Global Regulatory CMC Lead

Coordinate regulatory CMC activities for one or more products across all lifecycle stages. Develop global regulatory CMC strategies, collaborate with stakeholders, and guide product teams. Prepare CMC and Quality-related agency correspondence and regulatory applications while managing multiple projects in a fast-paced environment.

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 compliance 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 for 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 applicability and impact.

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 roles.
• 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.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment to meet critical regulatory milestones.
• Ability to work independently with exceptional written and oral communication skills.

Benefits

• Competitive healthcare, plus voluntary benefit programs to support unique needs.
• Holistic well-being support, including fitness, mindfulness, and mental health resources.
• 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 programs 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 competencies, education, qualifications, certifications, experience, skills, performance, and business needs. Eligibility for an annual discretionary bonus, other incentive compensation, or equity award may apply, subject to company plan criteria and individual performance.

Schedule

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