AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
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Job Description
The Regulatory Affairs (RA) Associate is responsible for supporting or leading the preparation, filing, negotiation and approval of various types of regulatory submissions to Health Canada in support of AbbVie’s drugs and medical devices. These responsibilities are carried out in collaboration with key global and affiliate AbbVie stakeholders (e.g., regulatory, commercial, market access, medical, pharmacovigilance, and research & development teams).
In addition, the RA Associate is also expected to manage other regulatory-related activities, including but not limited to label reviews, and administrative responsibilities related to regulatory filings (i.e., data entry into the electronic data management system). The RA Associate may also be responsible for tasks in relation to regulatory operations.
Key Responsibilities:
- Prepare and/or support the filing, approval, and post-approval activities of various types of regulatory submissions including, but not limited to, clinical trial application activities, new and supplemental drug submissions, notifiable changes, and medical device-related submissions.
- 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 and provide Canadian regulatory guidance for assigned projects, as applicable. Work with Global Labelling Management to develop, update and approve label artwork.
- Ensure the timely data entry of all submission documents into the Affiliate and global electronic data management systems. Support or manage regulatory activities such as special access program requests and access to information requests. Support the review and impact assessment of global Standard Operating Procedures (SOPs) and update local Regulatory Affairs SOPs, as applicable. 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.
- Review and submit mandatory problem reports in compliance with the Canadian Medical Device Regulations as necessary.
Qualifications
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:
- 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.
Additional Information
AbbVie strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the following requirement, advanced amount of knowledge of English / Fluency in English is an essential requirement for the position, including, but not limited to, for the following reasons:
- English speaking employees outside the province of Quebec.
- English speaking clients outside the province of Quebec.
- Anglophone region outside the province of Quebe
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
