AbbVie
Senior Manager, Regulatory Affairs
Montreal, QC, Canada · Senior
Sponsorship not specifiedDetected 8 hours ago
Project ManagementNegotiationSAPPharmacologyFDA RegulatoryPharmacovigilanceMedical DevicesResearchLeadershipCollaborationMentoringRegulatory Affairs
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odds of building a lasting career here
38Risky
Cap-exempt (no lottery)0
Sponsors this role85
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card follow-through: 59%
Of 22 labor certifications old enough to have been used, 9 expired without the employer filing the next step. Median time from filing to decision: 480 days.97% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
DOL often reclassifies their job titles
The Department of Labor assigned a different occupation than this employer requested on 44% of its 55 wage determinations — against a 18% norm. The occupation sets the prevailing wage floor.Reclassification is routine and can reflect genuinely hybrid roles; it is not by itself evidence of underpayment.
Files H-1B transfers
7 transfer filings in the last year, covering 7 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
Community outcomes
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About the role
- Our Great Place to Work® Certification highlights our dedication to cultivating a high-trust, and inclusive culture for all.
- At AbbVie, you won't just have a job, you'll have the opportunity to unlock a bright future, because we're not just a workplace; we're a world of possibilities.
- 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.
Responsibilities
- Supervise, manage, support and mentor direct reports.
- Actively support and participate in brand team meetings, as applicable.
- Actively support and assist in early pipeline touch point meetings, as applicable.
- Work with the AbbVie Global' Strategic Labelling team, the AbbVie Global Regulatory Affairs team, the Global Labelling Management team, and the affiliate brand teams to develop competitively differentiated Canadian labels and label artwork.
- 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.
- Support or manage regulatory activities related to special access program (SAP) requests, access to information requests and establishment licencing activities
Requirements
- 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
- Developed expertise in the field of Regulatory Affairs, and a good understanding of the Business environment, products, and service areas
- Experience with electronic regulatory submissions.
- Team player with experience in managing, coaching and mentoring employees
Nice to have
- Preferred 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.
Benefits
- 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.
Company info
- We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
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.html
This listing is sourced directly from AbbVie's careers page and normalized into a canonical job model.