Associate Principal Scientist, Regulatory Chemistry Manufacturing – Controls CMC Product Lead

This is a fully remote position, open to applicants in United States, +4 more locations.

📋 Description

• Formulate and execute Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for designated small molecule or biological products.

• Act as the CMC Product Lead, achieving regulatory milestones throughout the product's lifecycle.

• Direct global product and project regulatory strategies.

• Create, author, and review components and documentation for CMC submissions.

• Prepare and file CMC dossiers for lifecycle maintenance submissions, original registrations, and post-approval modifications.

• Assist with post-approval supplements, annual reports, registration renewals, and responses to inquiries from health authorities.

• Offer regulatory leadership for product in-license/due diligence reviews, divestments, and withdrawals.

• Collaborate with Manufacturing & Supply teams and external partners on compliant change management processes.

• Evaluate and communicate regulatory risks while recommending mitigation strategies.

• Identify, convey, and escalate regulatory issues to Regulatory CMC management.

• Oversee a team of 1 to 2 individual contributors and/or outsourcing partners as necessary.

• Support project team objectives and organizational initiatives.

⛳️ Requirements

• Bachelor’s degree in a science, engineering, or related discipline with a minimum of 7 years of relevant experience, encompassing biological/pharmaceutical research, manufacturing, testing, or a related area; OR an advanced degree (MS, MBA, Ph.D., PharmD) with at least 4 years of pertinent experience.

• Proficient in English; additional language capabilities are advantageous.

• Demonstrated experience in critically evaluating detailed scientific information and assessing technical merits and scientific rationale.

• Excellent oral and written communication abilities in multicultural environments.

• Comprehension of related fields such as manufacturing, analytical processes, and quality assurance.

• Capacity to devise innovative solutions for complex regulatory challenges.

• Adaptability in responding to shifting priorities or unforeseen circumstances.

• Strong leadership, communication, interpersonal, and negotiation skills.

• Ability to guide direct or matrixed colleagues to fulfill business commitments and project schedules.

• Experience in Regulatory CMC post-approval lifecycle management is preferred.

• Must meet applicable travel and credentialing criteria, including vaccination requirements.

• No visa sponsorship available.

🏝️ Benefits

• Retirement savings plan.

• Paid vacation and holiday time.

• Paid caregiver/parental and medical leave.

• Health benefits, including medical, prescription drug, dental, and vision coverage.

• Flex Time.

• Remote Work.