Job Description

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 companys growth and advancements in global healthcare, Job Title: Senior Executive Regulatory Affaris Job Requisitions No : 13246 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 Strong communication skills Experience of handling RA tools Roles and Responsibilites Summary Of Job Functions Responsible for preparation of regulatory submissions (regulated and semi regulated markets) Key Responsibilities Responsible for authoring IMPD and MAA by collating all the documents for registration of biosimilar products in regulated market EU/US/ROW regions Preparation of scientific advice and briefing book documents for biosimilars Preparation of responses to queries received from various regulatory agencies To work within regulatory teams for effective preparation of CMC documents for regulated and semi regulated markets, Updating and maintaining the regulatory trackers with the required details Provide necessary regulatory assessment for change controls Qualification Required Pharm/B 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: 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