Associate Director, Global Regulatory, CMC

Coordinate regulatory CMC activities for one or more products through all stages of the product lifecycle. Develop global regulatory CMC strategies and collaborate with key stakeholders to execute these strategies in alignment with business priorities. Provide guidance to product teams and prepare CMC and Quality-related agency correspondence and regulatory applications.

Responsibilities

• Develop and 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 conformity with 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
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls
• Interpret regulatory guidance documents, regulations, and directives; advise Manufacturing, Quality, and Process/Analytical Development groups on their applicability and impact on internal programs

Requirements

• BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field
• 8+ years of experience in the pharmaceutical/biotech industry, with a focus on manufacturing and/or analytical areas
• 5+ years of experience in Biologics-focused Regulatory CMC
• Strong knowledge of current Global CMC regulations, including 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

Skills

• Ability to effectively collaborate in a dynamic, cross-functional matrix environment to meet critical regulatory milestones
• Ability to work independently
• Exceptional written and oral communication
• Desire to make an impact as part of a high-growth, transformational company

Benefits

• Best-in-class healthcare coverage, plus voluntary benefit programs to support unique needs
• 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 plan for the future
• Location-specific perks and extras

Pay

The salary range for this role is $142,500.00 - $256,500.00. An individual’s position within the salary range will be based on factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

Schedule

This role follows a 70/30 work model, with 70% in-office collaboration to foster innovation, teamwork, and direct mentorship.