Project Leader, Regulatory Affairs

Apotex
Posted

Post Expires

Type

Mid-level industry position

Project Leader, Regulatory Affairs

Company: Apotex

 

Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

 

Job Summary

• Supports the RA Canada & Caribbean team in scheduling, prioritizing and compiling regulatory submissions of Apotex products to the Canadian federal & provincial regulatory authorities for approvals, and supports RA labeling team with post-approval regulatory labeling activities.  • Acts as the lead for regulatory activities pertaining to in- and out-licensed products, and AA Pharma products.  • Supports and serves as the primary contact for regulatory activities pertaining to third parties.  • Liaises regularly with Sales and Marketing, Global Pharmacovigilance, Global Project Management, Global IP, Global Business Services (GBS) RA, RA-PLCM and provincial authorities to ensure that regulatory submissions are prepared, submitted and approved in a timely and efficient manner.  

Job Responsibilities

• Compiles, submits, and manages through to approval, provincial regulatory submissions for the assigned products to ensure timely formulary listings aligned with planned market launches for new products or life cycle management of marketed products.  • Reviews work conducted by team members to ensure accuracy, quality & compliance of information to facilitate timely approval and/or formulary listings, as applicable.  • Works with other functional areas to resolve issues related to the coordination of information for submissions, deficiency responses, etc.  • Develops, or supports other cross-functional areas (e.g. Commercial Operations) in developing, effective regulatory strategies  leading to seamless approval/formulary listing of products to align with planned market launches.  • Evaluates issues/problems in regulatory filings, approvals or formulary listings, proposes solutions and implements action plans, informing and escalating as appropriate.  • Provides leadership and training to team members to support the balanced growth of individuals and the development of the team as a whole. Provides feedback to the Manager regarding performance of staff.  • Coaches/mentors staff in the preparation of quality submissions, and other functional tasks.  • Performs other duties as assigned by Manager, Regulatory Affairs.  • Acts as a designate to the Manager as required.  

Job Requirements

Knowledge, Skills and Abilities

  • Excellent oral/written communication, leadership, organizational and interpersonal skills.
  • Computer literate. Familiarity with IT systems, e.g. databases and various software packages.
  • Experience in leading a team of professionals would be an asset.

Experience

  • Minimum five years experience in the pharmaceutical industry with at least three years experience in senior Regulatory Affairs role.

 

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.   Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

 

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More Information

Posted

Post Expires

Type

Mid-level industry position

North%20York%2C%20Canada

North York , Canada