VP, Regulatory Affairs: Late-Stage, Pre-IPO Biotech filing in US & EU, Reports to CEO: RTP, NC Area: RETAINED SEARCH
Summary: Cornerstone Search Group has been retained by the CEO of a late-stage, pre-IPO company whose first-in-class, FDA “Fast Tracked” lead clinical candidate is in late-stage clinical development in the US and EU for its initial indication. In this critical and highly-visible role, you will have ownership for all Regulatory Affairs activities in the US and EU pre- and post-launch. Our client is backed by several well-known biotech venture capital companies. Given the smaller biotech environment, our client is seeking a Regulatory Affairs professional who wants to “roll up their sleeves” and can positively collaborate cross-functionally within the organization. This is an ideal time to join just before the company goes public.
Company: This well-funded, innovative, pre-IPO biotech has the backing of several highly-respected life science VC / PE firms as well as pharma company VC arms. They are focused on acute life-saving medical conditions that have high unmet need.
Title: Vice President (Global Head), Regulatory Affairs
Location: Research Triangle Park, NC area
Attractive Features about this Position and Company:
- Complete ownership of Regulatory Affairs: You will be the highest ranking Regulatory professional within the organization and will report directly to the CEO.
- Perfect Timing: Join this pre-IPO Biotech as they prepare for their first submissions in the US and EU, their subsequent commercial launch. This is an opportunity to step in and make an immediate impact on the company. Furthermore, you will receive stock ownership at the right time (i.e. just before FDA/EU filing and IPO).
- CEO that respects and values RA: You will report directly to the CEO and have the opportunity to influence regulatory strategy as such.
- Visibility: You will work alongside the executive leadership team, getting to know and interacting meaningfully with the C-level executives.
- Innovative Company: This company is focused on innovative therapeutic approaches. Their lead compound in development is a first-in-class, internally developed candidate that has gained FDA “Fast Track Status” for its initial indication.
- Small Company Culture: You will be working in a collegial, fast-paced environment where you’ll have the opportunity to put strategy and plans more quickly into motion due to their being less “red tape” than is typically found in mid-sized to larger companies.
- Serve as the senior-most Regulatory Affairs professional, leading strategic activities across all programs and actin as the primary contact for all Regulatory agency correspondence and interaction in the US and EU.
- Create and maintain Global Regulatory Plans.
- Provide guidance on, and be accountable for, all correspondence and interactions with regulatory agencies and any global regulatory submissions (e.g. NDAs, MAAs, etc.).
- Prepare and lead meetings with the FDA and EMA.
- Ensure appropriate Regulatory compliance in the conduct of external communications, development programs, Quality programs and reporting to the FDA and international regulatory agencies/authorities.
- Act as the Regulatory Lead in key cross-functional project team activities and work closely with Clinical, Non-Clinical, and CMC colleagues.
- Manage regulatory budget and resources
- Build acceptable and compliant Regulatory policies and procedures across the company, including for commercial products
- 10+ years of Regulatory Affairs experience within Pharma and/or Biotech.
- Demonstrated senior leadership experience in Regulatory Affairs.
- Proven experience with NDA preparation and submission. MAA preparation/submission experience is desired, but not required.
- Proven experience with preparing and running FDA advisory meetings. Experience with EMA interactions is desired, but not required.
- Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources.
- Regulatory experience with commercial products is desired, but not required.
- Scientific background with a MS / PharmD / PhD / MD is desired.
Cliff Miras | Co-Founder & Managing Partner
CORNERSTONE SEARCH GROUP - Life Sciences Executive Search
Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA
CH: 41 61 508 7010