Director/Senior Director Regulator Affairs

Proclinical is currently recruiting for a Director/Senior Director of Regulatory Affairs with a global pharmaceutical company located in New York, NY. Successful candidate will contribute to the overall success of the company working to develop cures for rare and devastating CNS diseases using novel AAV gene therapy approaches.

Job Responsibilities:

• Proactively participate in design of US, EU and Canada regulatory strategies for the development of gene therapy products for rare diseases.
• Oversee and manage preparation and submissions (including but not limited to pre-IND, IND/CTA, BLA/MAA and PIPs) of high-quality regulatory dossiers in the US and EU according to set timelines; this will require, strong regulatory knowledge and experience, cross-functional interactions, excellent project management and writing skills, and a good understanding of the underlying science.
• Collaborate with the nonclinical, clinical and CMC teams to ensure seamless integration of components in all submissions.
• Participate in interactions and negotiations with regulatory agencies to clarify and solidify strategy and resolve issues.
• Lead preparation of agency meetings and actively participate in scheduled meetings.
• Drive adherence to regulatory requirements and guidelines.
• Perform regulatory intelligence activities - monitor regulation changes and competitor trends/strategy.
• Provide regulatory input regarding budget.

Skills and Requirements:

• BA/BS degree in life sciences - preferably in biotechnology, chemistry and/or biology. MS/PhD preferred but not required.
• 8-10+ years of regulatory pharmaceutical product development experience - preferably in biotechnology, ideally in gene therapy/ATMP CNS applications.
• Well-versed in regulatory strategy and regulatory science writing.
• Knowledgeable in ICH, FDA, EMA and WHO regulations/guidelines.
• Ability to work independently and thrive in a fast-paced environment.
• Strong attention to detail and well organized and able to multi-task.
• Outstanding communication and time management skills.
• Passionate about patient-focused drug development toward finding cures for diseases with unmet need.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matthew Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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