Regulatory Affairs - Senior Assocciate
|Brampton West, Ontario - Canada
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WHY IS THIS A GREAT OPPORTUNITY?
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The Regulatory Affairs Associate is responsible for compiling, submitting, and maintaining drug product registrations for the US and Canada, as well as to assist with global drug product registrations.
Principal 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.
Knowledge, Skills and Abilities
- 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.
University - Bachelor's Degree/3-4 Year Degree