R&D GRA CMC Lead

Develop and implement global regulatory CMC strategies, create strategies for development and marketed products, focus on chemical entities, biological entities, and/or vaccine products, execute and adapt strategies as needed

Serve as the primary point of contact for regulatory authorities, Act as direct liaison with agencies like US FDA and EMA, Develop positive relationships with regulators ,Support strategic negotiations with worldwide Regulatory Health Authorities

Manage CMC documentation and submissions, Write, prepare, review, and approve regulatory CMC dossiers, ensure dossiers meet quality standards, comply with regulatory requirements, Maintain documentation accuracy and completeness

Lead cross-functional collaboration, work closely with R&D Functions, Collaborate with Manufacturing & Supply Functions, Coordinate with GRA Regulatory Operations, ensure effective implementation of regulatory strategies, Facilitate resolution of CMC issues

Identify and manage regulatory risks, assess regulatory CMC opportunities and risks, develop risk mitigation strategies, communicate implications to project teams, Articulate risk/benefit components to stakeholders

Contribute to regulatory science and policy activities, monitor local and international Health Authority regulations and guidelines, participate in the review process for new regulations, anticipate potential regulatory paradigm shifts, Track and communicate current Health Authority thinking and trends

• Experience in the pharmaceutical industry with strong expertise in CMC Regulatory Affairs.
• Strong understanding of drug development, manufacturing, and testing processes, Good understanding of Artificial Intelligence applications in regulatory affairs
• Experience with combination (drug/device) productsAdvanced proficiency in regulatory documentation preparation
• Comprehensive knowledge of global regulatory requirements, Experience with complex regulatory submissions
• Demonstrated leadership in matrix environment,Proven ability to influence cross-functional stakeholders
• Experience managing multiple high-priority products simultaneouslyAdvanced communication skills with ability to persuade and negotiate
• Strong mentoring capabilitiesStrategic thinking and decision-making abilities
• Advanced communication skills with ability to persuade and negotiate Stakeholder management Adaptability & flexibility Critical thinking & Problem-solving Teamwork & collaboration Time management Emotional intelligence (EQ)Compliance & quality mindset Proactive ownership Presentation skills
• Technical skills: Strategic ThinkingResults-Oriented People LeadershipInfluencing Others Regulatory Strategies Product Registrations Risk Management Digital AdoptionStakeholder Management Advanced proficiency in MS Office Suite & Electronic document management systems (Veeva vault, Plai)