Sun Pharma Hiring Regulatory Affairs Executive

MSc, B Pharm — Regulatory Affairs Executive at Sun Pharma (Panoli)

M.Sc/B.Pharm candidates: 1 vacancy? Executive/Sr. Executive Regulatory Affairs at Sun Pharma, Panoli. 5–8 years experience required. Apply via email.

Sun Pharma’s Panoli facility in Bharuch, Gujarat is hiring an Executive / Sr. Executive — Regulatory Affairs. This role suits M.Sc or B.Pharm graduates with 5–8 years of regulatory experience who are comfortable preparing and submitting regulatory dossiers to multiple authorities. You’ll work at the intersection of compliance, product registration, and patient safety — ensuring medicines reach markets with full regulatory clarity.

Company Overview

Sun Pharmaceutical Industries Ltd (Sun Pharma) is one of India’s largest and most respected pharmaceutical companies, with a global presence across branded generics, specialty, and complex generics. The Panoli (Bharuch) facility focuses on sterile and non-sterile formulations and is part of Sun Pharma’s network of manufacturing sites that meet stringent quality and regulatory standards. Working here provides exposure to international regulatory submissions, multi-jurisdictional compliance, and well-established quality systems — all of which strengthen professional credibility and career growth in regulatory affairs.

Job Role & Responsibilities

What you’ll do (Executive / Sr. Executive — Regulatory Affairs)

• Prepare, compile and submit regulatory dossiers (CTD/eCTD and local formats) for product registrations and renewals across domestic and international regulatory authorities.
• Coordinate with cross-functional teams — R&D, Quality, Production, and Pharmacovigilance — to gather technical documentation, stability data, and batch records.
• Manage timelines and regulatory trackers for submissions, approvals, and post-approval commitments.
• Respond to regulatory queries and deficiency letters promptly and with technically sound responses.
• Support label/package insert changes, artwork approvals, and regulatory intelligence monitoring for changes in requirements.
• Ensure document control, versioning, and compliance with GMP/GDP and company SOPs.
• Assist in preparing dossiers for inspections and regulatory audits when required.

Day-to-day tasks

• Draft and review sections of CTD modules (Quality, Non-Clinical, Clinical summaries as applicable).
• Liaise with external regulatory consultants and contract research organizations (CROs) for specialized filings.
• Maintain up-to-date knowledge of regulatory guidelines (CDSCO, USFDA, EMA, ANVISA, WHO, etc.) and implement necessary changes.
• Maintain electronic and physical submission records, trackers and SOP compliance.

Eligibility / Qualifications

• Minimum qualification: M.Sc or B.Pharm. Candidates with a Master’s degree in Pharmaceutical Sciences, Regulatory Affairs, or related disciplines are preferred.
• Experience: 5–8 years in regulatory affairs within the pharmaceutical industry, with hands-on experience preparing CTD/eCTD dossiers and managing submissions.
• Technical skills: Strong knowledge of regulatory guidelines, dossier compilation, stability data interpretation, and document management systems.
• Soft skills: Excellent written communication for dossier writing and responses, strong coordination skills, ability to meet tight timelines, and attention to detail.

Location & Salary

• Location: Panoli, Bharuch, Gujarat.
• Work model: On-site at Panoli (as per operational requirement).
• Salary: Competitive and commensurate with experience; offered as per Sun Pharma’s remuneration policy. Specific CTC details were not provided in the HR brief.

Application Process

Interested candidates should email their CV to: priteshd.patel@sunpharma.com

Email subject line: Executive Regulatory Affairs

Make sure your CV highlights relevant dossier experience (CTD/eCTD), products handled, key approvals or filings you contributed to, and any international submission exposure.

How to prepare a strong application (quick checklist)

• Tailor your CV to regulatory dossier experience: list CTD modules you compiled, countries filed, and specific product types (sterile injectables, oral solids, etc.).
• Include measurable outcomes: approvals granted, reduction in review cycles, number of dossiers managed, or regulatory queries closed.
• Attach a short cover note (2–3 lines) in the email summarizing your core regulatory strengths and availability.
• Mention your willingness to relocate or work on-site in Panoli if required.

High-value keywords included naturally

Regulatory affairs jobs, CTD dossier preparation, eCTD submissions, regulatory compliance, pharmaceutical regulatory affairs, drug regulatory submission, dossier writing, pharmaceutical quality systems, drug approval process, regulatory intelligence.

FAQs

Q: What is the minimum experience required?
A: 5 years is the minimum for the Executive / Sr. Executive role; the HR brief specifies 5–8 years.

Q: What qualifications are accepted?
A: M.Sc or B.Pharm are stated qualifications. Candidates with postgraduate credentials in regulatory affairs or pharmaceutical sciences will have an advantage.

Q: Is remote or hybrid work allowed?
A: The role is based at Panoli, Bharuch. On-site presence is expected due to the nature of regulatory coordination with manufacturing and quality teams.

Q: Should I include my eCTD software skills on the CV?
A: Yes. Mention experience with eCTD publishing tools, document management systems, and regulatory trackers.

Q: How do I format the subject line?
A: Use: Executive Regulatory Affairs as the subject line when emailing your CV to ensure correct routing.

Q: Are freshers eligible?
A: No. This opening requires 5–8 years of relevant regulatory experience.

---

Category	Details
Company	Sun Pharmaceutical Industries Ltd (Panoli, Bharuch)
Vacancies	Executive / Sr. Executive – Regulatory Affairs
Required Education	M.Sc, B.Pharm, M.Pharm Regulatory Affairs, Postgraduate Diploma in Regulatory Affairs, B.Sc Chemistry, B.Sc Biotechnology, M.Sc Biochemistry
Experience	5–8 years