Project Manager, Regulatory Affairs
Project Manager, Regulatory Affairs
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
The Regulatory Affairs Project Manager (RAPM) 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 internal stakeholders (e.g. local and AbbVie Global Regulatory Affairs Commercial Market Access Medical Affairs Pharmacovigilance and Research & Development teams). The RAPM supports brand teams on assigned projects by understanding all aspects of the business and by sharing regulatoryrelated decisions initiatives issues and updates with team members in a timely fashion. The RAPM is also responsible for communicating and ensuring that Regulatory Affairs Management is advised on key issues and updates discussed at brand team meetings.
In addition the RAPM also acts as a key resource for the support and guidance to more junior RA team members as required.
Key responsibilities
- Prepare and/or support the filing approval and post-approval activities of several 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.
- Hold self accountable for regulatory-related projects and ensure regulatory submission filing and approval timelines are met.
- Participate review and assist in the evaluation of supportive filing documentation for conformance with Health Canadas Food and Drugs Act; 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.
- Consult with the AbbVie Globals Regulatory team to define filing strategies and provide Canadian regulatory guidance for assigned projects.
- Support and participate in brand team meetings on assigned projects.
- Assist in early pipeline Touchpoint meetingsas applicable.
- Work with AbbVie Globals Strategic Labelling AbbVie Globals Regulatory Affairs and local brand teams to develop Canadian label.
- Work with AbbVie Globals Labelling Management team to develop update and approve label artwork.
- Actively participate in new product introduction (NPI) and launch readiness review (LRR) meetings and provide timely regulatory updates as applicable.
- Manage RA activities related to product in-licensing divestitures and/or acquisitions.
- Perform regulatory review of promotional material as applicable.
- Ensure the timely data entry of all submission documents into the Canadian Affiliate and AbbVie Globals electronic data management systems.
- Support or manage regulatory activities such as special access program (SAP) requests and access to information requests as necessary.
- Read understand and comply with assigned trainings and complete within pre-established deadlines.
- Keep abreast of revisions to the Canadian Food and Drugs Act; regulations related policies and guidelines that pertain to RA activities.
- Review coordinate the review and provide comments to new proposed / draft Health Canada guidances and policies and communicate to management accordingly.
- Support the review and impact assessment of AbbVie Globals standard operating procedures (SOPs) and update local Regulatory Affairs SOPs as applicable.
- Support and provide guidance to junior or new RA team members as required.
- Keep immediate supervisor / management informed on all RA-related activities especially those that may impact the outcome of filings and/or approvals.
- 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 five to eight years of experience in the pharmaceutical industry.
- Extensive knowledge in the preparation filing and approval of various submission types with Health Canada and negotiation and networking skills.
- Experience with Biologics small molecules medical devices quality-related changes and clinical trial applications are considered an asset.
- Developed 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 (verbal and written); good French (verbal and written) as applicable*.
- 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.
*applicable to employees in Qubec
Additional Information :
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 :
Full-time
Employment Type
Full-time
