Director, 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 Director, Regulatory Affairs reports directly into the Director/Senior Director, Regulatory Affairs and  participates as a member of the management team to direct and manage a team of consultants to build and maintain a positive and productive liaison with internal and external customers.  They act as a primary contact for clients responsible for maintaining client relationships, including work on and oversight of client projects and services, quoting, and invoice reconciliation. They are responsible for leading a number of regulatory initiatives and  will interact cross-functionally to support Innomar teams. They will serve as the principal interface with health authorities and manage the strategies and execution of these interactions.

 

DUTIES AND RESPONSIBILITIES/EXPERIENCE:

  • Participates as a member of the management team as required to direct and manage the affairs of the company.
  • Provides support to generate new business for TPIreg and broader Innomar team as applicable while maintaining assigned billable targets.
  • Participates in professional activities such as industry training, conference presentations, publications, webinars as applicable
  • Builds and maintains a positive and productive liaison with internal and external contacts, including interfacing with clients/agencies/professional associations as applicable.
  • Acts as primary contact for clients with responsibility for maintaining client relationships, including quoting, invoice reconciliation and provision of client services.
  • Responsible for the overall management of key accounts to ensure compliance with client internal review processes and  required external approvals.
  • Develops and maintains partnerships with senior decision-makers in all departments to effectively achieve business results
  • Manages multiple simultaneous projects to ensure that  they are on budget, meet timelines and  client expectations.
  • Analyzes data, the regulatory environment and business objectives to recommend priorities
  • Provides teams with direction on regulatory authority interactions while ensuring cross-functional perspectives and expertise are incorporated into regulatory plans
  • Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams
  • Provides regulatory intelligence
  • Engages in continuous learning activities in order to provide effective consulting services.
  • Develops, mentors and manages  direct reports and other members of the team as applicable assigning work and guiding use of consulting resources to deliver a value service offering  while supporting development of staff knowledge and skills.
  • Other related duties as assigned
  • B.Sc. required (life sciences disciplines strongly preferred)
  • Advanced Degree in related field is preferred
  • 12 years of relevant experience in regulatory affairs or related functions in pharmaceutical/biologic/medical device development/manufacturing
  • Prior consulting experience preferred
  • Regulatory Affairs Certification (RAC) and other certifications such as Quality or Clinical Research are an asset.
 MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
  • Superior project and people management/mentorship skills to manage multiple concurrent projects within established timelines in a dynamic environment.
  • Demonstrated strategic planning and complex problem-solving skills to ensure service value offering
  • Ability to drive results in a team environment.
  • Demonstrated senior leadership abilities in a cross-functional, multi-disciplinary team environment.
  • Direct experience with and working knowledge of a wide range of regulatory submission types.
  • Broad understanding of international regulations, processes and issues in drug/biologics/medical device development. Includes sound knowledge of ICH, Health Canada, FDA, EMA, and other relevant guidelines with focus in area of specialization such as biologics, pharmaceuticals or medical devices. 
  • In depth experience of successfully managing Health Authorities interactions on a regional basis
  • Effective organizational skills and attention to detail
  • Ability to develop professional networks that will drive business development and regulatory intelligence
  • Strong business and financial acumen
  • Strong analytical and mathematical skills
  • Ability to communicate effectively both orally and in writing.
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat

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.