Strides Pharma Hiring Regulatory Affairs
- Regulatory Affairs Openings for B.Pharm/M.Pharm | Strides Bangalore
- Company Overview
- Job Role & Responsibilities
- Core Responsibilities
- Eligibility / Qualifications
- Required Experience
- Location & Salary
- Application Process
- FAQs
- Summary Table
Regulatory Affairs Openings for B.Pharm/M.Pharm | Strides Bangalore
Strides Pharma hiring Regulatory Affairs professionals (2–12 yrs) for Emerging Markets at Bangalore. Apply now via email.
Strides Pharma Science Limited is hiring experienced Regulatory Affairs professionals for its Emerging Market division. This opportunity is suitable for candidates who have hands-on experience preparing regulatory dossiers, managing post-approval changes, and working with global quality and technical documentation. If you want to work in a high-compliance environment that supports global market submissions, this role offers solid growth and strong technical exposure.
Company Overview
Strides Pharma is a well-established global pharmaceutical manufacturer with a strong regulatory footprint across regulated and emerging markets. The company has a diverse portfolio spanning oral solids, semi-solids, sterile products, and value-driven specialty therapies. Its Regulatory Affairs team supports global submissions, lifecycle management, and compliance for multiple health authorities across South Africa, LATAM, Southeast Asia, GCC, CIS, and African countries.
Working with Strides means contributing to high-quality documentation, regulatory strategy, and global product approvals — all key components in ensuring safe and effective medicines reach international markets.
Job Role & Responsibilities
The role focuses on Emerging Market submissions and requires candidates who can work independently on document review, dossier compilation, and lifecycle management.
Core Responsibilities
- Review and compile registration and renewal dossiers as per country-specific guidelines for Emerging Markets.
- Review master documents including PDP, PDR, AMV, MFR, MPR, product specifications, PVR, and stability protocols.
- Coordinate and support preparation of DMFs and associated technical documentation.
- Handle post-approval variations, renewals, and change-control submissions for markets such as South Africa, LATAM, SEA, GCC, CIS, and Africa.
- Liaise with cross-functional teams including QA, QC, R&D, and Manufacturing to ensure dossier accuracy and completeness.
- Ensure compliance with regulatory requirements, documentation integrity, and country-specific filing expectations.
Eligibility / Qualifications
Preferred Education (comma-separated): B.Pharm, M.Pharm, MSc Regulatory Affairs, Pharmaceutical Chemistry, Drug Regulatory Affairs Certification, Quality & Compliance Certifications.
Required Experience
- 2–12 years of experience in Regulatory Affairs.
- Strong background in Emerging Market submissions.
- Experience reviewing master documents, stability protocols, and DMFs.
- Solid understanding of post-approval changes and lifecycle management.
- Ability to manage timelines, documentation quality, and cross-functional coordination.
Location & Salary
Location: Bangalore (Strides Pharma Science Limited)
Salary: Depends on experience and internal grade; competitive as per industry standards.
Application Process
Interested candidates should share their updated profile to:
Include:
- CV with detailed RA experience
- List of markets handled (e.g., South Africa, LATAM, GCC)
- Projects involving dossier compilation or post-approval variations
- Notice period and current CTC
The HR team will contact shortlisted candidates for further discussion.
FAQs
Q1. What markets will I be handling?
South Africa, LATAM, SEA, GCC, CIS, and African countries.
Q2. Is dossier compilation experience mandatory?
Yes. Hands-on dossier preparation and review is essential.
Q3. Can candidates from Manufacturing or QA transition to RA?
Possible only if they have prior RA exposure or strong documentation experience.
Q4. Is remote work available?
Roles are primarily office-based in Bangalore.
Q5. Are freshers eligible?
No. Minimum 2 years RA experience is required.
Summary Table
| Company | Strides Pharma Science Limited |
|---|---|
| Vacancies | Regulatory Affairs – Emerging Markets |
| Required Education | B.Pharm, M.Pharm, MSc Chemistry, Regulatory Affairs Certifications |
| Experience | 2–12 years in RA dossier preparation, DMF review, and post-approval changes |
To apply for this job email your details to Navya@arcolab.com
