Strides Pharma Hiring Regulatory Affairs Professional in Bangalore

Strides Pharma Hiring for Regulatory Affairs – Emerging Markets | Bangalore

Strides Pharma Science Limited, a leading pharmaceutical company, is looking for experienced professionals to join their Regulatory Affairs team in Bangalore. This exciting opportunity is aimed at candidates with 2-10 years of experience in handling regulatory activities for emerging markets including South Africa, Latam, SEA, GCC, CIS, and African countries.

This role is critical to ensuring compliance with regulatory standards and maintaining the company’s commitment to quality and excellence in emerging pharmaceutical markets.

Key Responsibilities

• Compile and Review Dossiers: Prepare, review, and compile registration and renewal dossiers as per the regulatory requirements of emerging markets (South Africa, Latam, SEA, GCC, CIS, and African countries).
• Document Review: Ensure thorough review of master documents including Product Development Plan (PDP), Product Development Report (PDR), Analytical Method Validation (AMV), Master Formula Records (MFR), Master Packing Records (MPR), Specifications, Process Validation Report (PVR), and Stability Protocols.
• Post-Approval Changes: Manage post-approval changes, ensuring seamless regulatory submissions and approvals for emerging markets.

Preferred Candidate Profile

• Experience: 2-10 years of relevant experience in regulatory affairs handling dossiers and post-approval changes.
• Technical Expertise: Strong knowledge in the review and compilation of various regulatory documents, particularly for emerging markets.
• Regulatory Knowledge: Familiarity with the regulatory landscape of South Africa, Latam, Southeast Asia (SEA), GCC, CIS, and African countries.

This role offers an excellent opportunity to work in a fast-paced and dynamic environment, contributing to the company’s growth in emerging global markets.

Location

This position is based in Bangalore, India.

How to Apply

If you meet the qualifications and are interested in exploring this opportunity, please share your profile with Navya at:

• Email: Navya@arcolab.com