Regulatory Affairs Director

  •  

Seattle, WA

Industry: Business Services

  •  

8 - 10 years

Posted 46 days ago

  by    Michelle Manzon

Job Summary

Title: Regulatory Affairs Strategy - Director

Company: Pharmaceutical

Type: Permanent Role

Notes: No Corp to Corp

Responsibilities:

· Participate in design of US, EU and Canada regulatory strategies for the development of gene therapy products for rare diseases.

· Support 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

· Coordinate with the nonclinical, clinical and CMC teams' submissions

  • Manages regulatory projects and closely collaborates with Clinical, Regulatory Operations, and external vendors to coordinate and implement submission strategy and content in a global clinical biopharmaceutical development environment.


Requirements:

· BA/BS degree in life sciences. MS/PhD preferred

· 8-10 years of regulatory pharmaceutical product development experience – preferably in biotechnology, ideally in gene therapy/ATMP CNS applications; regulatory strategy and regulatory science writing

· ICH, FDA, EMA and WHO regulations/guidelines

Next Steps : Send me a quick email if you are passively or actively looking for another opportunity.Love to speak with you.

Referral Bonus: As always, we will give you a $500 referral bonus if we place someone you refer over to us! Ask for details.

Salary

$190K - $200K