Associate Director, Global Regulatory, CMC

The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. The individual will be expected to provide guidance to the product teams and will be responsible for preparation of CMC and Quality related agency correspondence and regulatory applications. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. Development of regulatory strategy for the products in our portfolio will be a key success component.

Responsibilities

Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks; Provide guidance for regulatory CMC aspects of product development projects; Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines; Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions; Perform assessment of manufacturing change controls; Support development of regulatory processes and procedures to support CMC components of regulatory submissions; Support the creation and maintenance of CMC submission templates; Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls; Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs

Requirements

BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required; 8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus; 5+ years of experience in Biologics focused Regulatory CMC; Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions; Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance

Nice to have

Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones; Ability to work independently; Exceptional written and oral communication; A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

Benefits

Competitive healthcare, 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 investments to help you plan for the future; Location-specific perks and extras; Potential eligibility for an annual discretionary bonus, other incentive compensation, or equity award