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Senior Director Regulatory Affairs Strategy

4 months ago

Boston, United States EPM Scientific Full time

Our client, a clinical stage biotech company, is seeking an experienced and dynamic Director of Regulatory Affairs to join their team. This exciting opportunity offers the chance for someone with clinical regulatory lead experience and Oncology experience to take on a leadership role within this rapidly growing organization.


Responsibilities:

- Lead interactions with Health Authorities and partners

- Ensure cross-functional alignment among stakeholders involved during key steps across multiple projects simultaneously

- Provide preparation of submission to global health authorities including IND, BLA, CTA, Orphan Drug Designation.

- Assist project leaders by providing guidance regarding US/EU/ROW biocompatibility requirements, testing strategy/design/etc.

-Review study protocols and clinical study reports


Qualifications:

- Bachelor's or Master’s degree in relevant field

- 10+ years’ experience working within the biopharma industry

-Understanding of Oncology Cell Therapy and Biologics

- Clinical development knowledge required