Associate Director, Regulatory Affairs

7 days ago

Old Toronto, Ontario, Canada Johnson & Johnson Full time
Johnson & Johnson Innovative Medicine is recruiting for an Associate Director, Regulatory Affairs to be located in Toronto, Ontario under the flexible working model (at least 3 days in office).

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The Associate Director, Regulatory Affairs will be responsible for supporting regulatory activities to obtain and maintain drug product registration status in compliance with Canadian drug laws and regulations, as well as corporate policies and procedures. The Associate Director will help develop and implement regulatory strategies to meet project deliverables, both as a member of a team, and in leading others. As a subject matter authority for Regulatory Affairs, the individual will provide 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
  • Conduct analysis and risk assessment of pipeline projects, develop successful regulatory strategies to meet business results
  • Lead the preparation and compilation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), Notifiable Changes (NCs), 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 (e.g. Clarifax, Notice of Non-Compliance (NON), and Notice of Deficiency (NOD)) 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 and the Global Regulatory Affairs (GRA) function/teams to facilitate regulatory activities
  • Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities
  • Develop effective working relationships with opinion leaders as needed
  • Handle emerging issues (e.g. new safety or quality finding) and associated risk communications to stakeholders
  • Provide regulatory guidance to internal collaborators on messaging, promotional material review, and PAAB responses
  • Monitor the regulatory environment, interpret changes, analyze gaps and conduct impact assessments
  • Shape Health Canada policies to pave a favorable regulatory environment for pipeline products
  • Actively contribute to improving critical departmental processes and to initiatives to enhance the internal work environment
  • Minimum B.Sc. in Biological or related sciences.
  • Advanced degree preferred.
  • 5 years Regulatory Affairs pharmaceutical or related experience is required.
  • Strong working knowledge of the drug development process is required.
  • Solid understanding of Canadian drug laws, regulations, guidelines and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions is required.
  • Understanding of the application of laws, regulations, guidances and policies to specific projects is required.
  • Ability to interpret and understand Regulations in the context of the scientific and commercial environment is required.
  • Strong scientific writing skills is required.
  • Ability to interpret and summarize clinical data is required.
  • Well-defined problem solving and analytical skills is required.
  • Well-developed project management skills and ability to manage multiple priorities is required.
  • Excellent communication (oral and written) and strong interpersonal skills is required
  • Strong negotiation and influencing skills is required.
  • Well-developed team skills is required.
  • Excellent customer and market place focus is required.
  • Demonstrated ability to think strategically is required.
  • People supervisory and coaching skills is required.
  • Well-developed interpersonal and leadership skills to facilitate teamwork and problem-solving is required.
  • This role is to be located in Toronto and will require up to 10% travel.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .)

This job posting is anticipated to close on 6/30/24. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.
#J-18808-Ljbffr

  • Associate Director, Regulatory Affairs

    1 week ago

    Toronto, Ontario, Canada Johnson & Johnson Full time

    Johnson & Johnson Innovative Medicine is recruiting for an Associate Director, Regulatory Affairs to be located in Toronto, Ontario under the flexible working model (at least 3 days in office).For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day....

  • Director Regulatory Affairs

    1 week ago

    Toronto, Ontario, Canada Canadian Imperial Bank of Commerce Full time

    Director, Global Regulatory Affairs page is loaded Director, Global Regulatory Affairs Apply locations Toronto, ON time type Full time posted on Posted 2 Days Ago job requisition id We're building a relationship-oriented bank for the modern world. Global Regulatory Affairs (GRA) is CIBC's central point-of-contact with global prudential regulators. The...

  • Director, Regulatory Affairs

    1 week ago

    Toronto, Ontario, Canada Yorkville University Full time

    About Us:The same philosophy of personal attention that distinguishes Yorkville Education Company as a leading provider of post-secondary education makes us an exceptional place to work. We are a progressive and modern institution, responding to the needs of current and future students and implementing the best technology solutions to empower our work. We...

  • Associate Director Quality Assurance

    7 days ago

    Old Toronto, Ontario, Canada Scientific Search Full time

    Associate Director – Quality Assurance & Regulatory AffairsLocation: Toronto, OntarioSummary: Embrace an essential leadership position within a leading pharmaceutical organization dedicated to groundbreaking scientific progress. As the Associate Director of Quality Assurance & Regulatory Affairs, your primary responsibility is to maintain

  • Regulatory Affairs Associate

    1 week ago

    Toronto, Ontario, Canada Medison Pharma Full time

    Medison is a global pharma company on a mission to help patients around the world get faster access to lifesaving, innovative, breakthrough therapies. We operate in 4 continents and over 24 countries and are growing fast. If you want to be part of our mission and help save patients by getting them the latest treatments, join usIn your role as regulatory...

  • Associate Director Quality Assurance

    1 week ago

    Old Toronto, Ontario, Canada Scientific Search Full time

    Associate Director – Quality Assurance & Regulatory Affairs Location: Toronto, OntarioSummary: Join a pivotal leadership role at a top-tier pharmaceutical company focused on pathbreaking scientific advancements. As an Associate Director of Quality Assurance & Regulatory Affairs, you will ensure compliance with Health Canada's stringent standards,...

  • Associate Director Quality Assurance

    1 week ago

    Old Toronto, Ontario, Canada Scientific Search Full time

    Associate Director – Quality Assurance & Regulatory AffairsLocation: Toronto, OntarioSummary: Join an essential leadership position at a top-notch pharmaceutical company dedicated to pioneering scientific advancements. As an Associate Director of Quality Assurance & Regulatory Affairs, you will ensure adherence to Health Canada's rigorous standards,...

  • Regulatory Affairs and Quality Specialist

    1 week ago

    Toronto, Ontario, Canada Ozmosis Research Inc. Full time

    JOB SUMMARYThe Quality Assurance & Regulatory Affairs Specialist (QARAS) supports the Senior Director of Quality Assurance & Regulatory Affairs (SDQARA) and the Ozmosis team in quality control/quality assurance and regulatory affairs.QUALIFICATIONSCompletion of a Bachelor's of Science degree or recognized equivalentExperience in Oncology, Clinical Trials,...

  • Regulatory Affairs Specialist

    1 day ago

    Toronto, Ontario, Canada ClinChoice Full time

    Regulatory Affairs Specialist - DEL at ClinChoice (View all jobs) Toronto, Canada Regulatory Affairs Associate Consultant - Canada Responsibilities: Responsible for new or post market support for local medical device/drug establishment license registrations (MDEL/DEL) and product license registrations Responsible for the documents review of product...

  • Associate Director, Regulatory Compliance

    1 week ago

    Toronto, Ontario, Canada Pharma Partners Recruitment Ltd Full time

    Job Title: Project Leader, Regulatory Affairs A Pharmaceutical business in Toronto, Canada is looking for a Project Leader, Regulatory Affairs to join their Global team. In this role you will Responsible for the Regulatory Affairs project management of development and marketed products. Provide regulatory strategic and operational input to local and global...

  • Vp, Regulatory Affairs

    7 days ago

    Toronto, Ontario, Canada Aviso Wealth Full time

    Aviso Wealth:The Opportunity:We're looking for a VP, Regulatory Affairs, to join our Compliance team.This role can be mostly remote, however we will on occasion require you to come onsite to our office at 151 Yonge St, Toronto, ON.Reporting to the Chief Compliance Officer, the VP, Regulatory Affairs is responsible for the enhancement and effectiveness of the...

  • Regulatory Affairs Consultant

    1 week ago

    Toronto, Ontario, Canada Toronto Hydro Full time

    WORK ILLUSTRATION:The incumbent is expected to behave ethically and follow the established code of business conduct, policies and internal control procedures, laws and regulations governing Toronto Hydro._Toronto Hydro has implemented a mandatory vaccination requirement for all its employees. Proof of full vaccination will be required upon receiving a...

  • Manager, Regulatory Affairs

    1 week ago

    Toronto, Ontario, Canada Biogen Full time

    Job Purpose:Reporting to Head, Regulatory Affairs, Canada. Contribute to the development and implementation of Canadian regional preclinical, clinical and CMC regulatory strategy for products in development and/or post NDS approval, in alignment with the Canadian business strategy.Responsibilities: Leading the planning, coordination and preparation of...

  • Regulatory Affairs Specialist

    1 week ago

    Toronto, Ontario, Canada Kelly Science, Engineering, Technology & Telecom Full time

    The Regulatory Affairs Specialist assists in managing Regulatory Licences (DEL, MDEL, and Site Licences); prepare product submission to Health Canada; perform product market release; and ensure clients are compliant with current and changing regulatory regulations. This position supports the develop

  • Quality Assurance

    1 month ago

    Toronto, Ontario, Ontario, Canada Ozmosis Research Inc. Full time

    I. JOB SUMMARYThe Quality Assurance & Regulatory Affairs Specialist (QARAS) provides support to the Senior Director of Quality Assurance & Regulatory Affairs (SDQARA) and Ozmosis team in quality control/quality assurance and regulatory affairs.II. QUALIFICATIONS• At minimum, completion of a Bachelor’s of Science degree or recognized equivalent•...

  • Quality Assurance

    3 weeks ago

    Toronto, Ontario, Ontario, Canada Ozmosis Research Inc. Full time

    I. JOB SUMMARYThe Quality Assurance & Regulatory Affairs Specialist (QARAS) provides support to the Senior Director of Quality Assurance & Regulatory Affairs (SDQARA) and Ozmosis team in quality control/quality assurance and regulatory affairs.II. QUALIFICATIONS• At minimum, completion of a Bachelor’s of Science degree or recognized equivalent•...

  • Regulatory Affairs Specialist Iii

    1 week ago

    Toronto, Ontario, Canada Zany Consulting Group Full time

    The Regulatory Affairs CMC Manager is supporting the regulatorysubmission activities of the Canadian Regulatory Affairs CMC group forvaccines.Responsibilities: Develops submission strategy and is responsible for managing all theregulatory CMC aspects throughout the life cycle of the assignedproduct/project. Authors the CMC sections (Modules 1, 2 and 3) of...

  • Regulatory Affairs Specialist

    1 week ago

    Toronto, Ontario, Canada Give and Go Prepared Foods Full time

    Give & Go Prepared Foods Corp. is part of the Mondelēz family and has been a leading North American manufacturer of baked goods for over 30 years. Now is the perfect time to join the Give & Go team as we are expanding rapidly, and we want you to be part of our bright future.Job Overview:The role of the Regulatory Affairs Specialist is to provide clear and...

  • Director of Public Affairs

    1 week ago

    Toronto, Ontario, Canada CCA - The Canadian Chiropractic Association Full time

    The Canadian Chiropractic Association (CCA) is a national profession-based healthcare association representing over 8000 chiropractors across Canada. The association works closely with the 10 provincial associations to promote the profession and build strong relationships with provincial and federal governments to ensure the growth and recognition of the...

  • Senior Corporate Communications and Public Affairs Specialist

    7 days ago

    Old Toronto, Ontario, Canada Canadian Investment Regulatory Organization Full time

    Senior Corporate Communications and Public Affairs Specialist Job Category: Professional / Technical Requisition Number: SENIO002182 Apply now Posted : May 3, 2024 Full-Time Locations Showing 1 location 40 Temperance Street Suite 2600 Toronto, ON M5H0B4, CAN DescriptionPosition Title: Senior Corporate Communications and Public Affairs...