Regulatory Affairs Associate — Canada

Regulatory Affairs Associate — Canada

The Regulatory Affairs Associate is responsible for planning, coordinating, compiling, submitting, obtaining approval, maintaining drug product registrations for Canada and the U.S. and assisting global drug product registrations.

Type:

12-month Contract with an opportunity to convert to full-time based on performance.

Location:

Not specified.

Key Responsibilities:

• Plan, coordinate, compile and file drug product submissions for Canada and the U.S. for a variety of dosage forms in eCTD format (e.g. DINs, ANDS, NDS, ANDA, NDAs, S/NDSs, CTAs, NCs, provincial formulary submissions etc.) for the successful registration of drug product for domestic and international markets, with limited supervision.
• Review and approve various product labelling components and marketing materials.
• Prepare submissions in eCTD format, which...