Director / AD, Regulatory Affairs (NDA + Adcom) | Report to SVP of RA | Late-Phase Biotech in RTP, NC: RETAINED SEARCH
Summary: Cornerstone Search Group has been retained by a late-stage, cutting-edge biotech whose first-in-class “Fast Tracked” lead clinical candidate is in late-stage clinical development/NDA submission process for its initial life-saving Orphan indication. Based in the RTP, NC area, in this uniquely attractive and highly-visible role you will report to and work closely with the SVP, Global Head of Regulatory Affairs (who reports to the CEO), whom we know quite well, has a great personality, has a great deal of NDA and Adcom experience, and enjoys mentoring. In the near term you will be working on late-stage FDA and EMA regulatory strategy, an NDA submission, an FDA Adcom, etc. This pre-IPO company is backed by several well-known biotech venture capital companies. Given the smaller biotech environment, our client is seeking a RA professional who wants to “roll up their sleeves” and can positively collaborate cross-functionally within the organization.
Title: Director or Associate Director, Global Regulatory Affairs (title awarded will depend upon experience)
Location: Research Triangle Park, North Carolina Metro Area. Our client is seeking someone who currently lives in the area or has ties to the area.
Attractive Features about this Position and Company:
- Unique and opportune time to join: Our client is in the process of filing their first NDA. You will walk in and on “Day 1”, you will be gaining highly sought-after NDA filing, FDA Advisory Committee preparation, and MAA strategy experience that many professionals chase their entire career. This an excellent opportunity to distinguish yourself in the market and to be mentored by the hiring manager (Head of Global RA) who has led numerous NDAs and Adcoms.
- Visibility: You will work alongside the entire leadership team, getting to know and interacting meaningfully with senior/executive-level employees.
- 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 in a life-saving FDA and EU designation Orphan 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.
- Excellent Hiring Manager: We know the Hiring Manager as we helped our client hire this person. The Hiring Manager has excellent communication and leadership skills, is straight-forward, very easy and enjoyable to work for and has excellent experience (5+ NDA/MAAs and multiple Adcoms) to learn from.
- Accountable for the leadership of daily operations, strategy and oversight for all clinical/regulatory support for US FDA and EU EMA/CTA filings including: IND filings, IND yearly updates, HA meetings, NDA/MAA submissions, Adcom meetings, etc.
- Maintain the regulatory dialogue with internal teams and external vendors in support of US and EU regulatory filings and clinical development activities.
- Effectively work with cross-functional team leaders to achieve corporate and program goals.
- Advise project leadership and senior management on status of US and EU Regulatory Affairs strategies and tactics, procedures and practices.
- Direct regulatory strategies, implementation and support for development compound(s) (registration) and guide development program planning to anticipate changes in regulatory environment and approval requirements.
- Assess regulatory project plans and timelines and ensure projects are appropriately prioritized and key goals are met on time.
- Develop and maintain excellent knowledge of regulatory procedures and environments.
- Bachelor’s degree with 3-10+ years of industry experience required.
- Our client is open to hiring at the Associate Director level for a candidate on the lighter end of experience if they are a smart, passionate, hard-working RA professional that is serious about embracing this opportunity for career development by learning about FDA/EMA interaction strategy, compiling NDA/MAA submissions, and preparing for an Adcom.
- Strong understanding of regulatory authority guidance, including ICH.
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
www.cornerstonesg.com | 973.656.0220
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