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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
People Leader
All Job Posting Locations:
Markham, Ontario, Canada
Job Description:
Johnson and Johnson is recruiting for a(n) Associate Director, Regulatory Affairs Electrophysiology and Vision, located in Markham, Ontario, Canada.
Reporting into the Director, Regulatory Affairs, G5/CAN Cardio responsible for leading and executing regulatory activities to obtain and maintain RA registration status in compliance with Canadian laws and regulations, as well as corporate policies and procedures. The Assoc. Director, Regulatory Affairs, as a leader within the Canadian RA organization, develops and implements regulatory strategies to meet project deliverables. As a subject matter authority for Regulatory Affairs, provides guidance to local and global business partners.
Key Responsibilities:
- Lead and mentor a group of regulatory professionals to deliver business objectives in close collaboration with local and global teams.
- Support the building of a Regulatory Affairs talent pipeline through the selection and development of regulatory professionals, in partnership with regulatory leadership.
- Conduct analysis and risk assessment of pipeline projects, develop successful regulatory strategies to achieve desired business outcomes. Escalate as appropriate high-impact risks.
- Lead the preparation and compilation of regulatory submissions for new and amended products, investigational testing and ad hoc reports to Health Canada and maintain the life cycle of currently marketed products.
- Manage the preparation and review of responses to Health Canada queries in a timely manner.
- Lead interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval, optimal labelling and implementation of local regulatory strategies.
- Collaborate with global regulatory teams to facilitate regulatory activities within the established global framework.
- Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities.
- Develop effective working relationships with business partners as well as opinion leaders as needed.
- Handle emerging issues and associated risk communications to stakeholders.
- Provide regulatory guidance to internal collaborators on messaging and promotional material review.
- Monitor the regulatory environment, interpret changes, analyze gaps and conduct impact assessments
- Influence and shape Health Canada policies to create a supportive regulatory environment for pipeline products.
- Actively contribute to improving critical departmental processes and initiatives to enhance the internal work environment.
Qualifications
Education:
- Bachelor’s Degree; Biological or related sciences field of study desired.
- Advanced Degree preferred.
Experience and Skills:
**Required: **
- At least 8+ years of relevant Regulatory Affairs or related experience required.
- Solid understanding of Canadian laws, regulations, guidelines and policies, and the Health Canada organizational structure and processes for the review and approval of health product submissions required.
- Strong working knowledge of Canadian regulatory submission requirements required.
- Previous people leadership experience is required.
Preferred:
- Understanding of the application of laws, regulations, guidance’s and policies to specific projects.
- Ability to interpret and understand Regulations in the context of the scientific and commercial environment.
- Ability to interpret, summarize and communicate clinical data.
- Well-defined problem solving and analytical skills with demonstrated ability to think strategically.
- Strong negotiation and influencing skills.
- Well-developed project management skills and ability to manage multiple priorities.
- Strong communication skills, both verbal and written.
- Well-developed interpersonal, team and leadership skills to facilitate teamwork and problem-solving.
- People supervisory and coaching skills.
- Excellent customer and marketplace focus.
Other:
- Proficiency in English required
- Up to 10% domestic and international travel
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
**Required Skills: **
Preferred Skills:
Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Managing Managers, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking