Sun Pharma Hiring Executive – Regulatory Affairs
- About Sun Pharmaceutical Industries Ltd
- Current Openings
- Accepted Education Background & Related Courses
- Key Responsibilities
- Desired Skills & Competencies
- 📩 How to Apply
- Company & Job Summary Table
Executive – Regulatory Affairs Opening at Sun Pharma, Tandalja R&D | B Pharm/M.Pharm with 2+ Years of Experience
Explore exciting opportunities in Regulatory Affairs at Sun Pharmaceutical Industries Ltd, located in Tandalja, Vadodara. This position is ideal for B Pharm/M.Pharm graduates with a minimum of 2 years’ experience in labeling and regulatory submissions for USFDA-regulated markets.
| ob Title: | Executive – Regulatory and Business Continuity | Business Unit: | R&D1 Regulatory Affairs | ||
| Job Grade | G12A | Location : | Baroda | ||
About Sun Pharmaceutical Industries Ltd
Sun Pharma is a global leader in specialty generics and branded pharmaceuticals, serving over 100 markets worldwide. With a focus on innovation, compliance, and operational excellence, Sun offers a collaborative environment for pharmaceutical professionals.
Current Openings
Position: Executive – Regulatory Affairs
- Location: Tandalja – R&D, Vadodara, Gujarat
- Department: Regulatory Affairs – US Market
- Required Education: B Pharm / M.Pharm
- Experience: Minimum 2 years in Regulatory Affairs / Labeling functions
Accepted Education Background & Related Courses
Eligible Qualifications:
- B Pharm
- M.Pharm (Pharmaceutical Sciences, Regulatory Affairs, Pharmaceutics)
Relevant Courses:
- USFDA Drug Approval Process
- Labeling & Structured Product Labeling (SPL)
- ANDA/NDA Regulatory Submissions
- REMS Documentation and Implementation
- Pharmaceutical Regulatory Affairs Certification
Key Responsibilities
- New Submissions: Work with Product Development (For Drug products) & other CFT (within and outside R&D) to ensure that sufficient and timely regulatory information and controls are included during design and development of drug products as per country specific regulatory requirements
- Provide feedback in terms of document requirements & regulatory filing strategy during development of new DF (Drug Formulation). Review and approve documents on behalf of regulatory.
- Preparation/review and submission of good quality dossiers thereby enabling faster approvals and timely launch
- Preparation and submission of meeting packages/scientific discussion with Agency related to product development
- Anticipate expected deficiencies and prepare mitigation plans
2. Approval: Prepare and submit timely response to deficiencies enabling approval of products.
3. Lifecycle Management for approved drug product
- Timely preparation and submission of annual reports/renewals
- Evaluation, preparation and submission of changes through variations, supplements etc that impact product supplies
- Regulatory Compliance – Ensure timely implementation of regulatory decisions for change management and other activities in DF plants
- Ensure reposition of comprehensive product information into central repository
4. Self Development
a. Awareness of regulatory guidelines, participating and delivering presentations
Desired Skills & Competencies
- Knowledge of FDA regulations and labeling compliance
- Experience in SPL generation and REMS documentation
- Proficiency in regulatory software and artwork tracking tools
- Effective cross-functional communication and coordination
- Strong analytical and problem-solving abilities
📩 How to Apply
Click below to apply via Sun Pharma’s official careers portal:
👉 Apply Now
🗓️ Apply before the vacancy closes.
Company & Job Summary Table
| Company Name | Current Vacancies in Departments | Required Education | Experience Required |
|---|---|---|---|
| Sun Pharmaceutical Ltd | Regulatory Affairs – US Labeling | B Pharm / M.Pharm | Minimum 2 years |
Accelerate your regulatory career with India’s top pharma company. Apply today and be part of Sun Pharma’s global success story.
To apply for this job please visit careers.sunpharma.com.
