Associate Manager Regulatory Affairs

1 week ago

Markham, Ontario, Canada Kenvue Full time

Associate Manager Regulatory Affairs W

Description


Johnson & Johnson New Planned Consumer Health Company is recruiting for an Associate Manager, Regulatory Affairs to be located in Markham, Canada.


Johnson & Johnson New Planned Consumer Health Company, based in Skillman, N.J., is one of the world's largest consumer health and personal care products company.

Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S Baby, BAND-AID, NEUTROGENA, TYLENOL, MOTRIN, and LISTERINE.

Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.


The Associate Manager, Regulatory Affairs is responsible for managing and coordinating all routine activities related to federal and provincial regulatory submissions in support of assigned JJI products fairly independently; and, to support the research and development, manufacturing, and marketing of new and existing products in a manner which ensures compliance with all appropriate government regulations and associated standards.


Key Responsibilities:

  • Work in close collaboration with the Sr. Manager and key stakeholders in the filing of quality submissions, effective problem solving and negotiations with Health Canada officials. Manage and lead approval of assigned new products and claims, manage changes to existing products and maintenance of product, with applicable government regulations and J&J standards.
  • Determine and communicate submission and compliance requirements to key stakeholders within the company and gather and compile necessary data. Provide Canadian input into Global Regulatory Affairs strategy documents to ensure local requirements are addressed.
  • Monitor and influence the Regulatory and external environment; anticipate and proactively affect changes to the Canadian Food and Drug Act and Regulations, Environmental Legislation, Health Canada Policies and Guidelines, and ICH Guidelines, as appropriate.
  • Manage initiatives and changes through participation in key industry associations, as assigned by the Sr. Manager, and/or direct interaction with regulatory authorities and professional associations.
  • Collaborate with and support JJI business partners to ensure that product claims and advertising are compliant, competitive and contribute to optimal marketing of products.
  • Review and approve product labelling/websites for accuracy and compliance to both internal and external requirements.
  • Manage submissions to/liaise with advertising preclearance agencies (i.e. Advertising Standards Canada, Pharmaceutical Advertising Advisory Board) to obtain approval for competitive consumer and professional advertising.
  • Manage competitive complaints from and to regulatory authorities and competitors, in collaboration with legal and marketing.
  • Develop and maintain scientific expertise concerning assigned therapeutic and/or functional area in order to advise the business on new opportunities, help develop new claims and be aware of (and be able to respond to) emerging competitive, regulatory and NGO threats.
  • Maintain vigilant oversight of developments within the assigned therapeutic and/or functional area, communicating key competitive learnings to key business partners, as appropriate.
  • Provide input to Global Regulatory Safety group regarding safety actions taken by Health Canada for products in your area of responsibility further to a Call for Information.
  • Support for Regulatory Operations through management of databases and submission publishing.
  • Manage oversight and activities of contractor(s), as required.

Qualifications

  • University degree in a scientific field (Life Sciences, Chemistry, Pharmacology/Toxicology or Pharmacy) is required.

Required:

  • A minimum 6 years of progressive experience in Pharmaceutical Regulatory Affairs is required.
  • Demonstrated experience in obtaining approval of submissions and knowledge of Canadian Food and Drugs Act and Regulations for noprescription products and natural health products.
  • Consumer healthcare industry regulatory experience.
  • Excellent organizational and interpersonal skills are required.
  • Strong negotiating, communication and influencing skills are required.
  • Excellent strategic and decisionmaking skills are required.
  • Strong attention to detail is required.
  • This position is to be located in Markham, Ontario, Canada and will require up to 5% domestic and/or international travel.

Preferred:

  • Expertise in chemistry, manufacturing & control and pharmacokinetics/bioequivalence submission requirement is highly desirable.
  • Experience compiling new drug submissions.
  • New drug, medical device, and cosmetic experience an asset.
  • Experience interacting with health authorities.
  • Experience interacting with relevant trade associations or serving on trade association committees.
  • Regulatory Affairs Cert

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