Manager, Regulatory Affairs – CMC

MSD

. Implement CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance, and defined regulatory strategies .

Posted 9/29/2026full-timeHyderabad • IndiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC regulatory strategies and submissions for pharmaceutical products, with a strong understanding of global regulations and compliance. Capable of leading cross-functional teams and effectively communicating regulatory risks and solutions.

Highest-signal resume keywords

CMC Regulatory Submissions ManagementPharmaceutical Industry ExperienceScientific Information ReviewLeadership and Communication SkillsGMP Systems Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Regulatory StrategiesRegulatory Dossier PreparationRisk AssessmentPost-Approval Submission DevelopmentPharmaceutical Manufacturing KnowledgeAnalytical Testing UnderstandingQuality AssuranceTechnical Merits AssessmentInnovative Solution GenerationStakeholder Collaboration

Soft Skills

Effective LeadershipInterpersonal SkillsOral CommunicationWritten CommunicationFlexibility in Prioritization

Tools & Technologies

Electronic Document-Based GMP Systems

Industry Keywords

Pharmaceutical ProductsSmall MoleculesVaccinesBiologicsRegulatory MilestonesChange ManagementHealth Authority ResponsesCommercial ProductsRegulatory RisksCMO Sites

About the role

Key responsibilities & impact

Implement CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance, and defined regulatory strategies
Prepare and review information required for regulatory CMC dossiers for commercial products
Provide input to global product and project regulatory strategies by assessing CMC changes and identifying global regulatory requirements
Evaluate supporting documentation for acceptability and potential risks
Lead development, authoring, and review of CMC submission components for post-approval supplements/variations, annual reports, registration renewals, and health authority responses
Liaise with global CMC, Manufacturing, and external partners to support compliant change management
Assess and communicate regulatory risks and propose mitigation strategies
Deliver regulatory milestones across the product lifecycle
Identify and communicate regulatory issues to GRACS CMC management as needed

Requirements

What you’ll need

Bachelor’s in Science, Engineering, or a related field
Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry
Minimum 5–7 years of pharmaceutical industry experience
4 years’ experience managing CMC Regulatory submissions for small molecules, vaccines, or biologics
Experience reviewing scientific information and assessing technical merits and scientific rationale
Demonstrated oral and written communication skills
Understanding of pharmaceutical manufacturing, analytical testing, and quality assurance
Proficient computer skills and ability to operate electronic document-based GMP systems
Ability to generate innovative solutions and work with key stakeholders
Ability to respond flexibly to changing priorities and unexpected events
Ability to handle multiple priorities and balance work to achieve business goals
Effective leadership, communication, and interpersonal skills
Valid driving license
Willingness to travel to other CMO sites as needed
Visa sponsorship is not provided

Benefits

Comp & perks

Travel requirements: 50%
Regular employee status
Domestic relocation support indicated