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. is a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance technology (ImmTOR) platform.
Selecta plans to combine ImmTOR with a range of biologic therapies for rare and serious diseases that require new treatment options due to high immunogenicity. The company’s current proprietary pipeline includes ImmTOR-powered therapeutic enzyme and gene therapy product candidates. SEL-212, the company’s lead product candidate, is being developed to treat chronic refractory gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta’s proprietary gene therapy product candidates are in preclinical development for certain rare inborn errors of metabolism and incorporate ImmTOR with the goal of addressing barriers to repeat administration. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com.
Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).
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