Senior Associate, Regulatory Affairs
|Brampton Central, Ontario - Canada
contact recruiter for details
WHY IS THIS A GREAT OPPORTUNITY?
What is in it for you?
Opportunity to grow and develop
Strong Benefits Plan
Bonus based on performance
The goal of the Senior Regulatory Affairs Associate is to plan, coordinate, compile, submit, obtain approval, and maintain drug product registrations for the US and Canada, as well as assist global drug product registrations.
Principal Duties and Responsibilities :
- Plan, coordinate, compile and file drug product submissions for Canada and the U.S. 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 product 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.
- Plan, coordinate, compile and file post approval submissions for FDA (CBE supplement, PAS) and TPD (Notifiable Change, Supplement).
- Review Change Controls and determine filling requirements.
- Liaise with Health Canada and Provincial Formularies on all aspects of the drug submission, follow up for review status and project updates.
- Review submissions prepared by associates and senior associates.
- Work on more complex projects which involve identifying and resolving issues in a timely manner.
- Review and approve various product labeling components and marketing materials.
- In consultation with the manager, provide regulatory guidance and expertise to Sales & Marketing, R&D, QC/QA, and Operations departments
- Assist in preparation and compilation of FDA and TPD pre-approval and GMP inspections.
- 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.
University - Bachelor's Degree/3-4 Year Degree