MSD has a history of more than 130 years in the field of pharmaceuticals, during which it has contributed to improving global health through the development of important medicines and vaccines. The company aspires to be the leading research-intensive biopharmaceutical company worldwide. This signifies a commitment to research and innovation in the field of biopharmaceuticals. MSD is actively involved in cutting-edge research to create innovative health solutions that advance disease prevention and treatment, benefiting both humans and animals. MSD operates with a sense of responsibility, aiming to make a positive impact on society every day. This includes ensuring safety, sustainability, and the promotion of a healthy future for all people and communities.
Job Post: Manager, Regulatory Affairs – CMC
Job Description:
Responsibilities:
Implement CMC Regulatory Strategies: Develop and execute CMC regulatory strategies for pharmaceutical products, ensuring compliance with global regulations and guidance.
Dossier Preparation: Prepare and review information required for the development of regulatory CMC dossiers for commercial products.
Facilitating Medical Advancements: Contribute to bringing new medical advancements to the world by facilitating communications and procedures for regulatory compliance.
Global Healthcare Breakthroughs: Be part of an international network at the forefront of healthcare breakthroughs, delivering new, reliable, and compliant medical products and solutions.
Integral Role: Your role is integral to advancing global medical knowledge and contributing to healthcare breakthroughs that impact future generations.
Regulatory Responsibilities:
Global Regulatory Input: Provide input to global product and project regulatory strategies, assess CMC changes, and evaluate documentation for acceptability and potential risks.
CMC Submission: Lead the development, authoring, and review of CMC submission components and documentation.
Collaboration: Collaborate with global CMC, Manufacturing Division, and external partners for regulatory conformance.
Risk Assessment: Identify and communicate potential regulatory risks and propose mitigation strategies.
Regulatory Milestones: Deliver all regulatory milestones for assigned products across their lifecycle.
Issue Reporting: Identify and communicate potential regulatory issues to GRACS CMC management.
Technical Skills:
Scientific Assessment: Review scientific information to assess technical merits and suitability of scientific rationale.
Communication Skills: Demonstrate strong oral and written communication skills and the ability to communicate complex issues clearly.
Understanding of Related Fields: Possess understanding of related fields, including pharmaceutical manufacturing, analytical testing, and quality assurance.
Computer Proficiency: Proficient in computer skills and electronic document-based GMP systems.
Leadership Skills:
Innovative Problem Solving: Demonstrate the ability to generate innovative solutions to problems and work effectively with key stakeholders.
Adaptability: Be flexible in responding to changing priorities and unexpected events.
Multi-Tasking: Manage multiple priorities and balance work to achieve business goals.
Effective Leadership: Possess effective leadership, communication, and interpersonal skills.
Candidate Profile:
Educational Background: Bachelor’s in science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
Experience: Minimum 5 – 7 years of industry pharmaceutical experience, with at least 4 years managing CMC Regulatory submissions for small molecules, vaccines, or biologics. Travel to other CMO sites may be required on a need basis.
Additional Information:
Experience Required at MSD: 5 – 7 years
Qualification Required at MSD: Degree in Sciences; Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry
Location: Mumbai, Pune
Industry Type: Pharma/ Healthcare/ Clinical research
