Director, Regulatory Affairs in Oakville at Innomar Strategies

Date Posted: 10/24/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Oakville
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    10/24/2019

Job Description

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

Job Requirements

  • 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