Title: Associate, Regulatory Affairs (Contract)
Date:
Mar 24, 2025
Location:
Sun Pharma Canada Inc.
Company:
Sun Pharma Canada Inc.
Job purpose
Prepare and file drug product submissions to the US FDA and Health Canada.
Duties and responsibilities
- Prepare and / or review submissions to Health Canada and FDA for a variety of dosage forms (solid oral, liquids, topical semisolids and injectables) in eCTD format (e.g. DMFs, ANDS, NDS, ANDA, NDAs, S/NDSs, DINs, CTAs, NCs, INDs, provincial formulary submissions etc.) for the successful registration of drug products for domestic and international markets.
- Prepare submissions in eCTD format which involves full understanding of the use of Adobe Acrobat to create bookmarks and links.
- Prepare written responses to deficiency letters from regulatory agencies in the stated time frame.
- Prepare and file post approval submissions for FDA (CBE supplement, PAS) and TPD (Notifiable Change, Supplement).
- Maintain approved product monographs to comply with CRP-PMs.
- Maintain approved drug products for FDA (Annual Report) and TPD (Annual Drug Notification).
- Review and approve various product labeling components and marketing materials.
- Review internal documentation (master batch records, specifications, labeling, product monographs) for adherence to regulatory guidelines.
- Assist in global drug product registrations.
- Maintain current awareness of regulatory guidelines (Health Canada, FDA, ICH, European Medicines Agency - EMeA, Therapeutic Goods Administration –TGA Australia, etc.).
- Other duties as required by the Manager.
Additional responsibility (Only applicable to customer facing roles)
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day
Qualifications
- Minimum B. Sc. in a Chemistry, Pharmacy or Life Science discipline combined with at least three (3) to five (5) years of relevant experience within a Canadian and / or USA Regulatory Affairs pharmaceutical environment.
Working conditions
- Multidisciplinary office, R&D and manufacturing environment
- Extensive use of computer
- Varied work schedule to meet deadlines, as required
Physical requirements
Office based / Hybrid role
Direct reports
NA