Associate, Regulatory Affairs

3 days ago

Brampton, Ontario, Canada SUN PHARMA Full time $60,000 - $90,000 per year

Job Purpose
Prepare and file drug product submissions to the US FDA, Health Canada as well as to assist with global drug product registrations.

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, MHRA, 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.
  • Strong working knowledge of current regulatory guidelines for FDA and / or TPD.
  • Experience with eCTD submissions and knowledge of GMP and QA/QC procedures is preferred.
  • Knowledge of the use of eCTD Software for preparing and filing submissions preferred.
  • Strong organizational ability to maintain a complex and high volume of technical information up to date.
  • Proficiency with applicable computer software – Microsoft Office including Word, Excel and PowerPoint and Adobe Acrobat and Document Management Systems.
  • Excellent interpersonal, written and verbal communication skills.
  • Ability to plan, coordinate and work effectively in a team-oriented 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 role

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