Director/Senior Director, Regulatory Affairs

Full time position

Company Summary

Axovant Gene Therapies seeks a Director of Regulatory Affairs to contribute to the overall success of the company working to develop cures for rare and devastating CNS diseases using novel AAV gene therapy approaches. We seek an experienced Regulatory professional to manage regulatory activities associated with pipeline and late phase clinical development, working in partnership with the development R&D team and CMOs. This position reports into the head of Regulatory Affairs.

 

The candidate must be able to interpret biologic/ATMP regulations as they apply to given phases of drug development including preclinical, clinical and commercial.  This is an exciting team-building, hands-on leadership role within the Axovant team. The position will be based in the US in the New York City headquarters.   Remote candidates are also considered, preferably EST time zone.

Primary 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

  • This position requires 15%-20% international and domestic travel

Requirements
 
  • BA/BS degree in life sciences – preferably in biotechnology, chemistry and/or biology.  MS/PhD preferred but not required.

  • At least 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

 

This is an exciting time to join the field of gene therapy in general, and to become a part of Axovant Gene Therapies’ fast-growing dedicated team. Axovant Gene Therapies is a publicly traded company (NASDAQ: AXGT). We offer an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.

All interested applicants should send a cover letter and resume to: HR@axovant.com

Agencies/Recruiters

 

We maintain a list of approved professional recruiting agencies with which we have signed agreements. Candidates will be considered only when the agency has a signed agreement and Human Resources authorization to present candidates for a specified position(s). Candidates submitted outside of this process are considered unsolicited and will not be considered. Agencies interested in establishing a relationship with Axovant may send company information to careers@axovant.com. A member of the Human Resources team will contact you if we require the services your company offers.

AXOVANT GENE THERAPIES

Eleven Times Square, 33rd Floor
New York, NY 10036
United States

+1-833-AXOVANT (1-833-296-8268)

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AXOVANT SCIENCES GMBH

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4051 Basel
Switzerland