- Prepare and/or support the filing, approval, and post-approval activities of various types of regulatory submissions including, but not limited to, clinical trial applications (CTA) and CTA amendments, new and supplemental drug submissions, and notifiable changes.
- Under the supervision of the RA Manager (or RA Project Lead) review and assist in the evaluation of supportive filing documentation for conformance with Health Canada’s Food and Drugs Act and Regulations, policies and guidelines.
- Support the preparation of pre-submission meetings with Health Canada. This includes, but is not limited to, the preparation of pre-meeting materials and presentations.
- Liaise with the Global regulatory team to follow up and provide Canadian regulatory guidance for assigned projects, as applicable.
- Ensure the timely data entry of all submission documents into the Affiliate and global electronic data management systems.
- Support or manage regulatory operation tasks such as special access program requests, access to information requests and drug establishment licences activities.
- Read, understand, and comply with assigned trainings and complete within pre-established deadlines.
- Keep abreast of revisions to the Canadian Food and Drugs Act and Regulations, related policies and guidelines as these pertain to RA activities.
- Keep immediate supervisor informed on all RA-related activities.
- Operate in compliance with local regulations and company policies and procedures.
Education/ Experience required:
- Bachelor’s degree in Pharmacy, Biology, Pharmacology or related Life Sciences is required.
- Master of Science degree or Doctorate in Biochemistry, Biology, Microbiology, Chemistry, Toxicology, Pharmacology or in Management, such as a Master of Business Administration degree, is considered an asset.
- Minimum of one to three years of experience in the pharmaceutical industry.
- Working knowledge in the preparation, filing, and approval of various submission types with Health Canada, and basic negotiation and networking skills.
- Experience with Biologics, small molecules, medical devices, quality-related changes, and clinical trial applications are considered an asset.
- Basic knowledge and understanding of the Canadian Food and Drugs Act and Regulations, its policies, and related guidelines.
- Computer proficient.
- Experience with electronic regulatory submissions is considered an asset.
Essential skills and abilities:
- Oral/written communication skills. Fluent English, good French (oral & written).
- Able to effectively and efficiently work either on his/her own or in a team environment.
- Able to take key actions and demonstrate behavioural anchors that support all AbbVie core competencies.
AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.
Covid vaccination new hires amendments:
Full vaccination against COVID-19 is a condition of employment for this position, with possible accommodation for validated exemptions, within the limits of applicable legislation. AbbVie employees are also required to comply with any COVID-19 related external requirements, including any testing requirements, applicable to their work activities outside AbbVie premises (for example, travelling and visiting stakeholders and customers).
Job Type: Temporary Work