Pharmacovigilance-Jobs in Deutschland

ICompany 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 at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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 AbbVie's 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 Canada's 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 Global's 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 Global's Strategic Labelling, AbbVie Global's Regulatory Affairs, and local brand teams to develop Canadian label.
• Work with AbbVie Global's 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 Global's 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 Global's 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

• 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 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 Québec

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 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.htmlI