Job Opening: Regulatory Affairs Specialist at Hetero – Apply Now
Hetero is actively hiring for the position of Regulatory Affairs Specialist at its Jeedimetla, Hyderabad location.
This opening is for experienced professionals with 3 to 9 years in Regulatory Affairs, especially in formulation markets across ROW, EU, and the US.
If you’re looking for a role that offers stability, regulatory exposure, and a structured pharma career path, this is a solid opportunity.
About the Role – Regulatory Affairs Specialist
The RA Specialist role at Hetero focuses on formulation dossiers and lifecycle documentation for major regulated markets.
You will work closely with cross-functional teams to ensure:
Proper submission of regulatory documents
Lifecycle updates
Market-specific compliance
The role supports Marketing Authorization Applications (MAA) and demands attention to detail in pre-approval and post-approval activities.
You’ll play a key part in ensuring global product compliance and regulatory success.
Key Responsibilities and Skills Required
Key responsibilities include:
Dossier preparation, review, and submission
Expertise in Life Cycle Management
Experience in pre-approval and post-approval handling
Working knowledge of MAA (Marketing Authorization Application)
Familiarity with CMC (Chemistry, Manufacturing, and Controls) sections
Candidates must be able to:
Coordinate with technical teams and regulatory bodies
Understand market-specific requirements
Manage documentation within strict timelines
Strong written communication and organizational skills are essential.
Eligibility Criteria
Experience: 3 to 9 Years
Education: M.Pharm, B.Pharm, or M.Sc
Applicants with experience in formulation regulatory filings for US, EU, and ROW markets will be preferred.
Understanding current regulatory guidelines and strong documentation practices is critical.
Work Location and Application Details
Work Location:
Jeedimetla, Hyderabad
Application Process:
Interested candidates should email their CV to:
Subject Line:
“Application for RA”
Include your updated CV with:
Experience summary
Regulatory submissions handled
Market expertise (ROW/EU/US)
Educational credentials
Apply soon to avoid missing this career opportunity.
Why Choose Hetero for Your RA Career?
Hetero is one of India’s largest and most respected pharmaceutical manufacturers. With a global presence in over 125 countries, Hetero provides:
A chance to work on international regulatory projects
Exposure to major markets like USFDA, EMA, and ROW
A structured work environment with defined career growth
Competitive compensation and learning support
The RA role at Hetero offers unmatched exposure to global pharma operations. This is ideal for professionals serious about building their careers in regulatory affairs.
