Regulatory Affairs Manager

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 cGMPs 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