Location: Hyderabad, Pune
Industry Type: Pharma / Healthcare / Clinical Research
Functional Area: Regulatory Affairs
Experience: 5–7 Years
Qualification: B.Pharm, B.Sc, B.E
Last Date to Apply: 30th June 2025
About MSD (Merck & Co.)
MSD (known as Merck & Co. in the U.S. and Canada) is a global biopharmaceutical leader committed to inventing for life. With a workforce of 63,000 employees across 65 countries, MSD focuses on delivering innovative health solutions, including personalized medicines, vaccines, and fertility treatments. The company empowers the scientific community through cutting-edge research tools, digital platforms, and a relentless pursuit of breakthroughs that improve and prolong lives.
Job Description: Manager, Regulatory Affairs – CMC
Key Responsibilities:
Regulatory Responsibilities:
- Develop and execute global regulatory strategies for CMC (Chemistry, Manufacturing, and Controls) submissions.
- Assess CMC changes, ensuring compliance with global regulatory requirements.
- Author and review regulatory documents for post-approval supplements, variations, annual reports, and renewals.
- Collaborate with manufacturing teams and external partners to ensure smooth change management.
- Identify regulatory risks and propose mitigation strategies.
- Communicate effectively with health authorities and internal stakeholders.
Technical Skills Required:
- Strong ability to analyze scientific data and assess regulatory compliance.
- Experience in pharmaceutical manufacturing, analytical testing, and quality assurance.
- Proficiency in electronic document management systems (GMP compliance).
- Excellent written and verbal communication skills.
Leadership Skills:
- Ability to lead cross-functional teams and manage multiple priorities.
- Strong problem-solving and decision-making capabilities.
- Adaptability to changing regulatory landscapes.
Qualifications & Experience:
- Education: Bachelor’s degree in Pharmacy, Chemical Engineering, Biology, Microbiology, or related fields (Master’s preferred).
- Experience: 5–7 years in the pharmaceutical industry, with at least 4 years in CMC regulatory submissions (small molecules, biologics, or vaccines).
- Location: Hyderabad or Pune (some travel may be required).
How to Apply?
Interested candidates can apply online before the deadline of 30th June 2025.
