Senior Regulatory Affairs Consultant, CMC – Post-Approval Vaccines

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic guidance and oversight for CMC components of late-stage and marketed products.

• Develop and manage CMC strategies for product development, registration, and lifecycle management.

• Lead intricate regulatory submissions, including INDs, IMPDs, BLAs, MAAs, post-approval variations and supplements, as well as responses to inquiries from health authorities.

• Author and review essential regulatory submissions, ensuring alignment with health authority guidelines and regulations.

• Facilitate submission preparation meetings with integrated cross-functional input.

• Direct regulatory CMC discussions and engagements with health authorities.

• Represent the company in high-level discussions with regulatory agencies while nurturing relationships with regulatory stakeholders.

• Develop strategies for complex regulatory inquiries and handle sensitive regulatory correspondence.

• Oversee regulatory evaluations of manufacturing modifications and establish data requirements for associated submissions.

• Act as the representative for Regulatory CMC at project team meetings and governance committees.

• Collaborate with R&D, Manufacturing, Quality Assurance, Clinical Development, external partners, and regulatory authorities.

• Provide updates to senior management regarding project status, risks, and milestones.

• Mentor and cultivate team members in Regulatory CMC practices and strategic thought processes.

• Monitor the evolution of CMC regulations and industry best practices to devise innovative regulatory strategies.

⛳️ Requirements

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline.

• A minimum of 10+ years of experience in Regulatory Affairs, concentrating on CMC for late-stage and marketed products.

• Comprehensive understanding of global CMC regulatory requirements, submission processes, and expectations from health authorities.

• Profound knowledge of pharmaceutical development, manufacturing processes, and quality systems.

• Demonstrated success in regulatory submissions and favorable interactions with health authorities.

• Strong analytical, communication, organizational, and problem-solving abilities.

• Exceptional project management skills with the capacity to influence and lead at senior levels.

• Experience in a regulated pharmaceutical environment, with a focus on CMC for late-stage and marketed products.

• Ability to collaborate with senior leadership teams, influence cross-functional stakeholders, and communicate effectively at all levels.

• Comfort with global regulatory submission processes, health authority expectations, and quality systems.

🏝️ Benefits

• Health, Vision & Dental Insurance.

• Tuition Reimbursement.

• Vacation/Holiday/Sick Time.

• Flexible Spending & Health Savings Accounts.

• Work/Life Balance.

• 401(k) with Company match.

• Pet Insurance.

• Some roles may also qualify for additional incentives, bonuses, or other compensation programs.