Associate Director, Regulatory Affairs Strategy | Innovative Therapies | New Business Unit – Exciting Biopharma | Boston
Our client is a fast-growing biopharma leader focused on the development and commercialization of innovative high-potential new therapies in the rare diseases space. This is an exciting new opportunity within a new Business Unit where you will serve as the US and Global regulatory strategy lead for high-profile projects, and develop and implement regulatory strategies/objectives/policies pertaining to the development, registration, commercialization and lifecycle management of these novel therapies. You will serve as the US and International regulatory affairs subject matter expert and be a key member of the core Global Regulatory Team.
ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:
- Exciting Opportunity in New Business Unit: This is an exciting opportunity to join a new Business Unit within the organization in an impactful/influential role.
- Enjoy the Best of Both Worlds: Best of pharma and biotech: enjoy a very collaborative, intellectual and fast-paced/nimble work environment where decisions are made swiftly with minimal layers of management, while also being part of a company that has significant financial resources (i.e. cash, revenues, profits..), a strong appetite and for innovation and the perseverance/endurance to make the innovation happen (i.e. willing to significantly invest in its R&D spend and human capital too).
- Innovative Therapeutics: Work on very exciting therapeutics and be an integral part of bringing innovative new cell therapies to market.
- Track Record of Success: Join a Company that is well-positioned for sustainable long-term growth and has a track record of multiple discovery, development & FDA approval successes.
- Excellent Hiring Manager: Report into a very highly-regarded and well-respected hiring manager/Department Head.
RESPONSIBILITIES IN A NUTSHELL:
- Develops and implements innovative regulatory strategies in close collaboration with relevant R&D and Commercial functions to obtain, maintain and extend product registrations in the United States.
- Proactively identifies, assesses and mitigates regulatory risks associated with product development and maintenance for assigned projects.
- Drives the tactical implementation of strategic regulatory plans for the creation and submission of regulatory documents, e.g., INDs, NDAs/BLAs, supplemental NDAs/BLAs, CTAs, Marketing Applications, etc.
- Serves as the liaison to the US FDA and will provide support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health Authorities, including Japan, Canada, EEA and growth and emerging markets (GEM).
- Serves as a US and International regulatory strategy subject matter expert.
- Represents this Business Unit’s regulatory affairs function on internal program teams.
- Acts as a point of contact and interface with key R&D functions in the preparation, review and approval of regulatory filings to support early and late stage development assets, and the maintenance or expansion of approved therapies in the US and internationally.
- Assists in the coordination of cross-functional group of regulatory professionals as part of the Global Regulatory Team, including but not limited to RA CMC, RA Operations, Labeling, EU RA, Device RA, Advertising/Promotion and RA Intel/Policy to drive global regulatory strategies.
- May serve as direct liaison to the US FDA. Provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health Authorities.
EDUCATION & DESIRED EXPERIENCE:
- Advanced scientific or health sciences degree is preferred.
- 6+ years of relevant experience in drug/biologics development in the pharmaceutical/biotech industry, or Government Health Authorities with at least 3 years of experience in a Regulatory Affairs role.
- Strong US and international/global regulatory affairs experience.
- Extensive knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with global Regulatory Authorities.
Brian Skurka | Partner
E: firstname.lastname@example.org | P: 973-656-0220 x738
CORNERSTONE SEARCH GROUP, LLC
Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA
Recently Completed Retained Searches by Cornerstone:
- Chief Medical Officer | Clinical-stage cell therapy biotech
- Chief Medical Officer | Early/later-stage biotech | Boston area
- Chief Scientific Officer | Mid-size global biotech | I-O/Hema/Onc TAs
- President/US Commercial Head | OSD Generics start-up
- SVP, Head of Global Medical Affairs | Mid-size oncology company
- SVP, Global Regulatory Affairs | Late-stage biotech
- SVP, Translational Medicine & Early Development, Oncology | Boston Biotech
- VP, Oncology Drug Development | Emerging I-O biotech
- VP, Global Commercial Strategy – Early Pipeline | top rare disease biotech
- VP, Head of Regulatory Affairs | Boston biotech
- VP, Head of Regulatory Affairs | NYC commercial-stage biotech
- VP, Head of R&D Operations | Cambridge MA biotech
- VP, Clinical Operations | Cell/Gene Therapy Biotech
- ED, Clinical R&D, Oncology | Early-stage biotech | Boston/Cambridge
- Head of Human Resources | Clinical-stage gene therapy biotech
- Medical Director, Clinical Development – Cell/Gene Therapy | Mid-size biotech
- Medical Director, Clinical Development| Boston area biotech
Keywords: Director, Leader, Global Regulatory Affairs, US Regulatory Affairs, Strategy, plasma derived therapies, blood products, hematology, oncology, cell gene therapy, PDT, regulatory agencies, biologics, small molecules, Leader, Lead