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About Intas

Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations. The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world.

Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare. The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world.

Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA. Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare.

At Intas, our success is fundamentally built on the strength of our people. Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence. This approach ensures that every employee plays a meaningful role in driving both the company’s growth and advancements in global healthcare.

Job Title:  Senior Executive - Regulatory Affaris

Job Requisitions No.:  13246
Job Description: 

Purpose of Job

To take responsibility for managing and processing dossier requests received from internal business partners. This role involves ensuring the timely preparation, review, and submission of regulatory dossiers, coordinating with cross-functional teams, and ensuring compliance with regulatory requirements for both domestic and international markets

Skill Required

  • Biosimilars Registration Experience: Proven experience in handling registrations of biosimilars in both regulated and semi-regulated markets.

  • Dossier Drafting: Extensive experience in drafting and reviewing regulatory dossier sections for biosimilars and other biologics.

  • Query Response Drafting: Demonstrated experience in drafting clear and comprehensive responses to regulatory queries (e.g., DCGI, EMA, etc.).

  • Cross-Functional Coordination: Strong experience in coordinating and interacting with cross-functional teams (CFTs), including R&D, Clinical, Quality, and Manufacturing, to align on regulatory requirements and submission strategies.

  • Communication Skills: Excellent verbal and written communication skills, with the ability to effectively convey complex regulatory information to both internal teams and regulatory authorities.

  • Regulatory Affairs Tools: Experience in utilizing Regulatory Affairs (RA) tools for tracking submissions, managing queries, and ensuring the integrity of regulatory data.

Roles and Responsibilites

  1. Regulatory Submissions:

    • Author and prepare IMPD (Investigational Medicinal Product Dossier) and MAA (Marketing Authorization Application) by collating all necessary documents for the registration of biosimilars in regulated markets (EU/US/ROW regions).

  2. Scientific Advice and Briefing Documents:

    • Prepare scientific advice and briefing book documents for biosimilars, ensuring clear and accurate presentation of data to regulatory agencies.

  3. Query Responses:

    • Draft and prepare responses to queries received from various regulatory agencies, ensuring timely and accurate submission to facilitate smooth regulatory reviews.

  4. CMC Document Preparation:

    • Collaborate with the regulatory team to prepare CMC (Chemistry, Manufacturing, and Controls) documents for both regulated and semi-regulated markets, ensuring compliance with all regulatory guidelines and standards.

  5. Regulatory Tracking:

    • Update and maintain regulatory trackers with the latest information, ensuring accurate documentation of submission statuses, timelines, and regulatory outcomes.

  6. Change Control Assessment:

    • Provide necessary regulatory assessment for change controls, ensuring that changes are aligned with regulatory requirements and that all necessary documentation is in place.

Qualification Required

M.Pharm / B.Pharm from a reputed university
Experience in biological sciences is an added advantage/preferred.

Competencies

Intas - Action Oriented
Intas - Customer Focus
Intas - Dealing with Ambiguity
Intas - Problem Solving
Intas - Time Management

Relevant skills / Industry experience

3-5 years of experience in Regulatory affairs with biosimilars 
Location: 

Biotech, Ahmedabad, GJ, IN, 382213

Travel:  0%

Life at Intas Pharmaceuticals

For over three decades, Intas has thrived due to the exceptional talent of its people. Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success. We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape.
Date:  11 Apr 2025

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