Reporting to the CMO, in this newly created position, the Vice President of Regulatory Affairs will be responsible for all aspects of Regulatory Affairs related to clinical development, CMC and commercialization. The Vice President of Regulatory Affairs will lead the strategic direction and operational aspects of regulatory compliance and submissions for all projects across the company. The VP will be responsible for coordinating regulatory activities across functions in the organization, including CMC, pre-clinical, and discovery, as well as clinical. Position will be responsible for developing the strategic plan for obtaining approval for compound in the pipeline and for developing strong relationships with the FDA and other global regulatory agencies. The candidate will also be responsible for building the appropriate sized internal support and managing the external support to implement and execute the strategic plan to ensure rapid and timely approvals that will lead to the achievement of Selecta’s business objectives.
- Formulate, create and implement a regulatory strategy and related activities needed to secure approvals
- Develop and implement strategies for timely submission and approval of regulatory submissions from IND through BLA
- Ensure regulatory compliance of marketed and investigational drugs with the FDA and other applicable regulatory jurisdictions, in cooperation with partner organizations when applicable (e.g. EMA)
- Act as the independent subject matter expert in giving guidance to project teams, departments, and management, while considering companywide implications
- Monitor the regulatory process to ensure company compliance with all regulatory commitments, obligations and interactions
- Manage the compilation, submission and maintenance of INDs, BLA’s and amendments
- Actively participate on project teams providing regulatory strategy, guidance and compliance oversight for Selecta’s product candidates
- Identify and assess regulatory risks for assigned projects or programs
- Bachelor’s Degree in a scientific discipline required
- Advanced degree preferred (MS/PhD/PharmD)
- 15+ years of industry experience, with at least 10 years working in regulatory affairs (regionally or globally)
- Regulatory experience with biologics including delivery of major applications (such as BLA/MAA) and securing approval
- Experience with early/mid/late stage development and marketed products
Knowledge, Skills and Other Experience
- Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
- Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
- Substantial experience in representing the sponsor and interfacing and negotiating with regulatory authorities (e.g. FDA, EMA)
- Demonstrated leadership ability as well as ability to be a team player and work well within cross-functional teams
- Ability to motivate and lead others
- Excellent oral communication and writing skills Change management/ change enabler : embraces the challenges of a fast changing environment
- Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
- Excellent operational skills
- Unquestionable ethics, professional integrity, and personal values consistent with the Selecta Biosciences values
- Travel: Up to 25% of the time, including international travel
About Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses.
With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. The company’s first program aimed at addressing immunogenicity to AAV gene therapies is expected to enter clinical trials in early 2021 in partnership with AskBio for the treatment of methylmalonic acidemia (MMA), a rare metabolic disorder. A wholly-owned program focused on addressing IgA nephropathy driven by ImmTOR and a therapeutic enzyme is also in development among additional product candidates. Selecta recently licensed its Phase 3 clinical product candidate, SEL-212, in chronic refractory gout to Sobi. For more information, please visit www.selectabio.com.
Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).
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