Johnson & Johnson Careers
Regulatory Affairs Co-op (Sept 2018, 8 months or 12 months)
Requisition ID: 8430180104
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, we market innovative consumer products focusing on skin and hair care, baby care, wound care, and oral health, as well as a broad range of well-known and trusted over-the-counter products through our McNeil Consumer Healthcare division.
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, we employ approximately 400 people and are supported by a manufacturing site and R&D facility located in Guelph, Ontario
We are looking for a Regulatory Affairs Co-op to join our team on an 8 or 12-month (preferred) work term.
Key Role Responsibilities:
• Prepares submissions (e.g., NHP PLAs, DIN submissions, SNDSs, NCs, Level III notifications, Class II medical device applications/amendments, cosmetic notifications forms)
• Prepares responses to regulatory body queries
• Files various annual renewal packages to Health Canada
• Performs assessments to determine regulatory requirements for new projects
• Reviews and approves packaging artworks and/or advertising materials
• Completes environmental ingredient surveys under CEPA
• Assists in audit preparation and provision of documents to auditors
• Responds to requests for regulatory information from our safety organization to support preparation of aggregate safety reports (e.g., PBRERs)
• Monitors departmental mailbox/fax and triages Health Canada and other correspondence
• Monitors and tracks communications and commitments to Health Canada
• Maintains various regulatory databases/trackers
• Enrolled in a post-graduate Regulatory Affairs certification program, available to work an 8 or 12 month (preferred) work term. Please indicate your availability in your resume or cover letter.
• Undergraduate science degree preferred
• Excellent communication (written and verbal) and strong interpersonal skills
• Good problem-solving and analytical skills
• Self-driven, ability to work independently
• Results-driven, excellent attention to detail
• Strong project management skills and ability to manage multiple priorities
• Strong office software skills
We offer a work culture that is open, innovative, and performance driven with an environment that is fun and sophisticated. We have an onsite fitness facility and an online company store exclusive to employees, where you can purchase J&J products. We also offer opportunities for employees to get involved in sports team, social events and volunteering with local charities.
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.
Johnson & Johnson Inc. (7695)