Join Merck Limited as an Associate Scientist in Regulatory Affairs-Apply before 20th April 2024

Merck Limited

Website Merck Limited

About Merck Limited

Merck Limited, previously known as E. Merck Limited, was established in India in 1967, marking it as the inaugural Merck subsidiary in Asia. The company functions in both the Pharmaceuticals and Chemicals sectors within the nation. Notably, Merck Limited was the pioneering Merck Group entity to undergo public offering, which occurred in 1981. Presently, the Merck Group retains a majority share of 51% in Merck Limited, with the remaining 49% being publicly traded on the Bombay Stock Exchange Ltd.

Post: Assoc. Scientist, Regulatory Affairs-CMC

Job Description

Regulatory Responsibilities:

  • Global Regulatory Strategy: Provide input to global product and project regulatory strategies by assessing CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks.
  • Execution of Regulatory Strategies: Lead 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. Ensure compliance with established business processes and systems.
  • Collaboration and Liaison: Liaise with global CMC, Our Manufacturing Division, and external partners to ensure compliant execution of change management activities while maintaining a focus on regulatory conformance.
  • Risk Assessment and Mitigation: Assess and communicate potential regulatory risks, proposing mitigation strategies to ensure regulatory milestones are achieved across the product lifecycle.
  • Issue Identification and Communication: Identify and communicate potential regulatory issues to GRACS CMC management as necessary.

Technical Skills:

  • Scientific Review: Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale, ensuring clarity in presentation and adequate support by data.
  • Communication: Demonstrated oral and written communication skills, with the ability to communicate issues succinctly and logically. Strong listening skills are essential.
  • Understanding of Related Fields: Demonstrated understanding of related fields such as pharmaceutical manufacturing, analytical testing, and quality assurance.
  • Computer Proficiency: Proficient computer skills, with demonstrated ability to operate in electronic document-based GMP systems.

Candidate Profile

  • Education: Bachelor of Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
  • Experience: 0 – 3 years of industry experience in the pharmaceutical sector.
  • Problem-Solving Skills: Demonstrated ability to generate innovative solutions to problems and effectively communicate with key stakeholders.
  • Adaptability: Demonstrated flexibility in responding to changing priorities or unexpected events.
  • Time Management: Capability to handle multiple priorities and balance work to achieve business goals.
  • Interpersonal Skills: Demonstrated effective leadership, communication, and interpersonal skills.

Additional Information

  • Experience: 0 – 3 years
  • Qualification: B.Pharm, B.Sc
  • Location: Mumbai, Maharashtra; Pune, Maharashtra; Hyderabad, Telangana
  • Industry Type: Pharma/ Healthcare/ Clinical Research
  • Functional Area: Regulatory Affairs – CMC
  • End Date: 20th April 2024
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