Regulatory Affairs Pro Wanted! Join Intas Pharmaceuticals as Assistant Manager

Job Opening: Regulatory Affairs – Assistant Manager

Intas Pharmaceuticals, a renowned name in the pharmaceutical industry with a thriving Biopharma Division, is on the lookout for a talented individual to join our Regulatory Affairs team as an Assistant Manager. If you are passionate about regulatory compliance and want to contribute to the success of biosimilar products, this is the opportunity for you.

About the Company (Intas Pharmaceuticals): Established as a humble beginning, Intas Pharmaceuticals has grown into a global player in the pharmaceutical industry. Our commitment to innovation, quality, and customer satisfaction has propelled us to the forefront of the market. Founded by visionary leaders, our company culture encourages continuous learning and excellence.

Company Vacancies List:

• Position Title: Assistant Manager – Regulatory Affairs
• Company Name: Intas Pharmaceuticals
• Salary: Competitive, commensurate with experience

Job Description:

About the Department & Responsibilities: The Regulatory Affairs team at Intas Pharmaceuticals plays a pivotal role in ensuring compliance and facilitating the approval processes for our biosimilar products. As an Assistant Manager, you will be responsible for:

• Preparing regulatory submissions for biosimilar products in regulated, semi-regulated, and domestic markets.
• Authoring CMC dossiers for clinical trial approvals and marketing authorization for biosimilars and gene therapy products in India.
• Submitting applications for approval of animal toxicity studies and handling IBSC activities.
• Preparing scientific advice and briefing book documents for biosimilars.
• Responding to queries from various regulatory agencies.
• Filing applications for seeking manufacturing NOC and import licenses from CDSCO (zonal) and DCGI.
• Collaborating with regulatory teams to prepare CMC documents for domestic, semi-regulated, and regulated markets.

How to Apply: If you possess the required qualifications and are eager to contribute to regulatory excellence, we invite you to send your profile to solaya_sinha@intaspharma.com.