Manager of Regulatory Affairs

Cencora; British Columbia; On-site; CAD 85,000 - 110,000; Full time

Job summary

A leading company in healthcare is seeking a Manager of Regulatory Affairs. This role involves coordinating regulatory submissions, engaging with clients and agencies, and ensuring compliance with health authority regulations. The ideal candidate will have a strong background in life sciences and regulatory affairs, with excellent communication and organizational skills. Join us to make a meaningful impact on health and improve lives worldwide.

Qualifications

• 5+ years of Regulatory Affairs or related experience in healthcare.
• Experience with regulatory submissions and local health authority regulations.

Responsibilities

• Coordinate regulatory submissions and responses for projects.
• Build relationships with clients and agencies.
• Monitor projects to meet budgets and timelines.

Skills

Time Management

Problem Solving

Effective Communication

Organizational Skills

Education

B.Sc. in Life Sciences

Certification in Regulatory Affairs (RAC)

Tools

Adobe Acrobat

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Join to apply for the Manager of Regulatory Affairs role at Cencora .

Our team members are at the heart of everything we do. At Cencora, we are committed to creating healthier futures and every person here is essential to that purpose. If you want to make a difference in health, join our innovative company and help improve lives worldwide. Apply today!

Primary Duties And Responsibilities

• Coordinate and compile regulatory submissions, responses to agency questions, and other correspondence for assigned projects, applying intermediate regulatory practice knowledge.
• Participate in cross-functional teams to support regulatory strategies and achieve business results.
• Identify client and dossier issues, develop strategies to address them, and consult as needed.
• Build and maintain positive relationships with internal and external contacts, including clients and agencies.
• Prioritize and monitor projects to meet budgets, timelines, and client expectations; review invoices; ensure quality and control of documents following SOPs and best practices.
• Maintain and expand regulatory knowledge to provide effective consulting services.
• Support client proposals and new business activities as assigned.
• Travel as necessary; passport required.

Experience And Educational Requirements

• B.Sc. in Life Sciences (Microbiology, Biology, Chemistry, or Pharmacy) or extensive relevant experience and training; advanced degree preferred.
• Certification in Regulatory Affairs (RAC) and other relevant certifications an asset.
• Prior consulting experience is an asset.
• 5+ years of Regulatory Affairs or related experience within healthcare products or consulting.

Minimum Skills, Knowledge, and Abilities

• Experience with a range of regulatory submission types.
• Strong knowledge of local health authority regulations and policies.
• Effective time management and multitasking skills.
• Strategic planning and problem-solving skills.
• Business and financial acumen.
• Analytical and mathematical skills.
• Organizational skills and attention to detail.
• Ability to meet deadlines consistently.
• Effective communication skills, both oral and written.
• Ability to work in cross-functional teams.
• Proficiency with Adobe Acrobat, Microsoft Word, Excel, and Outlook.

The role involves daily contact with English-speaking clients, patients, or peers from cross-disciplinary teams.