Johnson & Johnson Inc. is recruiting for a Regulatory Affairs Associate for a 10-month contract to work on a labelling project, located in Markham, Ontario.
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products.
The Regulatory Affairs Associate 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.
- Develop, maintain and approve labelling documentation.
- Track and monitor progress of labelling updates, associated change controls and Health Canada submissions and approvals to ensure projects will meet established timelines.
- Provide timely updates to regulatory and project teams 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.
- Creation and ownership of labeling change controls.
- Other Regulatory Affairs activities as the need arises.
- University degree in a scientific field (Life Sciences, Chemistry or, Pharmacy) is required
- A minimum of 1 year of experience in Pharmaceutical Regulatory Affairs (or a Post Graduate Regulatory Affairs Certification) is required
- Knowledge of the Canadian Food & Drugs Act and Regulations and Health Canada Guidance Documents for DIN products is required
- Experience in corporate environment with writing and/or editing in the field of labelling/packaging desired
- Ability to apply regulatory guidance and formatting requirements to generate new label manuscripts and mark up existing labels is preferred
- Ability to consolidate comments from multiple sources and ensure robust version control is preferred
- Excellent proofreading/editing skills is required
- Ability to multi-task, prioritize and manage multiple projects with short deadlines is required
- Strong working knowledge of computer applications (e.g. MS Word, MS Excel, MS PowerPoint, MS Outlook, Adobe Acrobat) is required
- This role will be located in Markham, Ontario and will required 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.
Johnson & Johnson Inc. (7695)