Location: Bangalore, India
Company: Strides Pharma Science Limited
Experience Required: 2–10 Years
Job Description
Strides Pharma Science Limited is seeking an experienced Regulatory Affairs Professional to manage dossier submissions and compliance for Emerging Markets, including South Africa, LATAM, SEA, GCC, CIS, and African Countries.
Key Responsibilities:
- Review and compile registration & renewal dossiers as per Emerging Market regulations.
- Evaluate master documents (PDP, PDR, AMV, MFR, MPR, Specifications, PVR, Stability Protocols) and DMF.
- Handle post-approval changes for regulatory compliance in target markets.
- Ensure adherence to regional regulatory guidelines and timely submissions.
About the Hiring Company: Strides Pharma Science Limited
Strides Pharma is a globally recognized pharmaceutical company specializing in generic and specialty medicines. With a strong presence in 100+ countries, Strides is known for its high-quality, affordable healthcare solutions and compliance with international regulatory standards.
Eligibility Criteria
Preferred Qualifications & Experience:
- 2–10 years of experience in Regulatory Affairs (Emerging Markets).
- Strong knowledge of dossier compilation, renewals, and post-approval changes.
- Familiarity with regulatory guidelines in South Africa, LATAM, GCC, CIS, and Africa.
- Attention to detail and ability to work in a fast-paced regulatory environment.
How to Apply
Interested candidates meeting the eligibility criteria can share their updated resume/CV to:
Email: Navya@arcolab.com
Please mention “Application for Regulatory Affairs – Emerging Markets” in the subject line for faster processing.
