Merck Hiring Specialist – Regulatory Affairs

Merck Hiring Specialist – Regulatory Affairs in Mumbai

Merck has announced a new hiring opportunity for the position of Specialist – Regulatory Affairs at its Mumbai location. The company is inviting applications from experienced pharmacy, biotechnology, chemistry, and life sciences professionals for regulatory affairs and compliance operations within pharmaceutical and biopharmaceutical sectors.

This recruitment drive is attracting candidates searching for regulatory affairs jobs in Mumbai, pharmaceutical compliance careers, CDSCO regulatory specialist openings, pharma regulatory affairs manager jobs, API regulatory submission careers, biopharma compliance jobs, healthcare regulatory consulting opportunities, and pharmaceutical market access roles.

Candidates with strong regulatory submission experience, compliance documentation expertise, product registration knowledge, and understanding of Indian and global pharmaceutical regulations can apply for this opportunity.

Company Overview

Merck is a global science and technology company operating across healthcare, life sciences, and electronics sectors. The company focuses on innovation-driven solutions that support pharmaceutical manufacturing, biotechnology research, healthcare development, and scientific advancement worldwide.

The organization works extensively in regulatory compliance, healthcare product development, pharmaceutical manufacturing support, life sciences operations, and biopharma innovation. Merck continues to strengthen its regulatory and compliance workforce to support global healthcare operations and regulatory excellence.

Regulatory affairs and pharmaceutical compliance sectors continue to generate strong demand for skilled professionals due to increasing global regulatory standards, pharmaceutical product registrations, import compliance requirements, and healthcare quality regulations.

Mumbai remains one of India’s largest pharmaceutical and regulatory operations hubs, creating significant career opportunities in healthcare compliance, biopharma regulation, pharmaceutical consulting, market access strategy, and regulatory documentation management.

Job Role & Responsibilities

Specialist – Regulatory Affairs Responsibilities

Candidates selected for this role will support regulatory compliance, advocacy, and pharmaceutical market access activities.

Key responsibilities include:

• Monitoring and analyzing regulatory guidelines, notifications, and gazettes
• Assessing the impact of regulatory updates on business operations
• Coordinating with regulatory authorities including CDSCO, IPC, DBT, DAHD, BIS, AQCS, and DCPC
• Supporting regulatory advocacy through industry association participation
• Preparing and supporting regulatory submissions and compliance documentation
• Handling import licenses, test licenses, and NOCs for APIs and excipients
• Supporting regulatory audits and inspection readiness activities
• Assisting product registrations and market access processes
• Determining regulatory pathways for new product launches
• Supporting product classification and compliance evaluation
• Coordinating cross-functional documentation and regulatory query responses
• Maintaining WHO-GMP, GLP, and Schedule M compliance requirements
• Developing and maintaining SOPs for regulatory functions
• Supporting technical and regulatory communication with internal stakeholders and customers
• Representing Indian regulatory priorities in global regulatory meetings

Skills Required

Candidates should possess:

• Strong regulatory affairs knowledge
• Regulatory submission and documentation expertise
• Understanding of Indian and global pharmaceutical regulations
• Regulatory compliance and audit management skills
• Product registration and import documentation knowledge
• SOP development and maintenance capabilities
• Communication and stakeholder management skills
• Cross-functional coordination abilities
• Analytical and problem-solving skills
• Ability to manage multiple regulatory priorities

Candidates with exposure to pharmaceutical manufacturing, biopharma operations, API regulation, excipient compliance, healthcare market access, and regulatory advocacy will have an advantage.

Eligibility / Qualifications

Educational Qualification

Candidates with pharmacy, biotechnology, chemistry, and life sciences educational backgrounds are eligible.

Relevant educational qualifications include:

M.Pharm, B.Pharm, MSc Chemistry, MSc Biotechnology, Life Sciences, Pharmaceutical Sciences, Regulatory Affairs, Biopharmaceutical Sciences.

Experience Requirement

• Experience in regulatory affairs and compliance operations preferred
• Regulatory submission and audit handling experience preferred
• Experience with product registration and import-related activities preferred
• Regulatory authority interaction experience preferred
• Pharmaceutical and biopharma manufacturing exposure preferred

These openings are suitable for:

• Regulatory affairs specialists
• Pharmaceutical compliance professionals
• API regulatory associates
• Healthcare regulatory consultants
• Biopharma compliance professionals
• Product registration specialists
• Pharmaceutical documentation experts
• Market access and regulatory operations candidates

Location & Salary

Location

Mumbai, Maharashtra

Estimated Salary

₹8 LPA – ₹16 LPA approximately

Salary may vary depending on regulatory affairs expertise, pharmaceutical compliance exposure, audit handling experience, and global regulatory knowledge.

Application Process

Interested candidates can apply through the official Merck careers portal.

Apply Online

https://careers.merckgroup.com/global/en/job/299425/Specialist-Regulatory-Affairs

Job ID

299425

Travel Requirement

Domestic travel up to 10–15%

Frequently Asked Questions (FAQs)

1. What position is Merck hiring for in Mumbai?

Merck is hiring for the role of Specialist – Regulatory Affairs.

2. Which qualifications are eligible for this pharmaceutical regulatory role?

Candidates with M.Pharm, B.Pharm, Biotechnology, Chemistry, and Life Sciences qualifications can apply.

3. What regulatory skills are preferred for this opportunity?

Experience in CDSCO compliance, regulatory submissions, product registration, audit handling, SOP management, and import documentation is preferred.

4. What is the estimated salary for Specialist – Regulatory Affairs roles?

The expected salary range is approximately ₹8 LPA to ₹16 LPA depending on regulatory expertise and pharmaceutical industry exposure.

5. What is the work location for this opportunity?

The work location is Mumbai, Maharashtra.

6. How can candidates apply for Merck recruitment?

Candidates can apply through the official Merck careers portal.

Summary Table

Company	Merck
Department Vacancies	Specialist – Regulatory Affairs
Qualification	M.Pharm, B.Pharm, MSc Chemistry, Biotechnology, Life Sciences
Experience	Regulatory Affairs & Compliance Experience Preferred
Location	Mumbai, Maharashtra

Tagged as: Pharma Jobs in Mumbai