Director, Regulatory Affairs
- Integrate knowledge of global regulations to provide regulatory advice to multidisciplinary teams to support clinical and nonclinical development, including preparation and maintenance of IND and CTA filings.
- Lead multidisciplinary teams in the development and authoring of major regulatory documents (e.g Meeting Briefing Packages, Breakthrough Therapy Designation Requests).
- In collaboration with the team, develop response strategies and submissions to Health Authorities
- Lead and facilitate activities, including team preparation, for meetings with FDA, EMA and other regulatory authorities.
- Author, review and provide strategic input on regulatory filing documents (e.g. eCTD Module 2 summaries, clinical protocols, Investigator’s Brochure).
- Liaison responsible for communication with FDA and other Health Authorities for assigned programs.
- Interface with partners, Contract Research Organizations and consultants as needed.
- In collaboration with team, perform/manage critical analyses of FDA and ICH guideline and independently develop strategic/tactical interpretation and implementation.
- Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks.
- Develop and implement regulatory SOPs and common work practices/strategies within the team.
- Bachelor’s degree in life sciences or related field or equivalent experience required; advanced degree and/or certifications are a plus.
- Minimum 10 years of pharmaceutical industry experience, at least 7 of which should include direct experience in Regulatory Affairs
- Extensive knowledge of GxP regulations and guidelines
- Experience with development of NCEs (in oncology preferred)
- Experience in successfully filing INDs and CTAs
- Strong organizational, problem-solving, and priority management skills
- Excellent interpersonal and communication skills (both written and oral)
- Occasional travel