Company: Parexel
Location: Remote (India) / Hyderabad
Experience: 3-8 years
Job Type: Full-time
Industry: Pharmaceuticals / Regulatory Affairs
Job Description
Parexel is seeking a Regulatory Affairs Associate & Sr. Regulatory Affairs Associate to join their consulting team. This role is crucial in helping biopharmaceutical and medical device companies navigate complex regulatory landscapes. The ideal candidate will work on lifecycle maintenance for approved products, including:
Key Responsibilities:
- Handling CMC variations (small molecules & biologics), administrative variations, renewals, and marketing authorization transfers.
- Managing manufacturing site transfers, site name changes, and safety/labeling updates for markets like Europe, ASEAN, and other regulated regions.
- Reviewing dossiers in eCTD format for EU and international submissions.
- Addressing Health Authority queries efficiently and accurately.
- Managing change control processes and ensuring compliance.
- Coordinating with internal & external stakeholders for timely regulatory submissions.
- Identifying process gaps and suggesting improvements for regulatory excellence.
Eligibility Criteria:
✔ 3-8 years of experience in regulatory submissions (EU experience preferred).
✔ Expertise in post-approval changes for EU markets.
✔ Familiarity with RIMS tools (Veeva Vault is a plus).
✔ Strong communication, problem-solving, and strategic thinking skills.
About Parexel
Parexel is a leading clinical research organization (CRO) supporting biopharmaceutical and medical device companies in drug development and regulatory compliance. With a global presence, Parexel offers consulting services to accelerate product approvals while maintaining regulatory standards.
Why Join Parexel?
✅ Remote work flexibility with a supportive team.
✅ Exposure to diverse therapeutic areas and regulatory challenges.
✅ Career growth through mentorship and continuous learning.
✅ Collaborative culture fostering innovation and excellence.
How to Apply
Interested candidates can apply directly through Parexel’s career portal.
