Are you looking for an exciting career in the pharmaceutical industry? Sun Pharma, India’s No. 1 company in the pharmaceutical sector, is offering an excellent opportunity for skilled professionals to join their team. If you are passionate about regulatory affairs and have the expertise to navigate India’s regulatory landscape, the position of India Regulatory Affairs Manager could be your next big career move. Read on to learn more about this job, its responsibilities, qualifications, and how to apply
Job Details: India Regulatory Affairs Manager
Post Name: Manager – India Regulatory Affairs (IRA)
Department: India Regulatory Affairs
Location: Tandalja, Gujarat
Experience Required: 5–10 Years
Qualification: M.Pharm
Industry Type: Pharma/Healthcare/Clinical Research
Functional Area: Regulatory Affairs
Application Deadline: 31st March 2025
Key Responsibilities of an India Regulatory Affairs Manager
As an India Regulatory Affairs Manager at Sun Pharma, you will play a pivotal role in ensuring compliance with regulatory requirements for pharmaceutical products and medical devices in India. Below is a detailed list of responsibilities:
- Regulatory Strategy Evaluation: Develop and evaluate regulatory strategies for product registration in India.
- Application Submission: Handle submissions for domestic manufacturing and marketing permissions via online portals, ensuring compliance with the Drugs Controller General of India (DCGI) guidelines.
- Import Registration: Manage applications for import registration and licenses for drugs and medical devices.
- Document Coordination: Review and finalize documents required for regulatory submissions, coordinating with internal teams for accuracy and completeness.
- Bioequivalence (BE) Permissions: Evaluate and submit applications for BE permissions for export registration.
- Test and Analysis Permissions: Handle applications for permissions to manufacture or import drugs and medical devices for examination, testing, or analysis (Forms CT-10/12/13, Form-11, Form CT-17, MD-16).
- Regulatory Notifications: Review draft gazette notifications related to regulatory changes and provide expert comments.
- Market Complaint Resolution: Evaluate and respond to market complaints raised by regulatory authorities in a timely manner.
This role requires a deep understanding of India’s regulatory framework, attention to detail, and the ability to collaborate effectively with cross-functional teams.
Qualifications and Skills Required
To excel in this role, candidates must meet the following criteria:
- Educational Qualification: M.Pharm from a recognized institution.
- Experience: 5–10 years of relevant experience in regulatory affairs within the pharmaceutical, healthcare, or clinical research industry.
- Technical Skills: Proficiency in navigating online regulatory portals, preparing submission dossiers, and interpreting regulatory guidelines.
- Soft Skills: Strong analytical skills, attention to detail, excellent communication, and the ability to work under tight deadlines.
Prior experience with DCGI submissions, import licensing, and regulatory compliance will be an added advantage.
How to Apply for This Job
If you meet the qualifications and are excited about this opportunity, don’t miss the chance to apply! Follow these steps:
- Prepare an updated resume highlighting your experience in regulatory affairs.
- Visit the official Sun Pharma careers page or trusted job portals like PharmaBharat.org to submit your application.
- Ensure your application is submitted before the deadline: 31st March 2025.
