Intas Biopharma Hiring Regulatory Affairs Executive/Sr Executive

M.Pharm Regulatory Affairs Jobs – Intas Ahmedabad

Intas Biopharma hiring Regulatory Affairs Executive/Sr Executive in Ahmedabad. M.Pharm/M.Sc Biotech with 2–10 years experience.

Intas Pharmaceuticals Ltd. is expanding its biopharmaceutical operations and is inviting experienced regulatory professionals to join its growing Regulatory Affairs team at the Ahmedabad biopharma plant. This opportunity is aimed at professionals with hands-on experience in global regulatory submissions, particularly within biosimilars and regulated markets. The role offers direct involvement in high-impact regulatory activities that support global product approvals and lifecycle management.

This position is ideal for candidates seeking long-term growth in regulatory affairs, exposure to USFDA, EU, and emerging market submissions, and the opportunity to contribute to complex biopharmaceutical development programs within a globally respected pharmaceutical organization.

Company Overview

Intas Pharmaceuticals Ltd. is one of India’s leading multinational pharmaceutical companies with a strong presence across formulations, biologics, and biosimilars. The company operates globally with approvals in highly regulated markets, including the US, EU, and other international regions.

Intas Biopharma is at the forefront of biosimilar development and commercialization, supported by advanced R&D infrastructure, regulatory expertise, and global compliance systems. Careers at Intas offer professionals exposure to international regulatory environments, structured career progression, and meaningful contributions to global healthcare advancement.

Job Role & Responsibilities

Regulatory Affairs – Executive / Senior Executive

Key Responsibilities:

• Authoring, reviewing, and coordinating regulatory dossiers for global submissions
• Managing submissions to USFDA, EMA, and other regulated and emerging markets
• Reviewing source documents, data packages, and submission inputs for MAAs and variations
• Providing regulatory guidance during early and late stages of product development
• Ensuring timely submission of Marketing Authorization Applications (MAAs)
• Coordinating with cross-functional teams and subject matter experts to address health authority queries
• Managing post-approval lifecycle activities and regulatory commitments
• Maintaining regulatory tracking systems for submissions and queries
• Ensuring high-quality, compliant regulatory deliverables

Eligibility / Qualifications

Educational Qualification:
M.Pharm, M.Sc (Biotechnology), M.Tech (Biotechnology)

Relevant Courses Accepted:
M.Pharm (Regulatory Affairs, Pharmaceutics, Pharmaceutical Biotechnology), M.Sc Biotechnology, M.Tech Biotechnology

Experience Requirement:
2 to 10 years of experience in Regulatory Affairs

Preferred Experience:

• Biosimilars Regulatory Affairs
• Exposure to USFDA, EMA, and global submissions

Location & Salary

Job Location: Intas Biopharma Plant, Ahmedabad, Gujarat

Salary will be offered as per industry standards and will be commensurate with experience, regulatory exposure, and role responsibility. Intas follows competitive compensation structures for biopharmaceutical regulatory professionals.

Application Process

Interested and eligible candidates are encouraged to apply through the official Intas application process by scanning the QR code provided in the recruitment notification.

Candidates should ensure that their profile highlights relevant regulatory submission experience and market exposure.

Why Join Intas Biopharma

• Leadership position in biosimilars and biopharmaceuticals
• Direct exposure to global regulatory submissions
• Strong regulatory systems and compliance culture
• Career growth in high-value regulatory affairs roles
• Opportunity to contribute to affordable global healthcare solutions

FAQs

Q1: Is biosimilar experience mandatory for this role?
Biosimilar regulatory experience is preferred but not mandatory.

Q2: Which markets will this role support?
The role supports submissions for US, EU, and other regulated and emerging markets.

Q3: What qualifications are accepted for this position?
M.Pharm, M.Sc Biotechnology, and M.Tech Biotechnology are accepted.

Q4: What is the experience range for this role?
Candidates with 2 to 10 years of regulatory affairs experience are eligible.

Q5: Where is the job location?
The position is based at the Intas Biopharma Plant in Ahmedabad.

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Job Summary Table

Company                                       Intas Pharmaceuticals Ltd.

Vacancies                                        Regulatory Affairs Executive / Senior Executive

Required Education                        M.Pharm, M.Sc (Biotech), M.Tech (Biotech)

Experience                                      2 –10 Years