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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

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