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.
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.
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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.
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