Senior Manager Regulatory Affairs Combination Products

Regeneron Pharmaceuticals Tarrytown , NY 10591

Posted 4 weeks ago

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
Leads combination product regulatory activities, including device development activities, protocol reviews, overseeing/managing Health Authority (HA) correspondence and submissions. This role includes overseeing various outside contractors, supporting project teams and development partners and leading Health Authority activities.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Provide regulatory interpretation, position and strategy for combination products and devices requirements

  • Support device development activities from a regulatory standpoint during early phase, development, submissions and post market requirements

  • Support development of design control documentation and quality systems for combination products

  • Support combination products regulatory submissions, including obtaining HA feedback and submitting IND, CTA, BLA applications and MAA filings.

Education and Experience:

Requires Bachelors in Science, Applied Science, Engineering, Industrial Design, or similar and 10+ years' experience, Master's Degree with 8+ or PhD with 3+ years working with medical, commercial or industrial products from pharmaceutical, regulatory, design, testing, validation, ergonomics and human factor perspective. Ideal candidate will have a combination of regulatory, pharmaceutical, device design, testing, human factors and usability expertise in regulated environment.

  • Expertise with implementing device regulations is necessary

  • Strong Technical writing and oral communication skills

  • Experience with Health Authorities, V&V protocols and test reports

  • Previous experience with device regulatory requirements and development processes for combination products

  • Experience writing technical documents like test reports, technical memos, input requirements documents, human factors protocols, etc.

  • Experience preparing information for 51Ok, IDE, IP and PMA submissions is a plus

  • Human Factors and Pharmaceutical experience

  • Regulatory submissions experience

  • Understanding of global regulatory requirements for device and combination products

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media. We do not interview candidates on Google Hangouts. Any questions about job listings can be directed to candidatesupport@regeneron.com. We also do not hire for "at-home data entry" positions.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Regulatory Affairs

Regeneron Pharmaceuticals

Posted 2 months ago

VIEW JOBS 4/15/2020 12:00:00 AM 2020-07-14T00:00 Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary: This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of Regeneron's quality, preclinical, and clinical drug development programs, policies, and procedures, so that development teams are able to meet all objectives within specified timelines and the necessary state of compliance is maintained relative to all regulatory commitments/requirements. Responsibilities: * Act as liaison between company and FDA and other health authorities for assigned programs * Develop regulatory strategies for assigned programs, in order to support Regeneron's development and marketing objectives. This will be achieved through analysis of guidances and assessment of other drugs, and in collaboration with Regeneron's regulatory senior management. * Management of regulatory activities associated with Regeneron development programs. o Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals. o Provide guidance to multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application or CTA for ex-US studies. Edit or manage the editing of scientific sections of regulatory documentation against the regulatory requirements. Assist with the writing, review and preparation of an IND application. Manage the organization, preparation and review of IND amendments, annual reports and other regulatory documents and correspondence. o Perform/manage critical analyses of data (clinical, preclinical and manufacturing), independently developing interpretations and conclusions. o Perform reviews of clinical protocols and study reports to focus attention on deficient/missing items/explanations. o Accountable for ensuring the completeness and accuracy of all regulatory submissions. o Supervisory responsibility for the planning, preparation and submission of regulatory documentation. * Management of the planning, preparation and submission process for licensing applications. o Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA) or MAA and the subsequent regulatory review process. o Assist with the scientific writing and review of a BLA and evaluate conformance with the regulatory requirements. * Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required. Requirements: * Requires an advanced technical degree in life sciences * Expert knowledge of regional health authority regulations and advanced knowledge of global regulations * Demonstrated interactions with local health authorities * Excellent communication skills (verbal and written) and strong analytical skills * Demonstrated leadership and project management skills, including cross-functional communication * Education: Ph.D., PharmD, or MD * At least 5+ years of RA experience and biomedical research This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media. We do not interview candidates on Google Hangouts. Any questions about job listings can be directed to candidatesupport@regeneron.com. We also do not hire for "at-home data entry" positions. Regeneron Pharmaceuticals Tarrytown NY

Senior Manager Regulatory Affairs Combination Products

Regeneron Pharmaceuticals