Online Jobs as Regulatory Affairs CMC Manager at MSD

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Post : Manager - Regulatory Affairs CMC

Job Description
As part of the Global Regulatory Affairs & Clinical Safety (GRACS) CMC Change Control & Dossier Management team, the Small Molecule Change Control Lead will be responsible for administration of commercial manufacturing change controls from initial authorization throughout the project’s lifecycle to completion. The candidate serves as the primary point of contact for the Business Process Team to the Small Molecule CMC Team to develop and manage operational activities associated with the commercial Small Molecule Change Control. The position is expected to routinely update and report to Small Molecule Leadership on project status and issues of active change controls.

The candidate is expected to have prior experience in quality and quality management systems, knowledge of CMC Regulatory documentation (dossier structure, filing strategy), and an understanding of large molecule commercial manufacturing process. The candidate will be required to utilize principles for effective project management and business process design to facilitate meetings and resolve bottlenecks in the progress of commercial Small Molecule change controls.

Primary responsibilities
• Collaborating across Global Regulatory Affair and Clinical Safety (GRACS) CMC functional area (site CMC, International CMC, Project Management Organization (PMO), Business Process Team etc.) and Merck Manufacturing Division (MMD) partners to ensure commercial change control projects and related activities are on track per program objectives for the Small Molecule Franchise
• Aligning, monitoring and reporting commercial change control project status for the Small Molecule Franchise
• Applying knowledge of scientific and quality principles, regulatory requirements, change control standards, and GMP practices to optimize the workflow for the commercial Change Control
• Applying principles of project management to plan and perform appropriate work during each phase of the projects process
• Identifying opportunities for innovative improvements to enhance communication, planning, organization, and daily operations to ensure timely tasks delivery
• Applying quality, Change Control (GCM Trackwise) and Health Registration Management (HRM) systems knowledge to support daily operational needs
• Collaborating with Business Process Lead and the Small Molecule Franchise to develop and deliver IT enabled solutions for progression of change controls from authorization to completion
• Demonstrating capabilities of critical thinking to understand change control dependencies and intricacies and articulating logical pragmatic solutions
• Leading small cross-functional teams to meet project milestones and demonstrating leadership necessary to build and maintain high quality change control assessments

Candidate Profile
• Minimum of 5 years’ experience with BS in Science or Engineering. Experience should be in pharmaceutical/biotechnology or Small Molecule industry with experience in a quality, or compliance, or Regulatory role (e.g., manufacturing, process development, analytical, quality assurance).
• Effective communication, negotiation, problem-solving, and interpersonal skills with a working knowledge of project management to perform job responsibilities.

Additional Information
Qualification : B.Sc, B.E
Location : Platina, Mumbai
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 30th April, 2020