Marksans Pharma Hiring FDA Licensing Specialist

Marksans Pharma Ltd; Poriebhat; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Marksans Pharma Pvt. Ltd. in Verna, Goa seeks an FDA Licensing Specialist with 3–6 years of regulatory experience. The role focuses on preparing, submitting, and managing drug licensing applications under Goa FDA and CDSCO guidelines.

The successful candidate will liaise with R&D, QA, and manufacturing to gather necessary data and respond promptly to regulatory queries, ensuring strict compliance and thorough documentation.

Qualifications

• 3–6 years of regulatory experience in pharma.
• Experience with licensing submissions and approvals.
• Familiarity with Goa FDA and CDSCO processes.
• Background in B Pharm / M.Pharm / MSc is required.

Responsibilities

• Prepare and submit product licensing applications.
• Coordinate with R&D, QA, QC, and manufacturing for data and documentation.
• Manage and respond to FDA/CDSCO queries and deficiency letters.
• Maintain up-to-date licensing documentation and databases.
• Assist in licensing renewals and amendments.

Skills

Regulatory affairs

Documentation management

Liaison with regulatory bodies

Attention to detail

Education

B Pharm

M.Pharm

MSc (Life Sciences / Chemistry)

Tools

Sugam portal

NSWS portal

CDSCO portal

Job description

FDA Licensing Specialist Job in Goa for B Pharm/M.Pharm/MSc – Marksans Pharma

Apply for FDA Licensing Specialist at Marksans Pharma in Verna, Goa. Suitable for B Pharm, M.Pharm, MSc graduates with 3–6 years experience. Preference for Goan candidates.

Join Marksans Pharma – Hiring FDA Licensing Specialist in Goa

If you are a regulatory professional seeking growth in the pharmaceutical industry, here’s your chance to join a USFDA-approved pharma company. Marksans Pharma Pvt. Ltd. is urgently hiring for the role of FDA Licensing Specialist at its manufacturing facility in Verna, Goa.

This opportunity is perfect for candidates with 3 to 6 years of regulatory experience and a background in B Pharm, M.Pharm, or MSc. If you’re experienced in handling licensing processes through Sugam and NSWS portals and want to work in a compliance-driven environment, this role is tailor-made for you.

About Marksans Pharma Pvt. Ltd.

Marksans Pharma is a reputed name in the pharmaceutical sector, recognized globally for its high-quality and affordable generics. With operations spanning multiple continents and a robust regulatory track record (including USFDA, MHRA, and TGA approvals), Marksans provides an ideal work environment for career progression.

Key Responsibilities

• Prepare, compile, and submit product applications.
• To obtain product licenses, plant changes permissions, test license, mfg lic, Import license, export noc and other licensing approvals from Goa FDA and CDSCO
• Coordinate with R&D, QA, QC, manufacturing to gather documentation and data required for regulatory submissions.
• Manage and respond to FDA and CDSCO queries, deficiency letters etc.
• Maintain up-to-date licensing documentation and licensing databases.
• Hands-on experience in Sugam portal and NSWS portal is required.

Required Qualifications

• Educational Background: B Pharm / M.Pharm / MSc (Life Sciences / Chemistry)
• Experience: 3 to 6 years in a pharmaceutical regulatory role
• Location Preference: Candidates from Goa will be preferred

Why Join Marksans Pharma?

• Competitive salary package
• Opportunity to work in a USFDA-approved manufacturing setup
• Exposure to international regulatory practices
• Strong emphasis on compliance, quality, and documentation