Director of Global Regulatory Affairs

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About the job

Are you a director-level regulatory affairs specialist? Do you have experience developing regulatory strategies for infectious diseases vaccine products?

Invenia is pleased to have partnered with a clinical-stage vaccine development organization that is specialized in bringing new approaches to designing vaccines for diseases such as influenza. Due to their rapid expansion plans, this business is looking to hire a Director of Global Regulatory Affairs for their state-of-the-art laboratory offices based in New York. The Director of Global Regulatory Affairs will manage the vaccine development roadmap by facilitating the identification and resolution of scientific and regulatory issues with global Health Authorities such as the FDA, EMA, CDSCO.

This is a full-time, office, and home-based position reporting to the Senior Director of Regulatory Affairs.

Role responsibilities:

If successful, you will assume global regulatory lead responsibilities for relevant programs, you will function as primary contact with health authorities and lead all product life cycle management activities from early development through post-approval. You will be responsible for proactively formulating regulatory strategies that provide for streamlined development and approval timelines, collaborating closely with all other departments (nonclinical, CMC, immunology, development, clinical, and project management) on the development and implementation of the regulatory strategy for each program.

You will lead and coordinate all regulatory activities required for submissions to health authorities for assigned vaccine products, initiate and respond to health authority contacts to ensure expedient and efficient review and approval of products, and lead the creation of all regulatory documents submitted to health authorities.

What we are looking for: 

The ideal candidate will have a B.S in the sciences or health-related field, and a minimum of 10 years of regulatory strategy experience with emphasis on clinically related submissions. We are looking for an individual with knowledge of end to end vaccine development process and knowledge of US, global regulations, and specific health authority guidance documents. You should also have experience working with biological products and experience preparing IND/CTA/BLA/Type II variation submissions and briefing packages for health authority meetings.

If you are interested in proceeding with this fantastic opportunity, please apply.