Executive, Regulatory Affairs
Executive, Regulatory Affairs
Sun Pharma
Job description
Looking to build a career in DMF submissions and regulatory affairs? Explore this Executive, Regulatory Affairs role at Sun Pharma in Panoli.
Company Description
Sun Pharmaceutical Industries Ltd is a global pharmaceutical company that focuses on helping employees develop at every stage of their career. The company creates a culture about improving every day being confident and doing well as a team. Sun Pharma encourages ideas, good quality and constant improvement making a place where workers can create strong and satisfying jobs.
Job Summary
This role sits within the R&D1 Regulatory Affairs team, based in Panoli. As an Executive, you will review and maintain GMP documents while coordinating quality management system activities. Your work will include preparing and compiling data for USDMF, CEP, DCP, and CP submissions across global markets. The role also involves coordinating with plant and corporate regulatory teams to meet submission timelines.
Key Responsibilities
Review and maintain GMP documents accurately and on time.
Coordinate QMS related activities, including change control processes.
Approve documents such as SOPs and STPs as required.
Review, follow up, and compile data for USDMF, CEP, DCP, and CP submissions.
Support new DMF submissions and DMF amendments or updates for Corporate RA, Mumbai.
Support USDMF and DMF amendment submissions for Corporate RA, Gurgaon.
Review and compile submission data for Japan, China, TGA, and Canadian authorities.
Compile raw data for registration and re registration across ROW markets, such as China, Korea, Taiwan, Indonesia, and South Africa.
Respond to regulatory queries received from authorities in different markets.
Coordinate and organize the plant regulatory team based on planning and timelines.
Educational Qualification
M.Pharm or M.Sc degree.
Skills Required
4 to 6 years of relevant experience in regulatory affairs.
Strong knowledge of GMP documentation and quality management systems.
Good understanding of DMF submissions and global regulatory requirements.
Strong data compilation and documentation skills.
Good coordination skills to work with plant and corporate teams.
Ability to manage multiple submissions and deadlines across markets.
Salary Structure
An Executive in Regulatory Affairs at Sun Pharmaceutical Industries earns an average annual salary ranging from ₹4.9 Lakhs to ₹7.2 Lakhs in India.
Career Development
This role offers hands on experience in global regulatory submissions within a leading pharmaceutical company. Sun Pharma also supports long term growth through strong benefits and opportunities for both personal and professional development.
How to Apply
Visit our job portal and search for the Executive, Regulatory Affairs role - Sun Pharma.
Click on the job posting to read all the details, about the job.
Fill in your details. Upload your updated resume.
Send your application.
Education
Postgraduate Degree (Master's/PhD)
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.