VP, Global Regulatory Affairs | Public Biotech in NY/NJ area | 1st in class Biologics Platform: RETAINED SEARCH
Summary: Cornerstone Search Group has been retained by a publicly-traded, cutting-edge, late-stage biotech that has a robust clinical-stage pipeline across multiple therapeutic areas that is built upon their first-in-class biologics platform. Cornerstone has a long-term relationship with our client, having helped them hire many of their key executives. As they are anticipating filing multiple BLAs in the US/Europe/Asia in the relative near future, our client is seeking an experienced RA professional with the ability to work across a dynamic, global environment and serve as the RA voice across the executive leadership team, cross-functional internal teams (including Business Development), as well as with all regulatory agencies (FDA, EMA, PMDA, NMPA, etc.). You will serve as the RA strategic leader, navigating their first BLA submission process. While you will have a team of direct reports, this position requires a hands-on leader with the ability to influence across the organization and externally.
Position Title: Vice President, Global Regulatory Affairs
Location: New York/New Jersey Metro Area.
Our client’s location is convenient for people who live in North/Central NJ, New York City, Southern NY State, and Southwest Connecticut. This allows you to live in NYC or in smaller cities or suburban locations, with many featuring top-notch school systems. They are also located near other pharmas, biotechs, finance, IT, and a multitude of other industries.
Attractive Features About This Position and Company:
- Visibility: A challenging, highly-visible role where you will work alongside C-level executives, including the CEO.
- Innovative Company: Work for a unique biotechnology platform company which is focused on innovative/ground-breaking/first-in-class therapies.
- Stability & Growth: As compared to many biotechs, our client has a strong multi-therapeutic pipeline (multiple phase III studies), has developed their own cutting-edge biologics platform, has an approved product, and is publicly traded. In other words, they are not a “one compound company”.
- Unique Culture: Work in a very collegial, fast-paced environment that allows for faster decision-making and creative approaches to getting things done with the ultimate goal in mind of helping patients.
- Exciting Newly-created, Impactful Leadership Role: This is a newly created position with the ability to immediately influence the organization. You will strategically and operationally lead the BLA process from day one.
- Financial Stability & Opportunity: Our client is very well-funded as compared to other peers. Furthermore, you will have the opportunity for a strong stock package so that you can financially be rewarded for the value you bring.
- “Best of Both Worlds”: Our client combines the attractive features of a quickly growing, entrepreneurial Biotech (small team comradery, fast-paced, high-impact, agility, minimal layers of management and “red tape,” swifter decision making [i.e. emphasis on progress and moving things forward], with the benefits of a larger company (stability afforded by having an approved product, partnerships in place with larger companies, they’re already publicly-traded, high quality health insurance, etc.)
- As the SME and leader of RA, you will develop the Regulatory Affairs strategy and operational development for all programs.
- Maintain and develop the current RA team and its future build out.
- Manage external vendors.
- Align regulatory strategy globally related to development plans as well as to specific disease states/trends.
- Manage the Regulatory activities in order to meet FDA, EMA, and other global health authority requirements for all clinical (IND to BLA) and post-marketing activities.
- Manage the preparation of regulatory submission documentation, including BLA preparation, INDs, Drug Safety Update Reports, annual reporting requirements, regulatory agency materials and global clinical trial applications (CTAs).
- Manage compliance reviews of materials for regulatory submission, or for the use in advertising and/or promotion of products.
- Define gaps and limitations in regulatory documentation and facilitate mitigation actions to address them – both product development and clinical development.
- Coordinate critical reviews and provide strategic input on regulatory filing documents.
- Provide regulatory strategy input and guidance to business development activities.
- Provide input to the departmental budget based on expected deliverables for the nominated fiscal year.
Skills / Experiences / Education Sought:
- 10+ years of relevant Regulatory Affairs experience, ideally including both US and global experience.
- Prior NDA/BLA submission experience.
- Prior experience leading clinical stage and submission negotiations with health authorities.
- Experience working in a smaller, fast-paced environment with the ability to influence across the organization to include C-level executives is a plus.
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
About Cornerstone Search Group: Recognized by Forbes as one of the Top Executive Search Firms in the USA (2017 & 2018), we are an industry-leading Pharma & Biotech Executive Search Firm that works with small biotech startups all the way through to large branded & generic pharmas. We are particularly known for our long history of success in helping small, lesser-known US and Internationally-based pharmas/biotechs compete for top talent at the Director, VP, and CxO (CEO, CMO, CSO, CCO] levels.
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