Manager, Regulatory Affairs - CMC

MSD; Hyderabad; Hybrid; INR 1,800,000 - 3,000,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

MSD in Hyderabad, India seeks a Regulatory CMC professional to implement global regulatory strategies, prepare CMC dossiers, and review submissions for commercial products. You will liaise with global teams to ensure regulatory conformance and timely milestones across the product lifecycle.

The role requires strong communication, documentation review and experience with eCTD, with travel as needed in a global biotech environment. Hybrid work arrangement is available.

Qualifications

• Bachelor’s in Science or Engineering; 5–7 years in pharma industry.
• Experience managing CMC regulatory submissions for small molecules/vaccines/biologics.
• Willingness to travel as needed.

Responsibilities

• Develop and review CMC submission components for post-approval changes.
• Advise on global regulatory requirements and risk mitigation.
• Coordinate with global teams and external partners to ensure compliance.
• Communicate regulatory statuses to management.

Skills

Adaptability

Regulatory submissions

Global coordination

Communication skills

Leadership

Documentation review

Education

Bachelor’s in Science/Engineering

Tools

eCTD

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 include, but are not limited to:

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. We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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 {+ 7 more}

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s):

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.