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Corona Remedies Limited, a rapidly growing pharmaceutical leader with a 1200+ Cr. turnover and 18% CAGR, is hiring an Assistant Manager for Regulatory Affairs focused on the Europe market. Join our innovative team in Ahmedabad and contribute to our leadership in women’s healthcare and global expansion!
Event Details
Application Deadline: Ongoing (apply as soon as possible)
Work Location: Corona Remedies Head Office, Thaltej, Ahmedabad, Gujarat
Apply: Email CV to yashb@coronaremedies.com or scan the QR code on the job posting
Website: www.coronaremedies.com
Be part of one of India’s fastest-growing pharmaceutical companies with 4500+ employees and 11 divisions.
Open Position
Department: Regulatory Affairs
Position: Assistant Manager – Regulatory Affairs (Europe Market)
No. of Positions: 1
Job Location: Ahmedabad, Gujarat
| Position | Qualification | Experience | Key Responsibilities |
|---|---|---|---|
| Assistant Manager – Regulatory Affairs | B.Pharm., M.Pharm. | 7-10 Years (Europe RA) | Lead dossier preparation, EU eCTD submission, team management |
Role Highlights
- Dossier Management: Independently prepare and submit EU eCTD dossiers from start to finish, ensuring compliance with European regulatory requirements.
- Team Leadership: Manage a team of regulatory affairs professionals, coordinating workflows and ensuring timely submissions.
- Regulatory Strategy: Understand and navigate all EU regulatory pathways, including centralized, decentralized, and mutual recognition procedures.
- Cross-Functional Coordination: Communicate daily with plant departments and clients to align on dossier submission timelines.
- Literature Search: Conduct research to support the development phase of drug products.
- Database & Lifecycle Management: Oversee regulatory databases, manage product lifecycles, and review commercial documents.
- Labeling Compliance: Ensure adherence to labeling requirements specific to European countries.
Candidate Requirements
- Qualifications: B.Pharm. or M.Pharm.
- Experience: 7-10 years in Regulatory Affairs with specific expertise in the European market.
- Skills:
- Proven ability to independently compile and submit EU eCTD dossiers.
- Strong knowledge of EU regulatory pathways and labeling requirements.
- Excellent communication skills for internal and client interactions.
- Experience in team management and regulatory database oversight.
- Preferences: Prior experience in USFDA/EDQM-regulated environments, familiarity with women’s healthcare products, and proficiency in QMS documentation.
Why Join Corona Remedies?
Founded in 2004, Corona Remedies is headquartered in Ahmedabad and is recognized for its 4.0/5 work-life balance rating on AmbitionBox. With a leadership position in women’s healthcare, 7 acquired MNC brands, and approvals from USFDA, EDQM, and ANVISA, we offer a dynamic environment for career growth. Our Thaltej office fosters innovation and collaboration across 11 divisions. Learn more at Corona Remedies’ website.
How to Apply
Send your updated CV to yashb@coronaremedies.com, mentioning “Assistant Manager – Regulatory Affairs (Europe Market)” in the subject line. Alternatively, scan the QR code provided in the job posting to apply directly. Include your resume, educational certificates, and relevant experience details. For inquiries, connect via LinkedIn or visit www.coronaremedies.com.
