Manager Of Regulatory Affairs Jobs

Job Title: Regulatory Affairs Manager Company: Location: San Diego, CA Description: Regulatory Affairs Manager Our client is one of San Diego's premier biotech companies. They are currently seeking a Regulatory Affairs Manager with experience in the IVD industry. If you have excellent oral and written communication skills, solid computer skills and 8-10 years of experience in RA, including at least 4 in IVD, this is a great opportunity for you! This position acts independently to determine methods and procedures on new or special assignments and may supervise the activities of other lower-level personnel. Major Job Responsibilities ? Participate on product development core teams as regulatory representative ? Interpret and apply regulations by creating regulatory strategies for domestic and international markets ? Prepare hardcopy and electronic information packages for submission to regulatory agencies ? Lead complex regulatory submission teams ? Provide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance ? Review validation, clinical and stability protocols and reports for regulatory submission soundness ? Assess manufacturing process and labeling changes for regulatory reporting impact ? Define, monitor and receive deliverables for submissions ? Write and/or edit submission documents using regulatory templates, or create new templates ? Participate in Material Review Board and complaint/recall meetings ? Complete health hazard assessments for regulatory reporting of product problems; prepare regulatory agency information packages ? Keep informed of new and revised regulations; disseminate information as directed by management ? Interact with regulatory agencies, maintain correspondence and other records of interaction ? Assemble paper and/or electronic copies for submission ? Prepare internal procedures for continuous process improvement ? Mentor junior members of the department ? Provide regulatory guidance and/or training to external departments and marketing partners ? Assist in hosting inspections, as needed ? Assist in conducting internal/external audits, as needed ? Manage consultants, as needed Education & Experience Typically requires a BS/BA degree or equivalent and a minimum of 8-10 years related experience OR MS degree or equivalent and 4-6 years related experience OR PhD and 3-4 years related experience. Required Skills Solid computer skills Advanced written and oral communication Experience and knowledge of IVD manufacturing

Job Title: Director of Regulatory Affairs Company: Insight Pharmaceuticals Location: Langhorne, PA Description: Headquartered in Langhorne, PA, Insight Pharmaceuticals was founded to acquire niche consumer OTC drug products from larger companies, focusing on their biggest brands. Our company's philosophy is to earn customer (retailer) loyalty and build consumer affinity by offering effective medications which target specific health needs, providing them with maximum relief of their symptoms. We have recently begun a campaign to re-establish these brands in the marketplace through focused consumer and trade marketing support. Director of Regulatory Affairs In this leadership role, we will rely on you to be responsible for the entire Regulatory Compliance of our company. You will maintain continuous improvement of Regulatory Compliance as well as manage the Drug Stability Program and establish expiry periods. Additionally, you will perform the following duties: Maintain label change management (regulatory aspect and process owner) Establish and manage quality agreements Establish portions of the expense budget Manage regulatory aspects of consumer affairs, including addressing quality issues with manufacturers and adverse event reporting Maintain regulatory registrations and annual filings Manage internal SOPs Summarize and prepare annual product reviews Review and approve change controls Maintain product documentation Review quality releases and sign off on product acceptances Manage drug listings Oversee / support Canadian registrations Support Canadian quality requirements Update MSDSs Assess impact of product changes and determine requirements Address product quality Issues Qualifications: Master's degree; PhD a plus 15-20 years work experience in a regulatory role in the pharmaceutical industry; preferably dealing with OTC/RX products Thorough knowledge of FDA Guidelines (21 CFR parts 210 and 211) and Good Manufacturing Practices (GMP's) Advanced training and certifications a plus Excellent interpersonal and communication skills Must be self directed and able to effectively prioritize with limited direction Analytical thinker with a strong business acumen Strong computer skills Benefits: We value our employees' time and efforts. Our commitment to your success is enhanced by our competitive salary, depending on experience and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture. To Apply: To respond to this opportunity, please respond to: https://administaff.ats.hrsmart.com/cgi-bin/a/highlightjob.cgi?jobid=59745 Administaff is not a staffing agency. In fact, most of our listings presented are great full-time or part-time opportunities with small- to medium-sized companies. By delivering HR services such as recruiting, payroll and training, Administaff can help its clients focus on what they do best. And because we have the inside track to these firms, you'll have a jump on your next career! EOE

Job Title: Assoc Director, Regulatory Affairs Company: Biogen Idec Inc Location: Cambridge, MA Description: This position is in the Regulatory CMC group and is focused on the development of large molecules (biologics), including both commercial and development programs. Responsibilities include actively contributing to the development and implementation of CMC regulatory strategy for specific projects including identifying and assessing regulatory risks, serving as the regulatory representative on project teams, serving as the regulatory contact with relevant regulatory authorities, and coordinating all CMC aspects of regulatory submissions.Qualifications Minimum 8+ years pharmaceutical/biotechnology industry experience, 4 years regulatory experience working on large molecule programs. Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals. Demonstrate excellent communication skills. Ability to represent the department in project teams. Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload. Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff. Experience in interfacing with relevant regulatory authorities. Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements. Knowledge and understanding of applicable regulations. Computer literate.EducationBA/BS/University degree required, Life/Health Sciences preferred

Job Title: Regulatory Affairs Manager Company: Medical Staffing Network Location: Boston, MA Description: Our client is a biopharmaceutical company focused on the discovery, development, and commercialization of novel immunotherapies designed to reprogram the immune system and provide a long-term, durable remission after a short course of therapy. They were recognized as one of Boston's outstanding employers by the Boston Business Journal.We are seeking a successful, highly motivated individual who will be responsible for the collection and filing of paper and electronic submissions to Regulatory Authorities (ex. FDA, HC, EU, etc). A major focus of this position is in support of moving company towards electronic regulatory submissions.Responsibilities for this position:- Review of document format to assure compliance with regulations and electronic standards.- Maintenance of regulatory archive for storage of final, signed off versions of submissions, saving submissions to the appropriate electronic file, and updating the associated submission tracking log (s) for US, EU, etc.- Develop and maintain proficiency in compliance with current guidance on electronic submissions.- Work with Senior Management in the development and recommendation of vendors for electronic submissions (eCTD, SPL, REMS, etc).- Develop and maintain project timelines for regulatory submissions.- Create and maintain appropriate regulatory SOPs.- Train personnel on electronic processing as appropriate.- Participate in GXP audits to assure regulatory compliance as needed.

Job Title: Manager, Regulatory Affairs Company: Ventana Medical Systems, Inc. Location: Tucson, AZ Description: Brief Posting Description: Responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Responsible for assessment of device changes for regulatory implications. Essential Functions: - Manage activities associated with regulatory approval of in vitro diagnostic medical devices. Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements. Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations. - Manage submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings. Provide regulatory support on project teams. - Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects. - Interface with regulatory authorities on regulatory and technical matters, as appropriate. - Manage the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department. - Manage in review of labeling changes, advertising and promotional activities, etc. - Act as internal consultant on regulatory issues such as recalls or field actions. - Review of proposed device changes. Requirements Formal Training/Education: B.S./B.A. in biological science or engineering field; advanced degree preferred. US Regulatory Affairs Certification preferred; EU certification preferred Experience: Experience working in a cross-functional team setting. Minimum 5 years experience in regulatory approval process in in vitro diagnostics or medical devices, or equivalent level of regulatory experience; a) Experience with Class II and Class III medical devices. b) Previous experience with regulatory submissions including IDE, 510(k), PMA submissions, experience with Class II and Class III medical devices, product development experience. Knowledge, Skills, and Abilities: - Strong organizational skills and attention to detail required. - Experience with Microsoft based applications and general knowledge of PC functions necessary. - Ability to work in a fast-paced/entrepreneurial team environment. - Results and goal oriented. - High degree of initiative with the ability to work independently - Excellent oral and written communication skills. - Ability to prepare and present information to groups. Writing sample required. - Ability to comprehend principles of engineering, physiology and medical device use. - Ability to plan and organize work while remaining flexible. - Excellent time management skills. To apply visit https://careers.ventanamed.com . Vacancy # IRC16232 Ventana is an equal opportunity employer. M/F/D/V

Job Title: Sr Mgr, Regulatory Affairs Company: Millennium Pharmaceuticals, Inc. Location: Cambridge, MA Description: Company Information:Breakthrough Careers!A career at Millennium: The Takeda Oncology with something no other can offer: a of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.Position Summary:This individual is responsible for actively contributing to the development and implementation of CMC regulatory strategy for small molecule products in development as well as coordinating all aspects of CMC regulatory submissions relevant to their assigned projects or programs. This person will serve as the regulatory CMC representative on relevant project teams, and as the regulatory CMC contact with the FDA.Duties and Responsibilities:Contribute to the development of global CMC regulatory strategy for products in development. Direct management of assigned small molecule development programs. Drive all CMC submission activities (IND, CTA, NDA, BLA) and health authority interactions (meeting requests and briefing documents). Represent Regulatory Affairs at various project team and working group meetings. Assess and CMC regulatory requirements to ensure all development activities are in with applicable regulations and guidelines. Develop and manage project timelines as well as have the ability to multi-task. Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic. Contribute to the development of equivalency protocols, validation protocols, and stability protocols. Ensure the quality and content of all submissions to health authorities. Liaise with partnering to ensure regulatory alliance. Mentor and coach junior regulatory staff and other team members.Qualifications:Basic Qualifications: Position requires a minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful. Must have a minimum of 4 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry. Previous experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with regulatory authorities is also required.Preferred Qualifications: Must demonstrate a solid working knowledge of drug development process and knowledge of US regulatory requirements; EU, Canada, and ROW experience highly desirable. Candidates must be able demonstrate strong project management, problem-solving, negotiating, interpersonal and skills (both written and oral).

Job Title: Dep Director, Regulatory Affairs Company: Sanofi Pasteur Location: Swiftwater, PA Description: Deputy Director, Regulatory Affairs (Regulatory Development)Sanofi Pasteur, Inc. is looking for an experienced Regulatory Affairs professional with expertise in global regulatory requirements pertaining to the development and registration of new biotechnology products, including monoclonal antibodies, small molecules, or gene therapy products.The Deputy Directory, Regulatory Affairs is commonly referred to as the (global) Regulatory Product Manager (gRPM/RPM) and has the lead responsibility for at least one major project or for several projects in the Regulatory Development (REG DEV) group. This position will be specifically responsible for overseeing and managing the Clinical, Non-clinical and CMC regulatory activities to support new biotechnology programs in preclinical and clinical development.Responsibilities - Responsible for the oversight and management of all regulatory activities (US and EU/ROW) to support clinical development and clinical trials - Develop effective regulatory strategies for global product development (investigational and commercial launch) - Represent regulatory on relevant strategic and operational teams (e.g., Project Teams and Regulatory and Clinical Subteams/Working Groups). Serve on due diligence assessment teams, as assigned. - Apply knowledge of key global Clinical, non-clinical and CMC guidance documents, regulations, or directives and effectively communicate any impact on SP's development programs - Interact with regulatory authorities (US FDA, EMEA, BGTD-Health Canada, other local Health Authorities, etc.) regarding Clinical, non-clinical and CMC aspects for biotechnology and/or biological product programs - Interface with manufacturing contractors and CROs, when necessary - Lead all regulatory activities to support high quality regulatory documentation (e.g., INDs, NDAs, CTAs, briefing documents, post-approval efficacy supplements, etc.) - Develop and maintain/manage timelines for the preparation of regulatory submissions - Ensure compliance with existing regulatory applications (e.g. IND/CTA maintenance) - Contribute to the development and implementation of processes and standards - Limited travel may be requiredWe are an equal opportunity employer M/F/D/V.

Job Title: Regulatory Affairs Director Company: HaloSource, Inc. Location: Bothell, WA Description: Responsible for all facets of the company's product and regulatory compliance programs. Provide regulatory leadership, strategy and guidance to executive management, technical, and business development staff. Ensures compliance with all state, federal and international regulatory statutes and laws. Maintain knowledge and understanding of all applicable international and domestic compliance regulations. Key regulatory strategy officer for the company. Duties and Responsibilities Supervise staff of 1-2 professionals. Define and implement domestic and international regulatory strategies. Work collaboratively with Executive, Business Development and Technical management to align regulatory strategy with overall business, commercial, brand and IP strategies. Oversee, review and prepare the submission of all regulatory documents with EPA and international regulatory agencies. Responsible for oversight of all aspects of regulatory submissions including data integrity and product performance claims. Support and represent Company to regulatory authorities including the EPA and other regulatory agencies, including international agencies. Advises on necessary product or market actions as required for regulatory approvals and compliance. Support new product development and existing product changes; provide guidance to product teams for regulatory pathway development, testing requirements, clarification, and follow up of submissions under review. Develop and maintain effective relationships with regulatory agencies Oversee and assist in the development and implementation of policies and procedures to facilitate communication and operational efficiency. Support and integrate work within a structured quality system. Actively collaborate with Quality management in document control, label claims and approvals, document review, etc. Develop and manage regulatory budget Oversee outside regulatory counsel and advisors both domestically and internationally. Advise Executive management on emerging regulatory issues and work closely with management on strategies to comply and benefit from emerging regulatory trends. Work creatively and collaboratively with Marketing and Sales management on key product messaging and compelling value proposition language and claims while adhering to the letter and the spirit of the regulatory laws and framework. . NOTES: US Residents Only. Additional Salary Information: DOE

Job Title: Regulatory Affairs Manager (Job #97) Company: Polaris Search Group Location: Gaithersburg, MD Description: Regulatory Affairs - Project ManagerJob DescriptionPosition Summary:Reporting to the Associate Director for Regulatory Operations Systems, this position will support [the 's] ongoing regulatory initiatives by assisting in the planning and implementation of departmental information systems required for Regulatory Operations. The role provides system analysis, business analysis, and technical support for the implementation, validation, and life cycle management of Regulatory systems/databases. The position also includes involvement in the full system development lifecycle and requires knowledge of the project implementation and management process. This will involve participation in workshops, interviewing key staff, authoring and reviewing related requirement documents, and providing support in the selection, implementation, and validation of Regulatory systems/databases.Major Duties and Responsibilities (including supervising others):Assists in the analysis and implementation of Regulatory systems/databases by:Defining and authoring user requirement specificationsParticipating in the selection of Regulatory systems/databasesAssisting in the design, build (as needed), testing, validation, and documentation processesPerforming project management activities (as needed)Tracks status of all ongoing Regulatory system projectsRecommends system improvements and coordinates implementationAssists in providing system automation needs and support for RegulatorySupports system-related initiatives in support of Regulatory submissionsActs as liaison between Regulatory and IT by:Ensuring departmental strategy integrates with enterprise-wide IT technology strategyInforming the IT department of Regulatory's IT needsEnsures validation requirements are in with FDA 21CFR Part 11 and related regulationsCreates an effective, collaborative relationship with ITInitiates new solutions to aid in the automation of Regulatory processes by being aware of advancements in scientific technologies and current Regulatory guidelines

Job Title: Regulatory Affairs Manager Company: Becton Dickinson Location: Durham, NC Description: This associate will be responsible for the management of regulatory product submissions from the strategic planning stages through conduct of clinical trials and submission to FDA and/or international regulatory agencies. Provide regulatory input on all advertising and promotional material for US and international markets.Principal Accountabilities:Manage planning and preparation for regulatory submissions (510(k), PMA Supplements, and other regulatory documentation) for product approvals to the FDA and international governmental agencies, including requisite post-market approval reports. Assure regulatory body submissions are prepared and processed in a proactive manner.Assist in the planning and design of clinical studies in support of FDA Pre Market Approvals (PMA, 510K clearances, post-market studies, and internal studies (including feasibility studies) as required.Help to oversee regulatory registrations and submissions for commercialization in US and ex-US countries.Assess engineering changes for impact to product approvals, including review and approval of engineering change requests.Assist in the development of policies and procedures which provide direction to Company on regulatory requirements in support of Product Development.Maintain proactive and positive working relationships with internal and external customers, both US and Ex-US, as assigned by the Sr. Director of Regulatory Affairs, to ensure the Company is positioned to meet strategic corporate goals.Job Dimensions:Responsible for providing regulatory input on decisions regarding product development cycles and key member of US and ex-US regulatory strategy teams.