Senior Associate, Regulatory Affairs

AbbVie Inc; Markham; On-site; CAD 80,000 - 120,000; Full time

Job summary

A leading global biopharmaceutical company is seeking a Senior Regulatory Affairs Associate to join their team in Markham. In this role, you will be responsible for regulatory submissions and collaboration with key stakeholders to support AbbVie's innovative medicines. The ideal candidate will have a strong background in regulatory affairs within the pharmaceutical industry and demonstrate effective communication, negotiation, and networking skills.

Qualifications

• Minimum 3-5 years of experience in the pharmaceutical industry.
• Strong working knowledge in regulatory submissions with Health Canada.
• English fluency essential; good French is a plus.

Responsibilities

• Prepare and support regulatory submissions to Health Canada.
• Liaise with global teams for regulatory guidance.
• Ensure compliance with Canadian Food and Drugs Act.

Skills

Negotiation

Networking

Communication Skills

Education

Bachelor's degree in Pharmacy, Biology, Pharmacology or related Life Sciences

Master of Science degree or Doctorate in relevant fields

Tools

Electronic data management systems

Job description

Company Description

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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

When choosing your career path, choose to be remarkable.

Job Description

The ideal candidate willwork from our Markham, ON office.

The Senior Regulatory Affairs 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 Senior 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 Senior 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.
• Participate, 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 and conduct of pre-submission meetings with Health Canada. This includes, but is not limited to, the preparation of pre-meeting materials and meeting presentation.
• Liaise with the Global regulatory team and provide Canadian regulatory guidance for assigned projects, as applicable.
• Work with AbbVie Global’s Strategic Labelling, AbbVie Global’s Regulatory Affairs, and local brand teams to develop Canadian label.
• 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 coordination of comments to new “proposed / draft” Health Canada guidances and policies and communicate to management accordingly.
• 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.

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 three to five years of experience in the pharmaceutical industry.
• Strong 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.
• Proficient 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.
• Oral/written communication skills. Fluent English (verbal and written); good French (verbal and written).

• 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 of Senior Regulatory Affairs Associatet 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 Quebec.

Additional Information

AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.

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, visithttps://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