Executive Director, CMC Regulatory Science

The individual in this position will be based at Norwood MA site and will be responsible for managing a team of CMC experts that prepare and oversee CMC and Quality related agency correspondence and regulatory applications. This position will be required to oversee the product strategy for all the products in their portfolio and lead and support all regulatory activities to provide high quality CMC sections of regulatory documentation. Additionally, interfacing with the leadership in our departments and assuring clear communication of regulatory topics is critical. Reg CMC strategy development to align with the needs of the company, the regulators and the patients will be a key component.

Responsibilities

Lead a team to develop/implement effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks; Provide expertise for regulatory CMC aspects of product development projects; Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines and meet the needs of the company; Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions at the expert level; Develop regulatory processes and procedures to support CMC components of regulatory submissions; Support the creation and maintenance of CMC submission templates; Provides CMC regulatory expertise to manufacturing and quality teams; evaluates CMC change controls; Provides interpretation of domestic and international regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs. Be a site expert.; Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) and drive Reg CMC strategy successfully

Requirements

MS/PhD degree in a scientific/engineering discipline; 10+ years of experience in the pharmaceutical/biotech industry; 8+ years of experience in Regulatory CMC, including DMF/ASMF submissions; Strong knowledge of current US, EU, and ROW regulations; Strong experience with CTD format and content regulatory filings; Exceptional written and oral communication

Nice to have

MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable; 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus; 8+ years of experience in Biologics focused Regulatory CMC

Benefits

Best-in-class healthcare coverage, plus voluntary benefit programs; A holistic approach to well-being, with access to fitness, mindfulness, and mental health support; Family planning benefits, including fertility, adoption, and surrogacy support; Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown; Savings and investment opportunities to help you plan for the future; Location-specific perks and extras; Annual discretionary bonus; Other incentive compensation; Equity award