Manager, Regulatory Affairs - CMC

MSD Malaysia; Maharashtra; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

MSD Malaysia is seeking a Regulatory Affairs professional to implement CMC regulatory strategies for assigned pharmaceutical products in line with global regulations and strategies.

You will prepare and review CMC dossiers for commercial products and collaborate with global CMC teams, manufacturing and external partners to ensure regulatory conformance throughout the product lifecycle.

Qualifications

• Bachelor’s in Science, Engineering, or related field; advanced degree preferred.
• 5–7 years pharma industry experience with CMC regulatory submissions for small molecules/vaccines/biologics.
• Willingness to travel to other CMO sites as needed.

Responsibilities

• Provide input to global product and project regulatory strategies by assessing CMC changes and requirements.
• Lead development, authoring and review of CMC submission components for post-approval filings.
• Coordinate with global CMC, Manufacturing and external partners for compliant change management.
• Assess regulatory risks and propose mitigation strategies for assigned products.
• Deliver regulatory milestones across the product lifecycle and communicate issues to GRACS.

Skills

Regulatory strategy

CMC submissions

Regulatory affairs

Communication skills

Leadership

Global coordination

Documentation review

Education

Bachelor’s in Science/Engineering

Advanced degree preferred

Job description

Job Description

This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance’s and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Your role at our organization is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

Primary Responsibilities

Regulatory Responsibilities: Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks. Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements/variations, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Liaise with global CMC, Our Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Identify and communicate potential regulatory issues to GRACS CMC management, as needed.

Technical Skills

Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data. Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills. Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance). Proficient computer skills and previously demonstrated ability to operate in electronic document based GMP systems.

Leadership Skills

Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Capability to handle multiple priorities and balance work to achieve business goals. Demonstrated effective leadership, communication, and interpersonal skills.

Qualifications & Skills

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. Minimum 5 – 7 yrs of Industry Pharmaceutical industry experience out of 4 years’ experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics. The candidate may be required to travel to other CMO sites on a need basis.

Required Skills

• Adaptability


• Adaptability


• Business Decisions


• Change Controls


• Collaborative Leadership


• Compliance Investigations


• Documentation Review


• Documentation Standards


• Electronic Common Technical Document (eCTD)


• Employee Training Programs


• Global Coordination


• Global Regulatory Submissions


• Legal Compliance


• Life Cycle Planning


• Pharmaceutical Manufacturing


• Pharmaceutics


• Policy Implementation


• Records Retention Management


• Regulatory Affairs Management


• Regulatory CMC


• Regulatory Communications


• Regulatory Compliance


• Regulatory Documents


• Regulatory Management


• Regulatory Processes

Employment Details

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: No

Travel Requirements: 50% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): NA

Job Posting End Date: 10/6/2026

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.