Executive – Regulatory Affairs
Baroda, India
Sun Pharmaceutical Industries Ltd. is seeking a highly motivated and detail-oriented Executive – Regulatory Affairs to join our dynamic R&D team in Baroda. In this role, you will be responsible for supporting regulatory activities related to CMC dossier preparation, lifecycle management, and regulatory submissions for the MENA markets. If you have a strong understanding of regulatory compliance, a passion for drug development, and experience navigating GCC regulatory frameworks, we encourage you to apply.
Job Summary
The Executive – Regulatory Affairs will contribute to the preparation, review, and submission of regulatory documents for pharmaceutical products in the MENA region. This position requires a strong understanding of CMC (Chemistry, Manufacturing, and Controls) requirements, as well as experience in managing product lifecycles through variations and other regulatory processes. The ideal candidate will be a team player with excellent communication and problem-solving skills, capable of working independently and collaboratively to meet regulatory deadlines.
Responsibilities
- New Submissions & Renewals:
- Review and prepare CMC dossiers for submission to regulatory agencies in the MENA region.
- Assess scale-up processes, stability protocols, product labels, specifications, and other relevant documents prior to the initiation of exhibit batches.
- Regulatory Approvals:
- Prepare and respond to deficiency letters and address agency queries to facilitate timely product approvals.
- Lifecycle Management:
- Prepare and review variations for activities such as:
- API vendor changes
- Test method updates
- Manufacturing site transfers
- Harmonization activities
- Prepare and review variations for activities such as:
- Regulatory Compliance:
- Maintain product history sheets and approval databases to ensure accurate record-keeping.
- Conduct regulatory impact assessments for change controls and develop variation plans as needed.
- Maintain and update the centralized document repository to ensure easy access to critical information.
- Market Exposure:
- Gain experience with the regulatory requirements of various MENA countries, including Saudi Arabia, UAE, Oman, Egypt, Bahrain, Iraq, Iran, Qatar, and Kuwait, as well as the GCC (Gulf Cooperation Council) authorities.
Requirements
- Education: M.Pharm or M.Sc degree in Pharmaceutical Sciences, Regulatory Affairs preferred.
- Experience: 1–4 years of relevant experience in Regulatory Affairs within the pharmaceutical industry.
- Core Skills:
- Proficiency in CMC dossier authoring and review.
- Experience in preparing and submitting regulatory variations.
- Strong knowledge of CMC requirements for pharmaceutical products.
- Ability to effectively handle and respond to regulatory queries.
- Familiarity with regulatory guidelines and requirements in the MENA region.
- Excellent written and verbal communication skills.
- Strong attention to detail and organizational skills.
- Ability to work independently and as part of a team.
Benefits
Sun Pharma is committed to providing a supportive and rewarding work environment for its employees. Benefits include:
- Career advancement opportunities and internal mobility within the company.
- Exposure to global regulatory markets and diverse regulatory environments.
- Access to mentorship programs and ongoing learning and development opportunities.
- Initiatives promoting work-life balance and employee wellness.
- Competitive salary and benefits package.
How to Apply
If you meet the qualifications and are interested in joining our team, we encourage you to apply. Please submit your resume and a cover letter highlighting your relevant experience and skills.