Associate, Regulatory Affairs (Contract)

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 wi...