Senior Regulatory Affairs – Pharmaceutical

Full Time

What is in it for you?

3 weeks vacation
Upward mobility
Full Benefits

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 five (5) to seven (7) years of hands-on Regulatory Affairs experience of filing and managing Canadian and USA submissions, including electronic submissions in eCTD formats.
  • Expertise in chemistry and manufacturing, labeling and format requirements for drug product registration for FDA (ANDA, NDA, DMF, IND) and TPD (CTA, ANDS, S/ANDS, NDS, DIN, DMF).
  • Knowledge of the use of eCTD Software for preparing and filing submissions preferred.
  • Knowledge of GMP requirements and QA/QC procedures.
  • Excellent interpersonal, written and verbal communication skills.
  • Ability to plan, coordinate and work effectively in a team-oriented environment.
  • Superior computer software skills (Microsoft Word, Excel, Access, PowerPoint, Adobe Acrobat, Document Management Systems).
  • Strong organizational ability and management of multiple priorities combined with proven ability to meet strict and established timelines.
  • Multi-tasking various tasks and adhering to strict timelines.
  • Good problem solving abilities required to prepare written responses to deficiency letters from regulatory agencies, as well as obtain approval of changes to approved drug products.

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