Apsida Life Science is partnering with a global CRO company to present the following role:

Regulatory Affairs Consultant – Biosimilars, MAA & MAH (India)

Location: India

Engagement Type: Independent Consultant (IC)

Project: Regulatory Feasibility & Market Entry

Role Overview

We are looking for an experienced Regulatory Affairs Consultant to support the assessment of biosimilar products that have already been approved in the EU and other major markets and are now being considered for entry into India.

The consultant will help determine the feasibility of obtaining Marketing Authorisation in India for each product, including the applicable clinical requirements and whether a Phase III clinical trial waiver may be possible.

The role will also involve exploring options for appointing a suitable Marketing Authorisation Holder (MAH) in India on a temporary basis ahead of commercial launch.

Key Responsibilities

- Assess the feasibility of obtaining Indian Marketing Authorisation for biosimilars already approved in the EU and other major markets.
- Review existing approvals and supporting data to identify any additional requirements for Indian submissions.
- Advise on the appropriate Marketing Authorisation Application (MAA) pathway for each product, including applicable CDSCO requirements and potential regulatory gaps.
- Evaluate local clinical requirements and the possibility of obtaining a Phase III clinical trial waiver.
- Identify any additional studies, documentation, or supporting evidence that may be required for submission.




- Explore options for appointing a suitable third party or service provider to act as the Marketing Authorisation Holder (MAH) in India before commercial launch.
- Advise on the eligibility, licensing requirements, and responsibilities associated with MAH arrangements, including the feasibility of a temporary setup.
- Provide practical recommendations on the most suitable regulatory pathway and next steps for each product.

Requirements

- Solid experience in Indian Pharmaceutical Regulatory Affairs, particularly biosimilars and biologics.
- Hands-on experience with Indian Marketing Authorisation Applications (MAAs), ideally for biosimilars already approved in the EU or other major markets.
- Good understanding of CDSCO requirements and Indian biosimilar registration guidelines.
- Experience assessing clinical data requirements and the potential for Phase III clinical trial waivers.
- Knowledge of Indian MAH requirements, including licensing, eligibility, and third-party MAH arrangements.
- Experience supporting international pharmaceutical companies with Indian market entry and regulatory strategy.
- Ability to provide clear, practical advice on regulatory feasibility and the best way forward.

If you are interested in learning more, please reach out to Mufaro Mpofu at Apsida Life Science:

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www.apsida.co.uk.

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process

📌 Regulatory Affairs Consultant (India)
🏢 Apsida Life Science
📍 India