At a Glance
- Tasks: Lead a team in navigating regulatory submissions and approvals for innovative health solutions.
- Company: Join AbbVie, a leader in healthcare innovation with a commitment to making a difference.
- Benefits: Enjoy competitive pay, inclusive culture, and opportunities for professional growth.
- Other info: Be part of a diverse team dedicated to transforming lives and driving innovation.
- Why this job: Make a real impact on health by guiding groundbreaking products through regulatory processes.
- Qualifications: 10+ years in pharma, leadership experience, and strong regulatory knowledge required.
The predicted salary is between 82800 - 101200 $ per year.
About AbbVie: 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 including immunology, oncology, neuroscience, eye care, virology, women’s health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
The Senior Manager, Regulatory Affairs (SrMRA) is responsible for the direction, management and oversight of a team of Regulatory Affairs professionals and their respective activities. The SrMRA also provides strategic input and actively supports the filing and approval with Health Canada of various types of regulatory submissions in support of AbbVie’s development and marketed products portfolio, including medical devices.
Key responsibilities include:
- Strategically support and/or prepare the filing, approval, and post-approval activities of several types of regulatory submissions including clinical trial application activities, new drug submissions, supplemental new drug submissions, notifiable changes, and medical device-related submissions.
- Hold self and all direct reports accountable for regulatory-related projects and ensure regulatory submission filing and approval timelines are met.
- Supervise, manage, support and mentor direct reports.
- Conduct mid- and year-end performance evaluations with each direct report and provide timely constructive feedback on a regular basis.
- Review and assist in the evaluation of regulatory submission documents 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.
- Consult with the AbbVie Global Regulatory team to define filing strategies and provide Canadian regulatory guidance for assigned projects.
- Actively support and participate in brand team meetings, as applicable.
- Manage RA activities related to product in-licensing, divestitures and/or acquisitions.
- Oversee and ensure the timely data entry of all submission documents into the Canadian Affiliate and AbbVie Global’s electronic data management systems.
- Advise management of all regulatory-related activities, especially those that may impact the outcome of filings and/or approvals.
Education / Experience required:
- Bachelor’s degree in Pharmacy, Biology, Pharmacology, or related Life Sciences is required.
- Minimum of ten years of experience in the pharmaceutical industry.
- Minimum of four years of experience in leading a team of professionals.
- Proven success in the preparation, filing, and approval of various submission types with Health Canada.
- Developed expertise in the field of Regulatory Affairs.
- Experience with Biologics, small molecules, medical devices, quality-related changes, and clinical trial applications are an asset.
Essential Skills and Abilities:
- Team player with experience in managing, coaching and mentoring employees.
- Ability to take key action and demonstrate behavioural anchors that support all AbbVie core and leadership competencies.
AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.
Senior Manager, Regulatory Affairs in Québec employer: AbbVie
AbbVie is an exceptional employer that fosters a high-trust and inclusive culture, as evidenced by our Great Place to Work® Certification. Located in Quebec, we offer a vibrant work environment where employees can thrive through mentorship and professional development opportunities, all while contributing to innovative healthcare solutions that make a meaningful impact on people's lives. Join us to unlock a world of possibilities and be part of a team dedicated to transforming lives and addressing critical health challenges.
