Senior Manager, CMC Regulatory Affairs

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

📋 Description

• Assist in the formulation and implementation of global CMC regulatory strategies for clinical development initiatives and initial marketing submissions, aligning with business goals and regulatory standards.

• Oversee post-approval CMC regulatory lifecycle management tasks, including strategy creation and execution for variations, supplements, renewals, annual reports, and other submissions post-approval.

• Aid in the preparation, review, compilation, maintenance, and submission of CMC regulatory dossiers (Modules 2.3 and 3) and associated documentation for clinical and commercial products, including INDs, IMPDs, CTAs, NDAs, MAAs, amendments, and lifecycle management submissions.

• Assist in the preparation and coordination of responses to inquiries from health authorities, deficiency letters, information requests, and regulatory commitments.

• Facilitate cross-functional collaboration with Technical Operations, Manufacturing, Analytical Development, Quality Assurance, Supply Chain, and external partners to ensure the timely execution of CMC regulatory strategies, submissions, and post-approval commitments.

• Maintain regulatory documentation systems and repositories, ensuring version control, traceability, inspection readiness, and compliance.

• Conduct change control assessments and regulatory impact evaluations to determine suitable filing strategies and reporting obligations globally.

• Collaborate with cross-functional teams to aid in regulatory assessments and filing strategies for changes in manufacturing, analytical processes, specifications, facilities, packaging, labeling, and supply chains.

• Track evolving global regulatory requirements and assist in implementing regulatory strategies to uphold compliance throughout the product lifecycle.

• Ensure the timely delivery of high-quality, submission-ready regulatory packages that align with project timelines and regulatory milestones.

• Support health authority inspections, audits, due diligence activities, and regulatory interactions.

• Assist in preparing CMC content for annual reports, regulatory maintenance reports, and other necessary regulatory updates.

• Support vendor and CRO management efforts to ensure the prompt delivery of CMC regulatory documentation and submission outputs.

• Contribute to the continuous enhancement of regulatory processes, documentation standards, templates, and submission workflows.

• Act as a CMC regulatory representative on cross-functional project teams.

⛳️ Requirements

• Bachelor's degree in a scientific field; a degree in Chemistry or an advanced degree is preferred.

• 8 years of experience in the pharmaceutical industry, with at least 6 years focused on Regulatory affairs.

• Demonstrated experience in supporting CMC regulatory submissions, including INDs, IMPDs, CTAs, NDAs, MAAs, ANDAs, and post-approval lifecycle management activities.

• Familiarity with global regulatory filings and interactions with health authorities, including the FDA, EMA, and other international regulatory agencies.

• Strong understanding of FDA regulations, ICH guidelines, and global regulatory requirements related to pharmaceutical development, registration, change control, and post-approval reporting.

• Solid grasp of GxP standards, quality systems, policies, and procedures.

• Experience in regulatory assessment related to manufacturing, analytical, process, specification, facility, packaging, labeling, and supply chain alterations.

• Knowledge and experience in drug substance and drug product development, manufacturing processes, analytical testing, and control strategies; experience with small molecules is preferred.

• Experience collaborating with CMOs, CDMOs, and external regulatory partners.

• Proficiency with electronic document management systems, submission platforms, and regulatory information management tools.

• Exceptional verbal, written, and interpersonal communication abilities.

• Strong project management and organizational capabilities.

• A collaborative problem-solver with the capacity to assess regulatory risks and devise practical solutions.

• Ability to work independently and effectively within cross-functional and global teams.

• Experience in supporting regulatory inspections, audits, due diligence activities, and interactions with health authorities is preferred.

• Willingness to travel domestically and internationally as needed (approximately 5–10%).

🏝️ Benefits

• We provide a competitive base salary.

• Annual bonus.

• Long-term incentives.

• Comprehensive benefits package.

• Health insurance.

• Dental and vision coverage.

• Term life and disability coverage.

• Retirement plans.