Associate Manager, Regulatory Affairs (Gene Therapy)

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 reports to the Global Regulatory Liaison, Director or above, and provides support to the GRL in all aspects of regulatory affairs related to the development of novel gene therapy products including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. The main focus is expected to be on gene therapy and related technologies but could also extend to other therapeutic modalities.

Job Duties:

• Contribute to the development of regulatory strategies for gene therapy products.

• Review and approve technical documentation including validation protocols, manufacturing and labeling information, technology transfer protocols, and technical reports.

• Assist in the preparation, compilation, and organization of regulatory submissions (e.g. INDs, BLAs, MAAs, annual reports, IND amendments, BLA supplements, etc.) and ensure timely submission of above in accordance with title 21 CFR and FDA, EU and ICH guidelines.

• Critically review regulatory documents in addition to performing quality control review for accuracy, completeness, and conformance to appropriate regulations, guidelines, and SOPs

• Manage regulatory communications, including drafting of letters based on templates

• Participate in cross-functional team meetings, as required, in collaboration with, and to assist, the GRL

• Conduct research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy

Requirements:

Education

• Ph.D. in in molecular biology, chemistry, biochemistry, or related scientific field.

• M.S. may be considered on a case-by-case basis

Experience and Skills

• 2 years of pharmaceutical industry experience - relevant academic experience may be considered on a case-by-case basis

• Strong oral and written communication skills

• Ability to plan and organize effectively

• Attention to detail and follow through

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.