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Director Combination Products, Regulatory Affairs

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, NY
Start date
Oct 3, 2019

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Job Details

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.

Responsibilities:

• 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.
Requirements:

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 submission 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.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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