Head, Regulatory Affairs, North America
6 months ago
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 America-specific 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 site-specific 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/bid-defense 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.
-
Senior Medical Affairs Manager
2 weeks ago
Toronto, Ontario, Canada Brunel Full time**Clinical and Medical Affairs Manager Opportunity in Toronto, ON**Brunel is proud to present a challenging role for a Clinical and Medical Affairs Manager at a leading Canadian company specializing in dermal fillers.As a key member of the medical affairs team, you will be responsible for ensuring compliance with regulatory requirements (SOPs, GCPs, FDA,...
-
Medical Affairs Director, North America
1 week ago
Toronto, Ontario, Canada Brunel Full timeWe are seeking a highly skilled Clinical and Medical Affairs Manager to join our team in Toronto, ON.About the RoleThe ideal candidate will have extensive experience in clinical trials management, regulatory compliance, and medical affairs activities. They will be responsible for ensuring full compliance with regulations, managing clinical trials, and...
-
Eataly North America Marketing Liaison
4 weeks ago
Toronto, Ontario, Canada Eataly North America Full timeMarketing Liaison Opportunity at Eataly North AmericaWe are seeking a highly motivated and experienced Marketing Liaison to join our team at Eataly North America. As a Marketing Liaison, you will play a critical role in supporting the execution of marketing plans across our Toronto locations.About Eataly North AmericaEataly North America is a leading retail...
-
Senior Corporate Counsel for North America
4 weeks ago
Toronto, Ontario, Canada IKO North America Full timeIKO North America is a leading manufacturer of roofing and building materials. As the General Counsel, you will play a key leadership role in overseeing all legal matters and providing expert advice to senior management on legal issues impacting the company.The ideal candidate will have 8-10 years of commercial real estate and general corporate/commercial...
-
Dish Creator at Eataly North America
4 weeks ago
Toronto, Ontario, Canada Eataly North America Full timePizza Maker Position SummaryWe are seeking a skilled and enthusiastic Dish Creator to join our team at Eataly North America. As a Pizza Maker, you will be responsible for producing high-quality pizzas in accordance with our authentic Italian recipes.Job DescriptionThe successful candidate will have experience working in a back-of-house production...
-
Regulatory Affairs Associate
6 months ago
Toronto, Canada Translational Research in Oncology Full timeTranslational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. TRIO is looking for a **Regulatory Affairs** **Associate to** join...
-
Eataly North America Sales Team Member
4 weeks ago
Toronto, Ontario, Canada Eataly North America Full timeJob Title: Eataly North America Sales Team MemberWe are seeking a highly skilled and enthusiastic Sales Team Member to join our dynamic team at Eataly North America. This role is perfect for individuals who have a passion for delivering exceptional customer service, working in a fast-paced environment, and promoting Italian culture.About the Job:This is a...
-
Old Toronto, Canada LUSH Full timeLush is seeking a highly skilled Regulatory Affairs Manager to join our team in Toronto, Ontario. This 18-month full-time contract role will play an essential part in growing talent within the business and ensuring regulatory compliance.The ideal candidate will have a minimum of 7+ years' experience in the Regulatory Affairs functions of a...
-
Head of Production, North America
6 months ago
Toronto, Canada Southern Graphics Systems, Canada Co. Full time**Role** We are looking for an integrated Head of Content Production to oversee our North America studios. A process-led leader with experience mentoring and overseeing a team of producers in a fast-paced creative agency environment. An astute commercial thinker, capable of quickly assessing a request to identify risks and opportunities. A proactive problem...
-
Regulatory Change Lead
2 weeks ago
Toronto, Ontario, Canada Hunter Bond Full timeAt Hunter Bond, we are currently seeking a highly motivated and experienced individual to lead the implementation of regulatory change projects across North America.About the RoleThe successful candidate will work closely with global stakeholders to deliver change initiatives that meet new regulatory requirements, addressing the regulatory aspects of new...
-
Regulatory Affairs Manager
6 months ago
Toronto, Canada Porsche Cars Canada Full timeIf you make hearts beat faster, your own has to be in the right place. **Regulatory Affairs Manager**: - **Code number**:J000010515 - **Entry level**:Professionals - **Location**:Toronto - **Organization**:Porsche Cars Canada **Tasks **Tasks**Tasks*** **Position Overview** The Regulatory Affairs Manager is responsible for providing internal expertise...
-
Regulatory Affairs Coordinator
1 month ago
Toronto, Ontario, Canada Deciem Full timeWe are seeking an experienced Regulatory Affairs professional to support the product registrations and commercial expansion of our existing and new brands. This role will be based out of our Head Office in Liberty Village and offers a hybrid work schedule.The successful candidate will assemble registration dossiers, create labels, and coordinate...
-
Regulatory Affairs Expert
2 weeks ago
Old Toronto, Canada Lush Group Full timeThe Regulatory Affairs Manager plays a pivotal role in driving growth and development within our business by collaborating with the Product Team and sharing best practices. As a growing company, we need individuals who can adapt to our evolving needs, analyze requirements, and respond accordingly.Our staff live with purpose, finding personal value...
-
Head of Talent Acquisition for North America
4 weeks ago
Toronto, Ontario, Canada CB Canada Full timeJob Title: Head of Talent Acquisition for North AmericaWe are seeking a seasoned Recruiter to lead our full lifecycle recruitment efforts in the Alcohol Industry. As a key member of our team, you will be responsible for implementing talent acquisition strategies to identify, attract, and hire high-quality talent across Pernod Ricard.About the Role:Partner...
-
Head of Regulatory Affairs
2 weeks ago
Toronto, Canada Tether Operations Limited Full timeSince its inception in 2014 by pioneering Bitcoin enthusiasts, Tether has not only launched the first 'stablecoin', USD₮, but also expanded its horizons into Tether Data, Tether Power, Tether Edu, and more. Our platforms and tokens lead in liquidity, stability, and innovation, setting the foundation for the future. Tether is committed to the...
-
Regulatory and Clinical Affairs Manager
1 week ago
Toronto, Ontario, Canada Brunel Full timeAbout the RoleWe are seeking an experienced Regulatory and Clinical Affairs Manager to join our team in Toronto, ON. As a key member of our medical affairs department, you will play a vital role in ensuring compliance with regulations, managing clinical trials, and evaluating investigational sites in North America.Key ResponsibilitiesEnsure adherence to...
-
Aircraft Regulatory
2 weeks ago
Old Toronto, Canada LUSH Full timebr/>Job Type: 18 month, full-time contract role. br/>Job Location: Must be located in Toronto, Ontario or surrounding areas. This is a hybrid role with 2-3 days/week required onsite.Canadian Working Eligibility: Successful candidate must be eligible to work in Canada/eligible to obtain an appropriate working visa for Canada.The Regulatory Affairs Manager...
-
Old Toronto, Canada Hunter Bond Full timeEstablished banking institution Hunter Bond is seeking a seasoned leader to oversee the implementation of regulatory change projects and initiatives across North America. In this pivotal role, you will collaborate with global stakeholders to deliver transformative changes that address new regulatory requirements and support the growth of new business...
-
Regional Head of Facilities North America
6 months ago
Toronto, Canada Computershare Full time**Location: Toronto (On-site)** **We give you a world of potential** We’re committed to your flexibility and wellbeing. You’ll experience this through our supportive approach, continuous learning opportunities, empowerment in your role and the ability to balance work and life. Find out more about our culture of flexible working. **A role you will...
-
Communications Manager, Canada
6 months ago
Toronto, Canada Foreign & Commonwealth Office Full timeJob Description (Roles and Responsibilities) 1 Be part of the Department for Business and Trade's (DBT) mission to drive more trade and investment between North America and the UK. With a mature, high-spending consumer market, an open, liberal economy, world-class talent, and a business-friendly regulatory environment, the UK is the leading destination for...