Alembic Pharmaceuticals, a Great Place to Work Certified company touching lives for over 100 years, is seeking experienced professionals for Regulatory Affairs roles at our Corporate Office in Vadodara. If you’re a B.Pharm or M.Pharm graduate with 7-15 years of dossier filing experience in Mexico or ASEAN countries, join us to drive regulatory excellence!
Job Overview
We’re recruiting for Senior Executive, Assistant Manager, or Deputy Manager positions in Regulatory Affairs. This full-time, permanent role is based at our Vadodara headquarters and offers a chance to work with a globally respected pharmaceutical leader.
- Industry: Pharmaceuticals
- Employment Type: Full-Time, Permanent
- Designation: Sr. Executive / Asst. Manager / Dy. Manager – Regulatory Affairs
- Experience Level: 7-15 Years
- Location: Corporate Office, Vadodara, Gujarat, India
Job Responsibilities
As a Regulatory Affairs professional, you’ll ensure compliance and support product registrations with minimal supervision. Your key duties will include:
- Compiling and reviewing product license applications, variations, and renewals for Mexico or ASEAN countries per regulatory requirements.
- Managing electronic documents and creating submissions in eCTD format.
- Preparing and reviewing responses to regulatory authority queries during registration and product lifecycle.
- Tracking assigned projects and ensuring dossiers are delivered per timelines.
- Designing, reviewing, and approving artwork for registration purposes.
- Conducting dossier due diligence for in-licensed products from other companies.
- Supporting the preparation of meeting materials (e.g., regulatory project status, submission, and approval updates) on a monthly, quarterly, or yearly basis.
Job Criteria
We’re looking for candidates with the following qualifications and skills:
- Qualifications: B.Pharm or M.Pharm.
- Experience: 7-15 years with dossier filing experience in Mexico or ASEAN countries.
- Skills:
- Knowledge of reviewing quality documents (e.g., executed batch documents, method validation, change controls).
- Proficiency in regulatory submissions and eCTD formatting.
- Strong communication skills.
How to Apply
Ready to join our Regulatory Affairs team? Here’s how to submit your application:
| Field | Details |
|---|---|
| Application Method | Email CV to hrd@alembic.co.in with subject line “RA-2025” |
| Location | Alembic Pharmaceuticals, Corporate Office, Vadodara, Gujarat, India |
| Deadline | Apply Now – Open until filled |
Application Requirements
- Updated CV.
- Mention position code “RA-2025” in the email subject line.
- Optional: Cover letter highlighting relevant experience.
Why Join Alembic Pharmaceuticals?
Alembic Pharmaceuticals has been a trusted name in healthcare for over a century, certified as a Great Place to Work. By joining our Vadodara team, you’ll:
- Work with a company renowned for quality and innovation.
- Contribute to regulatory strategies for international markets.
- Grow your career in a supportive and dynamic environment.
About Alembic Pharmaceuticals
Headquartered in Vadodara, Alembic Pharmaceuticals is a leading global player in pharmaceuticals, delivering high-quality products across diverse therapeutic areas. Visit www.alembicpharmaceuticals.com to learn more about our legacy and vision.
Ready to Apply?
Don’t miss this opportunity to advance your career with Alembic Pharmaceuticals! Email your CV to hrd@alembic.co.in with the subject line “RA-2025” today. We look forward to welcoming experienced Regulatory Affairs professionals to our Vadodara team!
