Manager, Regulatory Affairs

Innomar Strategies; Ontario; Hybrid; CAD 60,000 - 100,000; Full time

Job summary

An innovative company is seeking a Regulatory Affairs Specialist to join their dynamic team. This role involves coordinating regulatory submissions and ensuring compliance with health authority regulations while fostering collaborative relationships with clients and internal teams. You will leverage your expertise to identify and resolve issues, support strategic planning, and contribute to business success. The company values its team members and offers a culture of inclusivity along with comprehensive benefits to support personal and professional growth. If you're passionate about making a difference in the healthcare industry, this opportunity is for you.

Benefits

Medical, Dental, and Vision Care

Comprehensive Wellness Programs

Paid Parental Leave

Professional Development Resources

Mentorship Opportunities

Employee Resource Groups

Volunteer Activities

Adoption Assistance

Infertility Coverage

Backup Dependent Care

Qualifications

• 5+ years of experience in Regulatory Affairs or related fields.
• Advanced degree in Life Sciences preferred or equivalent experience.

Responsibilities

• Coordinate regulatory submissions and responses to agency questions.
• Build positive relationships with clients and internal teams.
• Monitor projects to meet budgets and timelines.

Skills

Regulatory Submission Types

Health Authority Regulations

Time Management

Strategic Planning

Problem-Solving

Analytical Skills

Communication Skills

Organizational Skills

Education

B.Sc. in Life Sciences

Certification in Regulatory Affairs (RAC)

Tools

Adobe Acrobat

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Responsibilities:

1. Coordinate and compile regulatory submissions, responses to agency questions, and other correspondence in accordance with requirements for assigned projects, applying intermediate knowledge of regulatory practices.
2. Participate in cross-functional teams to support regulatory strategies and help achieve business results.
3. Identify client and dossier issues and develop effective strategies to address them, consulting with others as needed.
4. Build and maintain positive and productive relationships with internal and external contacts, including interfacing with clients and agencies.
5. Prioritize and monitor assigned projects to meet budgets (including invoice review), timelines, and client expectations; identify and communicate emerging issues. Follow Innomar and client SOPs to ensure document quality and control. Maintain and expand professional regulatory knowledge to provide effective consulting services.
6. Support client proposals and new business activities as assigned.
7. Travel as necessary; passport required.

Experience and Educational Requirements:

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

Skills, Knowledge, and Abilities:

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

What Cencora Offers:

We provide compensation, benefits, and resources that foster an inclusive culture and support our team members’ purpose-driven lives. Our offerings include medical, dental, and vision care, along with comprehensive wellness programs addressing physical, emotional, financial, and social health. We support working families through backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To promote personal growth, we offer training programs, professional development resources, mentorship opportunities, employee resource groups, volunteer activities, and more.