Manager, Regulatory Affairs

Innomar Strategies; New Brunswick; Hybrid; CAD 80,000 - 110,000; Full time

Job summary

A leading company in healthcare is seeking a Regulatory Affairs professional to coordinate regulatory submissions and support cross-functional teams. The ideal candidate will have a B.Sc. in Life Sciences and over 5 years of relevant experience. Join us to make a difference in health and wellness.

Benefits

Medical, dental, and vision care

Comprehensive wellness programs

Paid parental leave

Professional development resources

Qualifications

• 5+ years of experience in Regulatory Affairs or related field.
• B.Sc. in Life Sciences or equivalent experience.
• Certification in Regulatory Affairs is an asset.

Responsibilities

• Coordinate regulatory submissions and responses.
• Participate in cross-functional teams to support strategies.
• Identify and address client and dossier issues.

Skills

Regulatory submission types

Health Authority regulations

Time management

Strategic planning

Problem-solving

Analytical skills

Organizational skills

Communication skills

Teamwork

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 practice.
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 liaison with internal and external contacts, including interfacing with clients and agencies.
5. Prioritize and monitor assigned projects to meet budget (including invoice review), timelines, and client expectations; identify and communicate emerging issues. Follow Innomar and client best practices and SOPs to ensure quality and control of documents. Support other related duties as assigned and maintain and expand professional regulatory knowledge to provide effective consulting services.
6. Support client proposals and new business activities as assigned.
7. Ability to 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 related 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 relevant experience within the healthcare products industry or consulting.

Skills, Knowledge, and Abilities:

• Direct experience and working knowledge of a wide range of regulatory submission types.
• Strong working knowledge of local Health Authority regulations, guidelines, and policies.
• Effective time management and multi-tasking skills.
• Strategic planning and problem-solving skills to resolve issues effectively and efficiently.
• Strong 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 effectively in a cross-functional, multi-disciplinary team environment.
• Proficiency with computers, including 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 traditional benefits like medical, dental, and vision care, as well as comprehensive wellness programs addressing physical, emotional, financial, and social well-being. This includes support for working families, such as backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. We also promote personal growth through training programs, professional development resources, mentorship opportunities, employee resource groups, volunteer activities, and more.