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Sun Pharma
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:
- Preparing and reviewing labeling for ANDA and NDA applications and responding to labeling queries in compliance with USFDA regulations.
- Preparing Structured Product Labeling (SPL) for drug listing in line with applications and regulatory requirements.
- Timely submission and coordination of labeling updates based on FDA notifications and reference-listed drug (RLD) updates.
- Coordinating labeling activities with cross-functional teams to ensure timely product launches.
- Handling regulatory submissions, final labeling implementation, and maintaining labeling artworks using various software tools.
- Communicating with third parties or private label distributors to gather requirements for labeling development.
- Evaluating and coordinating with departments for Risk Evaluation and Mitigation Strategies (REMS) requirements.
Eligibility / Qualifications
- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related disciplines.
- Experience: Relevant experience in regulatory affairs, labeling, or USFDA submissions.
- 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 |
To apply for this job please visit careers.sunpharma.com.