Corona Remedies Pvt. Ltd., one of India’s fastest-growing pharmaceutical companies with a turnover of ₹1200+ crore and an 18% CAGR, is expanding its global footprint and seeking a talented Assistant Manager, Regulatory Affairs for the Canada and Australia markets. Headquartered in Ahmedabad, Gujarat, Corona Remedies operates 11 divisions, employs 4500+ professionals, and holds a leadership position in women’s healthcare.
With 7 brands acquired from MNCs and a presence in 40+ countries, we invite experienced regulatory professionals to join our family at our Thaltej head office and contribute to our mission of delivering world-class healthcare solutions.
Why Work at Corona Remedies?
Rated 4.0/5 on AmbitionBox for work culture and 3.9/5 for job security, Corona Remedies fosters a dynamic and innovative environment. Our regulatory affairs team plays a pivotal role in ensuring compliance with stringent international standards, supporting our growth in highly regulated markets like Canada and Australia.
- Work with a rapidly growing organization exporting to 40+ countries, with a focus on North America and Oceania
- Contribute to a portfolio of 1500+ products, including leadership in women’s healthcare and chronic therapies
- Benefit from a collaborative culture with opportunities for professional development
- Engage in end-to-end regulatory processes in a USFDA, TGA, and Health Canada-compliant framework
Open Position
Assistant Manager, Regulatory Affairs (Canada & Australia Markets)
- Location: Corona Remedies Pvt. Ltd., Head Office, A-1201, Siddhi Vinayak Towers, Thaltej, Ahmedabad, Gujarat 380054
- Qualification: B.Pharm / M.Pharm from a recognized institution
- Experience: 5–8 years in Regulatory Affairs, specifically for Canada and Australia markets
Skills Required:
- Complete knowledge of dossier preparation and submission processes for Canada (Health Canada) and Australia (TGA)
- Proven ability to independently compile and submit dossiers, including eCTD format
- Strong understanding of regulatory pathways (e.g., NDS, ANDS, CTD for Canada; Category 1, 2 for Australia)
- Expertise in labeling requirements specific to Canadian (e.g., PM, PLA) and Australian (e.g., ARTG, PI/CMI) markets
- Proficiency in managing regulatory databases and product lifecycle documentation
- Excellent communication skills for cross-departmental coordination and client interactions
- Familiarity with cGMP, ICH guidelines, and QMS processes
Responsibilities:
- Manage end-to-end dossier filing for Canada and Australia, from literature search to submission
- Conduct literature searches to support drug product development phases
- Coordinate daily with plant departments (e.g., R&D, QC, production) and clients to ensure timely dossier submissions
- Compile and submit regulatory dossiers in compliance with Health Canada and TGA requirements
- Maintain and update regulatory databases, ensuring accurate product lifecycle management
- Review commercial documents (e.g., artworks, packaging) for compliance with Canadian and Australian labeling standards
- Stay updated on regulatory changes and guidelines in Canada and Australia
How to Apply
Interested candidates should send their updated CV to yashb@coronaremedies.com, with the subject line “Assistant Manager Regulatory Affairs – Canada/Australia Markets.” Alternatively, apply by scanning the QR code provided in the original job posting. Ensure your CV highlights your experience in Canada and Australia regulatory submissions, dossier preparation, and labeling compliance.
For inquiries, contact the HR team at +91-79-6777-9999 or visit www.coronaremedies.com. Note: Candidates who have interviewed with Corona Remedies in the last six months are not eligible to apply.
Application Deadline: Open until filled, but applications are encouraged by April 30, 2025, for priority consideration.
Join Corona Remedies’ Mission!
Be part of a dynamic pharmaceutical leader driving innovation and quality across global markets. As an Assistant Manager, Regulatory Affairs at Corona Remedies, you’ll play a critical role in expanding our presence in Canada and Australia, ensuring compliance and excellence in healthcare delivery. We look forward to welcoming you to our Ahmedabad team!
Note: Corona Remedies Pvt. Ltd. does not charge any fees for job applications, processing, or interviews. Beware of fraudulent communications requesting payments. Verify all job-related correspondence through the official website or email (yashb@coronaremedies.com).
