Urgent Hiring: Regulatory Affairs Officer – Marksans Pharma | 5–8 Years Experience | Verna, Goa

Apply now for a Regulatory Affairs Officer role at Marksans Pharma, Goa. 5–8 years of experience required. B.Pharm/M.Pharm preferred. Full-time position.

🚨 Urgent Hiring: Regulatory Affairs Officer at Marksans Pharma – Goa 🚨

Are you an experienced professional in the pharmaceutical regulatory domain seeking a strategic role with a global pharma company? Here’s your opportunity to join Marksans Pharma Ltd., a rapidly expanding pharmaceutical giant, as a Regulatory Affairs Officer in Verna, Goa.

This is your chance to apply your expertise in drug regulatory compliance, dossier preparation, FDA/EMA submissions, and international product registrations. With over 5–8 years of industry experience, this role is ideal for professionals who want to advance their regulatory affairs career in India’s growing pharma sector.

📍 Job Location:

Marksans Pharma Pvt Ltd
Verna Industrial Estate,
Verna – Goa, India.

💼 Job Title:

Regulatory Affairs Officer – Pharma Industry

🕒 Employment Type: Full-time | Permanent Position

🎓 Qualifications Required:

• Bachelor of Pharmacy (B.Pharm)

• Master of Pharmacy (M.Pharm) – Regulatory Affairs / Pharmaceutics preferred

👤 Experience:

5 to 8 years of hands-on experience in regulatory affairs within the pharmaceutical industry

📌 Key Responsibilities:

1. Dossier Preparation and Submission

   • Prepare, review, and compile regulatory submissions including CTD/eCTD dossiers.

   • Submit documents to regulatory authorities such as USFDA, EMA, MHRA, TGA, WHO, and other international agencies.

2. Regulatory Compliance

   • Ensure all submissions are compliant with ICH guidelines, regional regulatory requirements, and company SOPs.

   • Stay updated with global regulatory standards and changing guidelines from agencies like the FDA, EMA, CDSCO, etc.

3. Product Registrations and Renewals

   • Coordinate with internal departments for new product registrations, post-approval variations, and license renewals.

   • Manage responses to regulatory queries during ANDA/NDA/MAA review cycles.

4. Communication and Coordination

   • Liaise effectively with regulatory agencies, contract manufacturers, and third-party vendors.

   • Collaborate with cross-functional teams like R&D, QA, QC, Production, and Supply Chain.

5. Regulatory Documentation

   • Maintain regulatory master files, product registration databases, labeling records, and compliance reports.

   • Assist with writing regulatory strategies for new market entries and regulatory intelligence analysis.

6. Change Control and Risk Assessment

   • Evaluate changes for regulatory impact and coordinate submissions for CMC changes, labeling updates, and packaging alterations.

💰 Salary & Perks:

• Competitive compensation based on experience

• Performance-based incentives

• Annual bonus

• Provident Fund (PF), Gratuity, Health Insurance

• Professional development and training support

📈 This is a high-potential role for professionals in regulatory affairs who aim to grow into Regulatory Managers, Global Submission Leads, or Compliance Directors in the pharmaceutical industry.

📞 Contact Details:

📱 Phone: 7447488738 / 9607909654
📧 Email:

• saloni.pattanshetty@marksanspharma.com

• ajit.sambare@marksanspharma.com

✉️ How to Apply:

Send your updated resume along with supporting documents to the email addresses mentioned above. Mention “Regulatory Affairs Officer – Goa” in the subject line.

✅ Shortlisted candidates will be contacted for a face-to-face or virtual interview.

🌍 About Marksans Pharma Ltd:

Marksans Pharma is a globally recognized pharmaceutical company with a strong presence in regulated markets such as the US, Europe, Australia, and emerging markets. Known for its strong R&D, high-quality manufacturing, and robust compliance systems, Marksans specializes in oral solid dosage forms and has extensive experience in regulated market submissions.

Headquartered in Mumbai, with manufacturing facilities in Goa and the UK, Marksans offers a collaborative environment for professionals who aim to deliver high-quality and compliant pharmaceutical products to global markets.

🌟 Why This Job Is Ideal for You:

• Work with global health authorities like FDA, EMA, and TGA

• Get hands-on experience with dossier compilation, submission, and lifecycle management

• Join a company with strong regulatory history and expanding market share

• Advance your career in a high-growth, high-demand profession

• Contribute to international drug approval processes and market expansion strategies.

If you’re looking to boost your career in regulatory affairs, this opportunity at Marksans Pharma, Goa, is perfect for you. With attractive pay, career growth, international exposure, and the chance to work on global drug submissions, this role offers everything a seasoned regulatory professional seeks.

📌 Don’t wait! Apply now and be a part of India’s fast-growing pharma success story.