Regulatory Affairs Associate (12 month contract)

Job description

Johnson & Johnson Inc. is a member of the Johnson & Johnson Family of Companies, the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. In Canada, Johnson & Johnson Inc. markets innovative consumer products focusing on skin and hair care, baby care, wound care, oral health and women's health as well as a broad range of well-known and trusted over-the-counter products through our McNeil Consumer Healthcare division.

At Johnson & Johnson Inc. our purpose is to "Bring Science to the Art of Healthy Living" by providing Canadians with some of the world's most widely used and trusted brands including; JOHNSON'S ® Baby, NEUTROGENA®, AVEENO® LISTERINE®, BAND-AID® Brand Adhesive Bandages, TYLENOL®, REACTINE® , BENYLIN® , NICORETTE®, NICODERM® and many more. Based in Markham, Ontario, Johnson & Johnson Inc. employs approximately 400 people and is supported by a manufacturing site and R&D facility located in Guelph, Ontario.

We are hiring a Regulatory Affairs Associate to join our team in a 12 month contract position.

Key Responsibilities:
• You will work in close collaboration with Regulatory Managers to assist in the creation, review and approval of drug product labelling to ensure compliance with Health Canada's new Plain Language Labelling (PLL) Regulations
• You will develop, maintain and approve labelling documentation as required
• You will be responsible for preparing and filing quality submissions required in support of PLL Compliance
• You will track and monitor progress of labelling updates, associated change controls and Health Canada submissions and approvals to ensure projects will meet established timelines
• You will provide timely updates to Regulatory Managers regarding project progress, in addition to timely identification, communication and resolution of issues
• Working knowledge and application of SOPs related to the job function required.

Desired profile

Qualifications :

• Ability to apply regulatory guidance and formatting requirements to generate new label manuscripts
• Ability to consolidate comments from multiple sources and ensure robust version control
• High attention to detail
• Excellent proofreading/editing skills
• Ability to multi-task, prioritize and manage multiple projects
• Good working knowledge of computer applications (e.g. MS Word, MS Excel, MS PowerPoint, MS Outlook, Adobe Acrobat)

Education and Experience:
• University degree in a scientific field (Life Sciences, Chemistry or, Pharmacy)
• Approximately 3-4 years of dynamic experience in Pharmaceutical Regulatory Affairs
• Demonstrated experience in obtaining approval of a variety of non-prescription drug submissions and in-depth knowledge of the Canadian Food & Drugs Act and Regulations and Health Canada Guidance Documents for DIN products
• Experience in corporate environment with writing and/or editing in the field of labelling/packaging desired

BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.