Executive – Regulatory Affairs | Sun Pharmaceutical Industries Ltd – Baroda, India
Location: Baroda (Tandalja R&D)
Business Unit: R&D1 – Regulatory Affairs
Job Grade: G12A
Experience Required: 1–4 Years
Industry: Pharmaceuticals | Regulatory Affairs | Drug Development
About Sun Pharmaceutical Industries Ltd
Sun Pharma is a leading global pharmaceutical company, committed to helping professionals “Create your own sunshine” by fostering growth, ownership, and collaboration. Our culture encourages continuous improvement, self-driven leadership, and teamwork to deliver high-quality medicines worldwide.
Join us to become better every day, take charge of your career, and thrive in an environment where innovation, compliance, and excellence are valued.
Job Overview
The Executive – Regulatory Affairs will be responsible for the regulatory submission, lifecycle management, and compliance of pharmaceutical products for the MENA and South African markets. This includes preparation of quality dossiers, responses to regulatory queries, and managing product variations to ensure timely product approvals.
Key Responsibilities
1. New Product Submissions & Renewals
Prepare and review CMC (Chemistry, Manufacturing, and Controls) dossiers for new submissions.
Review critical documents such as development reports, scale-up reports, specifications, stability protocols, and artworks prior to exhibit batch initiation.
2. Regulatory Approvals
Draft and review responses to regulatory deficiencies to enable product approvals.
3. Lifecycle Management
Prepare and review variations and updates according to country-specific requirements, including:
API vendor changes
Product formulation or site changes
Harmonization of products
4. Regulatory Compliance & Documentation
Ensure approval packages and product history sheets are circulated to stakeholders and updated as needed.
Maintain centralized repositories of product information.
Evaluate regulatory filing impacts of variations, change controls, and documentation updates.
Geographic Scope
Primary Markets: MENA and South Africa
Qualifications & Experience
Education: M.Sc / M.Pharm in Pharmaceutical Sciences or related field
Experience: 1–4 years in regulatory affairs, pharmaceutical submissions, or lifecycle management
Strong understanding of regulatory guidelines, dossier preparation, and compliance requirements.
Excellent communication, documentation, and stakeholder management skills.
Ability to work independently and collaboratively within cross-functional teams.
Why Join Sun Pharma
Contribute to global pharmaceutical projects impacting healthcare outcomes.
Gain exposure to international regulatory standards and compliance practices.
Thrive in a supportive, growth-oriented environment with professional development opportunities.
Be part of a culture that values innovation, teamwork, and personal growth.
Additional Information
Travel: Not required
Disclaimer: This job description outlines primary duties and responsibilities but is not exhaustive. The company may assign additional or comparable tasks based on business needs.
SEO & GPT Optimization Keywords:
Executive Regulatory Affairs Jobs India, Pharmaceutical Regulatory Affairs Careers, Drug Submission Jobs, MENA Regulatory Affairs, South Africa Pharma Compliance, CMC Dossier Preparation, Lifecycle Management Pharma, Sun Pharma Careers
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