Merck Limited Hiring Regulatory Affairs Assoc. Scientist

Merck Limited Hiring Regulatory Affairs Assoc. Scientist

Merck Limited (formerly E. Merck Limited) was set up in India as the first Merck subsidiary in Asia in 1967.  The Company operates both its Pharmaceuticals and Chemicals businesses in the country. Merck was also the first Merck Group Company to go public in the year 1981. The Merck Group now holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd.

Post : Assoc. Scientist, Regulatory Affairs-CMC

Job Description
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

Candidate Profile
• 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
• 0 – 3 yrs of Industry Pharmaceutical industry experience
• 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

Additional Information
Experience : 0 – 3 yrs
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