Senior Regulatory Affairs Associate
Senior Regulatory Affairs Associate
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Job Description
The ideal candidate will work from our StLaurent QC offices.
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 AbbVies 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 regulatoryrelated 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 postapproval 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 devicerelated submissions.
Participate review and assist in the evaluation of supportive filing documentation for conformance with Health Canadas Food and Drugs Act and Regulations policies and guidelines.
Support the preparation and conduct of presubmission meetings with Health Canada. This includes but is not limited to the preparation of premeeting materials and meeting presentation.
Liaise with the Global regulatory team and provide Canadian regulatory guidance for assigned projects as applicable.
Work with AbbVie Globals Strategic Labelling AbbVie Globals 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 preestablished 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 RArelated activities.
Operate in compliance with local regulations and company policies and procedures.
Qualifications :
Education/ Experience Required:
Bachelors 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 qualityrelated 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.
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 Associate 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 visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
