside of Regulatory Affairs. They will be responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned products.This person must hold a scientific degree and have at least 10 years in progressive experience in Regulatory Affairs. An advanced degree is preferred. Director people management and experience as the Regulatory representative on project teams is required. This person needs to fully understand the regulatory process and be able to suggest and support changes to the system.

Job Title: Manager Regulatory Affairs - RMD030310-25371756 Company: Location: San Francisco, CA Description: Roche Molecular Systems Inc.

Job Title: Medical Device- Regulatory Affairs Project Manager - Reg Affairs Company: CyberCoders Location: Ontario, CA Description: Medical Device- Regulatory Affairs Project Manager - Reg Affairs .body .body h4 .body .section tr.oddRow a, a:link, a:visited Medical Device- Regulatory Affairs Project Manager - Reg Affairs near Pomona, CA This job is open as of 3/20/2010. Apply Now! Not a fit for this job? Search other Medical Device Regulatory Affairs jobs! Are you an employer? Visit us for more info! Email this job to a friend - $1000 Location Pomona, CA; Ontario, CA Salary $90,000 - $120,000 Education Bachelor of Science Category QA, Quality Control Experience Required At least 2 Years Short Description Medical Device- Regulatory Affairs Project Manager - Reg Affairs Required Skills Regulatory Affairs Project Manager, Reg Affairs, Medical Device, Device Regulatory Affairs, 510K, PMA, Submissions, Quality Assurance, Class III Medical Device, FDA, Recruiter Erin Beagle Date Updated 3/20/2010 Skills Required Regulatory Affairs Project Manager, Reg Affairs, Medical Device, Device Regulatory Affairs, 510K, PMA, Submissions, Quality Assurance, Class III Medical Device, FDA, Job Description Medical Device- Regulatory Affairs Project Manager - Device Regulatory Affairs Associate/Sr AssociateIf you are a Medical Device experienced Regulatory Affairs Associate, Sr Associate or Manager, with PMA, IDE and 510K submission experience, please read on!What you need for this position:-A BS degree in Engineering, Biological Science or Physical Science is required-MS or advanced preferred-5 years + experience working in the Pharma/Medical Device Industry-5 years of experience in Regulatory affairs or Quality Assurance with Medical Devices-501k, PMA and IDE submissions experienceWhat you'll be doing:-Developing 510k, IDE and PMA submissions for Class II and III medical devices-Liasing with FDA reviewers in regards to the submission-Providing education and information to product development team, marketing, and clinical professionals -Travel about 10-15% domestic and internationalWhat's in it for you:-Excellent compensation package includes base + bonus + stock options etc-Excellent work environment-Working for a recognized industry leader in the medical device fieldSo, if you are a Medical Device experienced Regulatory Affairs Associate, Sr Associate or Manager, with PMA, IDE, and 510K submission experience, please apply today!Must be authorized to work in the United States on a full-time basis for any employer. Are you a fit for this position? Please Click Here to Apply! (your information will be kept strictly confidential!) Not a fit for this position? Click Here to Search Other CyberCoders Jobs! Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, or you may also: Email your resume in Word to: Register to View **Please do NOT change the email subject line in any way. You must keep the JobID: CC HotJobAp : EB-RegulatoryAffairsManager -- in the email subject line for your application to be considered.*** Erin Beagle - Executive Recruiter - CyberCoders Other Jobs

Job Title: Director of Regulatory Affairs Company: Advanced Bionics Location: Valencia, CA Description: Employer Information About Advanced Bionics Advanced Bionics® Corporation is a global leader in developing the most reliable, best performing cochlear implant devices in the world. Founded in 1993, AB is the only American company developing cutting-edge cochlear implant technology that restores hearing to the deaf and allows our recipients to hear their best today, tomorrow, and always. We support patients, clinicians, and physicians through the latest scientific research, technology development, educational resources, attentive customer ....more info View all our jobs Job A. Primary Function Manage the regulatory affairs function. Generate or direct regulatory affairs specialists in the preparation of submissions to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide B. Duties and Responsibilities 1. Generate or direct regulatory affairs staff in the preparation of submissions (i.e. PMA, 510(k), CE marking applications, production registrations, etc.) to obtain various worldwide approvals to commercially distribute products. Product subsequent submissions (annual reports, PMA Supplements, change notifications, etc.) to facilitate the maintenance of these approvals. Oversee the subsequent submissions (annual reports, change notifications, etc.) to facilitate the maintenance of these approvals. 2. In conjunction with Clinical Research, prepare or direct regulatory affairs staff in the generation of applications (i.e. IDE) for conducting clinical investigations in U.S., Canada, and EU countries. Generate required submissions (progress reports, etc.) to support the continuation of clinical studies. Oversee the required submissions (progress reports, etc.) to support the continuation of clinical studies 3. Responsible for issue/complaint handling system. Ensure that all reports and information required by complaint reporting and postmarket vigilance systems are maintained and submitted. 4. Provide input to the engineering teams to assure that worldwide regulatory requirements and standards are incorporated in the product development design. 5. Participate or direct the staff in the engineering change order process, by reviewing engineering and manufacturing document release and changes.: PQRB, PIR/Field Action, RLT, CAPA, Change Board, Management Review, and Risk Management. Assess and initiate regulatory filings where needed. 6. Review and provide input to labeling and marketing programs in reference to regulatory requirements. 7. Keep abreast of new or developments in various regulations and advice senior management as necessary. 8. Interface with regulatory agency representatives as needed to accomplish the above tasks. 9. Other duties as assigned. NOTES: Local Country Candidates Only. Additional Salary Information: Salary commensurate with experience.

Job Title: Director of Regulatory Affairs Company: Illumina Location: San Diego, CA Description: APPLICATIONS SYSTEMS SERVICES SCIENCE SUPPORT COMPANY Careers / Job Detail Register to View Requisition #: 1968 Posting Job Title: Director of Regulatory Affairs Department: Quality Assurance Dept Group: Quality Location: HQ Country: United States State: California City: San Diego Job Summary: This position is responsible for developing and implementing a regulatory framework to support Illumina’s entry into Diagnostics, while avoiding the imposition of unnecessary burdens on its core RUO business. This is a strategic role where the incumbent must act as a change agent to bring about an understanding and appreciation of the requirements and processes essential for the successful entry into and management of business activities in regulated markets The incumbent will have full responsibility for the management of resources allocated to regulatory activities, and will ensure that they perform as responsible partners with all other functions to achieve the business objectives of the Illumina organization. KEY TASKS AND RESPONSIBILITIES Provide global leadership for the regulatory function including product registration and compliance for all diagnostic products and services developed, manufactured, marketed, distributed and supplied by Illumina, worldwide. Ensure that the regulatory requirements impacting new products and related processes are identified and addressed during the design and development stages. Determine the regulatory impact of changes to products and processes and provide guidance for the implementation of such changes in a manner consistent with the protection of regulatory clearance or approval of affected products. Assist the VP of QA/RA in the formulation and implementation of company strategy for Premarket Notifications (510(k)’s, PMA’s, etc.) adapting to the evolution of regulatory trends. Interact with personnel at all levels in other departments to ensure full compliance with all applicable rules and regulations including those from FDA, ISO, and other regulatory agencies worldwide. Manage international and domestic regulatory submissions to achieve clearance and approval times better than known industry averages. Interact effectively with regulatory agency personnel to represent and safeguard Illumina’s interests and support the achievement of Illumina’s business objectives Ensure that all product literature such as labeling, website communications, ad/promo pieces, press releases, etc. accurately reflect the status of Illumina products, and are in compliance with regulatory requirements, providing regulatory guidance as needed to other functions involved such as R&D, QA, Marketing and Sales, Legal, etc. Implement and manage a system to maintain, retrieve and update in a timely manner key regulatory information related to facility registration, device listing, audit reports, etc. at both Federal, State, and international levels. Read, analyze, and interpret technical reports and business documents, professional journals, technical procedures, or governmental regulations to distill that information and effectively communicate it to all members of the organization who need to know it and who could be impacted by it. Prepare reports, business correspondence, procedures and manuals. Other responsibilities as assigned. The incumbent is responsible for exhibiting professional behavior with both internal and external business associates so as to reflect positively on the company and to be consistent with the company’s policies and practices. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. EDUCATION AND EXPERIENCE Bachelor or Masters degree in a Life Science, Engineering or Chemistry curriculum. Proven experience with at least 10 years of practice interacting with regulatory agencies dealing with matters of compliance with ISO, FDA, EU and other regulations and standards. Must be detail oriented, well organized, and able to work independently and in teams. Must have excellent interpersonal skills, as well as verbal and written communication skills.

Job Title: Director Regulatory Affairs Company: Roche Molecular Systems Location: Pleasanton, CA Description: Roche Molecular Systems Inc. Direct/manage regulatory project management.Provide regulatory counsel for internal and external programs (affiliates) associated with advertising and promotion of RMD products.Manage projects to budgets and timelines and provide leadership in non clinical, clinical, or CMC areas.  Participate in review of product changes post approval.Independent reviewer of regulatory applications. Work with regulatory team to develop and implement a promotional review program.Liaison with Marketing/Regulatory/Medical/Sales and Legal (internal) for the review of advertising, promotion, abstract and scientific papers and presentations.Manage the RMS Export Control Program to ensure compliance with US and Divisional requirementsEstablish and maintain training program for the regulatory staff. B.S. degree in Pharmacy, Chemistry, Biology, Microbiology or related field; advanced degree preferred.Seven to ten years experience in the device/IVD or pharma industry.  Must have knowledge of FDA regulations in support of scientific review and advertising/promotion literature.RAC preferred.Travel approximately 10% of time  Additional Information:Travel Percentage: 25%

Job Title: Part-Time Regulatory Affairs Manager Company: Caldera Medical,inc. Location: Agoura Hills, CA Description: Employer Information About Caldera Medical,inc. Caldera Medical is a rapidly growing medical device company focused on designing, manufacturing, marketing and selling implantable grafts into the Gynecology, Urology and Urogynecology surgical markets. Caldera has been marketing implants for stress urinary incontinence since 2003. Caldera recently launched its Ascend® family of implants for pelvic floor reconstruction. Caldera also markets Desara®, which is a synthetic mesh graft for stress urinary incontinence. In addition, Caldera has a robust pipeline of new products that will be launched in the next 18 months. View all our jobs Job Caldera Medical, a growing women's health medical device company, has an immediate need for an experienced Regulatory Affairs professional with experience in FDA 510k preparation and submissions, adverse event reporting, labeling, protocol development, complaint handling, audits (both internal and key supplier), ISO 13485 compliance, and general regulatory affairs issues in the medical device industry. The successful candidate will be a key member of various product teams working in concert with engineering and quality professionals to ensure compliance with applicable regulatory requirements. NOTES: Local Country Candidates Only