Executive Regulatory Affairs Vacancy | Sun Pharma Tandalja
Apply for Executive Regulatory Affairs role at Sun Pharma Tandalja. Open for Life Science graduates in regulatory submissions and labeling.
Sun Pharmaceutical Industries Ltd, a global leader in innovative pharmaceuticals, is seeking an Executive – Regulatory Affairs at its Tandalja R&D facility. This role is ideal for professionals with expertise in regulatory submissions, labeling compliance, and USFDA guidelines, contributing to the safe and timely launch of pharmaceutical products.
Company Overview
Sun Pharma is one of the largest and most trusted pharmaceutical companies in the world, renowned for its commitment to innovation, quality, and regulatory excellence. With a diverse portfolio of generic and specialty medicines, Sun Pharma focuses on improving patient lives globally. The company fosters a collaborative environment where regulatory professionals can advance their careers while ensuring the highest standards of compliance.
Job Role & Responsibilities
As an Executive in Regulatory Affairs, your key responsibilities will include:
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
a. 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.
b. Preparation/review and submission of good quality dossiers thereby enabling faster approvals and
timely launch
c. Preparation and submission of meeting packages/scientific discussion with Agency related to product
development
d. 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 products
a. Timely preparation and submission of annual reports/renewals
b. Evaluation, preparation and submission of changes through variations, supplements etc that impact
product supplies
c. Regulatory Compliance – Ensure timely implementation of regulatory decisions for change
management and other activities in DF plants
d. Ensure reposition of comprehensive product information into central repository
4. Self Development
a. Awareness of regulatory guidelines, participating and delivering presentations
Eligibility / Qualifications
- Education: M. Pharm
- Experience: 2-5 years Relevant experience in regulatory affairs,
- Technical Skills:
- Knowledge of USFDA labeling requirements and ANDA/NDA processes.
- Proficiency in SPL creation and regulatory submission software.
- Strong coordination, communication, and documentation skills.
- Desirable: Experience coordinating with cross-functional teams and managing REMS requirements.
Relevant courses include: BPharm, MPharm, MSc Biotechnology, MSc Life Sciences, Regulatory Affairs Certification.
Location & Salary
- Location: Tandalja, Vadodara, Gujarat, India.
- Work Type: Full-time, on-site.
- Salary: Competitive, aligned with industry standards, including benefits and career growth opportunities.
Application Process
Interested candidates are encouraged to apply early to secure their spot. Sun Pharma maintains a transparent and inclusive recruitment process.
FAQs
1. Who can apply for this role?
Candidates with a degree in Pharmacy, Life Sciences, or Biotechnology, with experience in regulatory affairs, labeling, or USFDA submissions.
2. What are the key responsibilities?
Preparation, review, and submission of drug labeling, coordination with cross-functional teams, and managing REMS requirements.
3. Where is the position based?
The role is located at Tandalja, Vadodara, Gujarat, India.
4. Is prior USFDA experience necessary?
Yes, familiarity with ANDA/NDA labeling requirements is essential.
5. How can I apply?
Submit your application through the official Sun Pharma careers portal link provided above.
Job Summary Table
| Category | Details |
|---|---|
| Company | Sun Pharmaceutical Industries Ltd |
| Vacancies | Executive – Regulatory Affairs |
| Required Education | BPharm, MPharm, MSc Biotechnology, MSc Life Sciences, Regulatory Affairs Certification |
| Experience | Relevant experience in regulatory affairs, labeling, or USFDA submissions |
| Location | Tandalja, Vadodara, Gujarat, India |
