The Role This role plays a critical part in ensuring global regulatory success by providing leadership, expertise, and strategic direction for Chemistry, Manufacturing, and Controls (CMC) activities across the product lifecycle.
Key Responsibilities Ensure global regulatory compliance by aligning external regulatory requirements with internal quality systems and procedures Apply regulatory expertise, sound judgment, and cross-functional collaboration to develop and implement effective CMC regulatory strategies Design and execute robust regulatory plans to proactively mitigate risk and address technical and scientific challenges Prepare, review, and submit high-quality CMC documentation to global regulatory authorities, managing timelines and regulatory commitments Act as the CMC regulatory representative on project teams, assessing risks and contributing to global regulatory strategy development Support post-approval changes, new registrations, renewals, and responses to regulatory authority questions Perform quality and compliance reviews of CMC regulatory submissions Build and maintain strong working relationships with internal stakeholders and external partners, including regulatory agencies Mentor and guide colleagues by providing technical expertise and regulatory insight to strengthen team capabilities Represent the organization at industry forums, conferences, and advisory committees, as appropriate Contribute to CMC-related projects, initiatives, and training activities while upholding organizational values, integrity, and compliance standards Qualifications, Skills & Experience Degree in Natural Sciences or a related discipline Minimum of 6 years' experience within the pharmaceutical industry, including relevant technical experience (e.g., Quality, Technical Services, or R&D) At least 3 years' experience in pharmaceutical regulatory affairs A minimum of 2 years' hands-on CMC authoring experience, including initial marketing applications and/or post-approval variations Strong understanding of c GMPs and both development and commercial manufacturing activities Demonstrated knowledge of global regulatory requirements, submission pathways, and regulatory authority interactions Proven ability to interpret and apply global and regional CMC guidelines to inform regulatory strategy Awareness of emerging scientific, manufacturing, and technological trends and their impact on regulatory approaches Skills: Regulatory CMC approvals manager RA