Mgr, Regulatory Affairs Pharma - HealthCanada

Fresenius Medical Care AG; Waltham (MA); Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company in healthcare is seeking a Regulatory Affairs expert to manage pharmaceutical products and ensure compliance with Canadian regulations. This fully remote role involves authoring submissions, leading staff, and developing regulatory strategies. The ideal candidate will have extensive knowledge of Canadian regulations and experience in managing relationships with regulatory agencies.

Qualifications

• Subject matter expert in Regulatory Affairs related to Health Canada.
• Extensive knowledge of applicable government regulations in Canada.

Responsibilities

• Authoring and coordinating submissions to regulatory agencies.
• Managing Regulatory Pharmaceuticals staff and developing their expertise.
• Building relationships with regulatory agencies like the FDA.

Skills

Regulatory Affairs

Leadership

Communication

Job description

This is a fully remote position. The ideal candidate should be a subject matter expert in Regulatory Affairs related to Health Canada. The role involves providing regulatory input to facilitate the timely preparation and submission of required information to relevant agencies, specializing in Canadian regulatory affairs. The candidate will manage the company's pharmaceutical products with a focus on Canadian Regulatory Affairs, develop regulatory strategies, and advise departments on product design, development, evaluation, and marketing in Canada.

Responsibilities include:

1. Authoring, reviewing, and coordinating quality submissions to regulatory agencies such as Health Canada.
2. Maintaining extensive knowledge of applicable government regulations in Canada.
3. Ensuring overall regulatory compliance for FMCNA pharmaceutical products.
4. Managing Regulatory Pharmaceuticals staff and developing their expertise.
5. Responding to requests from FDA or district offices.
6. Serving as a regulatory representative on Product Development Teams, providing support and advice.
7. Facilitating regulatory and clinical strategy development, including approval strategies.
8. Assisting in schedule planning for product development.
9. Building relationships with regulatory agencies like the FDA.
10. Providing leadership, coaching, and performance feedback to staff.
11. Ensuring timely FDA commitments and regulatory submissions.
12. Preparing for and managing meetings with regulatory agencies, including documentation and follow-up.
13. Liaising with Regulatory Operations for submission processes.
14. Providing ongoing regulatory education and guidance to staff and subcontractors.
15. Supporting various projects and departmental functions as assigned.