Manager, Regulatory Affairs

Manager, Regulatory Affairs

Remote, Ontario, Canada

Remote, Manitoba, Canada

Category:Consulting

widget:Full time

Manager, Regulatory Affairs- CMC

Primary Duties and Responsibilities:

 

• Co-ordinate and compile regulatory submissions, responses to agency questions and other correspondence in accordance with requirements for assigned projects
• Implement an agreed upon action plan to achieve timely approval of regulatory submissions which ensure compliance with applicable regulations, policy and guidance.
• Participate in and support project teams
• Effectively prioritize, coordinate and complete multiple projects within established timeframes.
• Identify client and dossier issues and develop effective strategies to address them consulting with others as needed.
• Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with clients/agencies.
• Pro-active project management skills to ensure that assigned projects meet budget / quote timelines and client expectations;
• Responsible for the quality control of documents and / or data, as required.
• Responsible for completion of other activities in support of products and processes as assigned
• Maintain and expand professional regulatory knowledge (Health Canada and FDA) in order to provide effective consulting services.
• Support of client proposals and new business activities as needed.
• Train or mentor others to build team expertise.
• Proactively improve business process and tools to expedite core services.
• Ability to travel as necessary, passport required.
• Responsible for preparation of CMC documentation to Health Canada and FDA

 

Experience and Educational Requirements:

• B.Sc. (advanced degree preferred) in Life Sciences (Microbiology, Biology, Chemistry or Pharmacy preferred) or extensive equivalent experience and related training.
• Certification in Regulatory Affairs (RAC) and /or Prior consulting experience an asset.
• 5 - 8 years Regulatory Affairs or related relevant experience within the health care products industry, or consulting.

Minimum Skills, Knowledge and Ability Requirements:

• Direct experience and working knowledge of a range of health care products (Biologics, Therapeutics, Natural Health Products, Cosmetics)
• Strong working knowledge of local Health Authority regulations, guidelines and policies
• Maintenance of work processes in line with customer needs and expectations.
• Well organized, time management and multi-tasking skills.
• Effective project management skills.
• Excellent problem-solving skills; ability to resolve issues effectively and efficiently
• Strong business and financial acumen
• Strong analytical and mathematical skills
• Self-motivated and proactive Effective organizational skills; attention to detail
• Ability to consistently meet deadlines
• Excellent interpersonal, verbal and written communication skills.
• Demonstrated ability to work in a cross-functional, multi-disciplinary team environment.
• Proficient with software applications (MS Office, Adobe Professional, Veeva Vault).

 

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

Full time