Global Head (SVP/VP), Regulatory Affairs: Diverse Gx (Biosims, NCEs, etc.) – Remote Location – Build Department/Strategy: RETAINED SEARCH
Cornerstone has been Retained by growing Global Specialty Generics Pharma company that is going through substantial expansion across both NCEs and Biosimilars. Given this expansion, they are seeking a strong Regulatory Affairs leader to guide them through strategic RA development and growth, both internally and externally.
Work permanently from home and have ability to effect positive change both within the US and globally. You will have ownership across the entire internal portfolio and will report directly to the President. Our client will give the incumbent the ability to design and build the RA department and strategy as they see fit, ultimately growing a world-class RA team.
Smaller, creative environment – Our client offers a smaller, hands-on environment that rewards its people for being creative and coming up with efficient and timely strategy that ultimately leads to successful product submissions/launches.
Build the group as you see fit – This is an opportunity to leverage your experience and do things the way you believe will make the department and company most successful. Our client wants to hire someone that will come in with specific ideas and you will have the opportunity to design and grow the strategy and team as you see fit.
- Ownership of all aspects of regulatory submissions relevant to assigned projects and programs including IND, BLA, NDA, 510(k), product line extension applications and supplements.
- Build and develop a Regulatory Affairs team/department.
- Serve as the primary regulatory interface for scientific, clinical, and commercial communication, both internally and externally to ensure timely and accurate regulatory compliance.
- Lead communication with the FDA for projects across multiple therapeutic areas and lead FDA meetings and major label negotiations.
- Understand and implement US and global regulatory strategy including technical/CMC guidance relating to biosimilar and NCE products and understand the impact on current and future submissions.
- Ensure the overall regulatory strategy aligns with the target product profile (TPP), US specific development needs, and US biosimilar regulatory environment.
- Identify and assess US regulatory risks associated with product development and defines strategies to mitigate risks.
- Ensure alignment of global regulatory strategies with all key stakeholders and Senior Management.
- Develop and implement global regulatory acceleration strategies based on data and corporate goals.
- Advise key stakeholders of the effect of current or proposed laws, regulations, updated guidelines and standards related to NCEs and Biosimilars.
- Develop regulatory budget according to product development plans and keeps key stakeholders informed on project resourcing.
EDUCATION & EXPERIENCE:
- 10+ years of Pharmaceutical Industry experience to include extensive Regulatory Affairs experience across NCEs and/or Biosimilars.
- Bachelor of Science in life sciences (pharmacy, biology, chemistry, pharmacology).
- Strong understanding of Biosimilar Drug Development process from Discovery to Registration/Approval.
- Experience in IND and NDA submission of NCE, especially in Anti-Infectives, from Drug Development process to Registration/Approval is highly desirable.
Thomas Fascia | Partner
P: 973-656-0220 x717
CORNERSTONE SEARCH GROUP – Pharma & Biotech Executive Search
Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA