Join Shilpa Biologicals’ Regulatory Team: MSc Biotech / B Tech Positions Open

Join Shilpa Biologicals, a leader in the biotech industry, in our pursuit of excellence in regulatory affairs. We are currently seeking dedicated professionals to join our Regulatory Team and contribute to our mission of delivering innovative biotech solutions.

About Shilpa Biologicals

Company Overview

Shilpa Biologicals is a renowned name in the biopharmaceutical industry, committed to developing and manufacturing high-quality biotech products. With a legacy of innovation and excellence, we strive to address unmet medical needs and improve the quality of life for patients worldwide.

Shilpa Biologicals Vacancies List

Regulatory Affairs Positions Available:

• Sr. Executive – Regulatory Affairs

Job Description

Sr. Executive – Regulatory Affairs

Qualification: Postgraduate in Life Science (MSc Biotech / BTech Biotech) Experience: 4 to 6 years

Responsibilities:

• Preparation and submission of Biologicals regulatory applications (NOC application, Import application, Clinical trial applications, marketing Authorization Applications, etc.) to Indian agency.
• Preparation and submission of CTD/country specific dossiers (CMC, clinical and non-clinical sections) for emerging markets.
• Knowledge/exposure to regulated markets (USA and Europe) submissions.
• Review R&D, QA, QC data required for dossier compilation.
• Experience in proofread (labelling) of regulatory documentation.
• Provide RA support to CFT for audits.
• Experience dealing with CDSCO offices and well versed with online portals like SUGAM.
• Manage electronic regulatory media and prepare electronic submissions.
• Assist in getting notarized/legalized documents from commerce chamber and embassy and regulatory samples handling.
• Passionate to take new challenges.

How to Apply

Interested candidates can share their profiles with:

• harikrishnau@shilpabio.com
• asasidharan@shilpabio.com