Head, Regulatory Affairs, North America - Toronto, Canada - PSI CRO

PSI CRO

Verified Company

Toronto, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Company Description

We're over 2,700 strong across the globe. We're scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for Teamwork across all our business. We love the challenge of our industry. We're changing lives and redefining success every step of the way.

You are dynamic. You are curious. You are more than your job. For you, excellence isn't just a word; it's the measure for all you do. You're passionate. Driven. Dedicated. You can't stand mediocrity. And you might be the team member we're looking for.

Job Description:

Department Management

Management of the Regulatory Affairs staff in North America
Primary responsibility for establishing operational objectives and performance goals for the Regulatory Affairs staff in North America
Primary responsibility for the allocation of Regulatory Affairs resources and resolution of resourcing conflicts in North America
Hiring and dismissal of the Regulatory Affairs staff in North America
Performance appraisal of the Regulatory Affairs staff in North America
Oversight of the departmental staff's career development in North America
Development and implementation of training programs for the Regulatory Affairs staff in North America
Interaction with other company departments in North America

Quality Control and Quality Assurance

Development and implementation of quality systems within Regulatory Affairs in North America (shared responsibility)
Development and implementation of quality controls within Regulatory Affairs in North America
Development of quality systems documents within the functional area for North America (shared responsibility)
Consulting Quality Management in North Americaspecific regulatory aspects during the development and implementation of internal audit plans (shared responsibility)
Participation in and facilitation of systems audits in North America (shared responsibility)
Participation in and facilitation of regulatory inspections in North America (shared responsibility)

Regulatory Affairs and Pharmacovigilance

Supervisory responsibility for the procurement of essential study documents and sitespecific documents required for regulatory and ethics committee submissions in North America from project teams
Primary responsibility for the preparation and review of regulatory and ethics committee submission dossiers in North America
Primary responsibility for tracking of regulatory project documentation flow in North America
Primary responsibility for tracking changes/amendments to legislative acts pertaining to clinical trials in North America and timely notification of all parties concerned
Shared responsibility for safety reporting in North America

Business Development / Feasibility

Primary contact for regulatory aspects of feasibility evaluation in North America
Participation in client/biddefense meetings, as required

Qualifications:

Bachelor's Degree required
A Life Sciences degree is a plus
Minimum 5 years of proven experience within Regulatory Affairs for clinical research
Prior experience in a managerial function (i.e. line management)
Extensive experience in regulatory aspects of clinical research with profound knowledge of regulations pertaining to clinical trials in North America
Strong attention to detail skills
Excellent communication and presentation skills
Ability to lead a team and present strong leadership capabilities

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.