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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:  Asst. Manager - Regulatory Affairs

Job Requisitions No.:  13244
Job Description: 

Purpose of Job

The purpose of the job is to take the responsibility of Dossier requests received from internal business partners.

Skill Required

  • Experience of handling registrations of biosimilars in regulated and semi regulated markets.
  • Experience of drafting dossier sections
  • Experience of drafting query responses
  • Experience of interactions and co-ordination with CFTs, country agencies and business partners
  • Strong communication skills
  • Experience of handling RA tools

Roles and Responsibilites

Summary of Job Functions:

Providing regulatory support to enable major markets and ROW market submissions. Play a key role in leading the efforts for life-cycle management activity across Geographies.

Key Responsibilities:

  • Authoring, compilation and submission of MAAs for biosimilars in Regulated and Emerging Markets
  • Preparation and timely submission of query responses to HAs and business partners/affiliates
  • Preparation of documents for variation filing to support product life-cycle management in Regulated and Emerging Markets
  • Review and share inputs on source documents required for authoring of MAAs, variation applications and other regulatory submissions
  • Closely work with CFTs/SMEs to track and comply with regulatory commitments & preparation of documents required for RA Compliance
  • Archival of Regulatory documentation and timely update of regulatory trackers
  • Training new juniors

Qualification Required

M.Pharm/B.Pharm from reputed university

Biological experience is added advantage/preferable

Competencies

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

Relevant skills / Industry experience

Relevant professional / Educational background

Any other requirements (If any)

Compensation / Reward
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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