Associate, Regulatory Affairs

Job purpose

Prepare and file drug product submissions to the US FDA, Health Canadaas 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