Coordinator, Regulatory Affairs
Job Description

Are you looking to make a difference in a patient’s life?  At Innomar Strategies, a company of AmerisourceBergen, you will find an innovative culture that is patient focused and dedicated to making a difference.  As an organization, we are united in our responsibility to create healthier futures.


The Coordinator, Regulatory Affairs reports directly into the Senior Consultant, Regulatory Affairs and has the responsibility for supporting the development of Health Canada and Food and Drug Administration submissions and other tasks as assigned. The role supports the members of the Regulatory team and works on specific projects and assigned tasks under supervision of their manager.

 
DUTIES AND RESPONSIBILITIES/EXPERIENCE:
  • Build and maintain a positive and productive liaison with internal and external contacts.
  • Develop professional regulatory and document knowledge and skills in order to provide effective consulting services.
  • Co-ordinate and compile regulatory submissions, responses to agency questions and other correspondence in accordance with requirements for assigned projects under supervision
  • Implement an agreed upon action plan to achieve timely approval of regulatory submissions which ensure compliance with applicable regulations, policy and guidance under supervision.
  • With support of manager, effectively prioritize, coordinate and complete projects within established timeframes as assigned.
  • Ensure electronic filing of submissions / documents / data are maintained and kept up-to-date.
  • Responsible for the quality control of documents and / or data, as required.
  • Participation in cross functional teams for assigned projects
  • Responsible for completion of other activities in support of regulatory team as assigned



  • B.Sc. (life sciences disciplines strongly preferred) or equivalent training and related experience. Advanced degree in related field is preferred

 MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

  • Direct experience and working knowledge of a wide range of regulatory submission types an asset.
  • Effective project management skills; attention to detail
  • Demonstrated strategic planning and problem-solving skills.
  • Time management and multi-tasking skills.
  • Effective interpersonal skills
  • Ability to consistently meet deadlines
  • Demonstrated ability to work in a cross-functional, multidisciplinary team environment.
  • Knowledge of Microsoft Word, Excel, PowerPoint and the other Office Programs
  • Excellent written and verbal communication skills 


We offer competitive total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.

  • Competitive compensation packages
  • Comprehensive health and dental plans
  • Flexible & remote working options
  • Employer RRSP-matching
  • Online peer-to-peer recognition program
  • Corporate discounts with multiple establishments, including fitness centers
  • Health & Wellness program with onsite yoga and massage therapy

AmerisourceBergen is a publicly traded Fortune 10 global healthcare solutions company and is one of the world's largest pharmaceutical services companies. Powered by our associates around the world, we provide pharmaceutical products and business solutions that improve access to care.  We operate the backbone of the healthcare supply chain. We drive the future of local care delivery.  We guide medical innovations to market.  We create healthier futures.



Job Requirements

 

Company Overview

Innomar Strategies was founded in 2001 around the kitchen table of our current president, Guy Payette, and his partners. The company originally specialized in market access and reimbursement consulting, and gradually expanded its capabilities to include fully integrated patient support programming, nursing support, and specialty logistics. By the end of 2008, the company had grown to have over 450 associates.

In 2009, AmerisourceBergen acquired Innomar Strategies further establishing the company’s expertise in specialty pharmaceuticals. As part of AmerisourceBergen, Innomar Strategies is connected with a global leader in healthcare with over $135 billion of annualized revenue and 18,000 associates. AmerisourceBergen has an established history of delivering innovative programs and solutions across the pharmaceutical supply channel.

With over 1,200 associates and a nationwide footprint, Innomar Strategies is Canada’s leading service provider to specialty pharmaceutical and biotech manufacturers. Innomar is differentiated by their Integrated Service Model, which provides customized solutions to improve product access, increase supply chain efficiency, and enhance patient care. Manufacturers trust Innomar Strategies to deliver innovative brand solutions throughout the product lifecycle.