Johnson & Johnson Careers

Regulatory Affairs Intern (Summer 2018, 12 months)

Markham, Canada
Administration


Job Description

Requisition ID: 8429180104

Johnson & Johnson Inc. is a member of the Johnson & Johnson Family of Companies, the world’s most comprehensive and broadly based manufacturer of healthcare products, as well as a provider of related services for the consumer, pharmaceutical, and medical devices and diagnostics markets.

With headquarters in Markham, Ontario, Johnson & Johnson Inc. is a leader in the consumer healthcare market. We market leading brands in over-the-counter pain relief, allergy relief, baby, skin, hair, oral, wound and many other health, beauty and personal care categories. We offer a work culture that is open, innovative, and performance driven with an environment that is fun and sophisticated. Within our facilities, we have a fitness centre that you can access. We have 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 to volunteer with local charities.

We are looking for a Regulatory Affairs Intern to join our team on a 12 month work term, based in Markham, Ontario.

Key Role Responsibilities:

Regulatory Submission Support:
• Provides assistance to Regulatory Managers in the preparation of submissions to Regulatory bodies and to assist in the preparation of responses to queries to achieve product approval.
• Monitors and tracks communications and commitments to Health Canada (e.g. responses to Clarifaxes and Information Request Notices.)

Regulatory Departmental Coordination:
• Administers the Annual Drug Notification Process
• Coordinate and respond to Call for Information (CFI) requests in support of annual safety reporting and track responses.
• Gathering and provision of metrics (e.g. Company Core Data Sheet status, Health Authority request status)
• Monitors the RA mailbox and triages requests from Health Canada and the Safety Organization to the appropriate RA Manager
• Responsible for updating databases such as the Regulatory Database, and 
CONNECT.
• Prepares/updates routine reports for the Managers (i.e., monthly regulatory affairs report, product lists, etc.)
• Support regulatory activities relating to different projects and other duties as assigned.
• Assists in audit preparation and provision of documents to auditors

Controlled Documents:
• Creation and revision of SOPs regarding Regulatory processes.

Environmental Activities:

• Complete environmental / ingredient surveys under CEPA


Qualifications
• Currently enrolled in a post-graduate Regulatory Affairs or related certificate program, available to work for up to 12 months beginning in Summer 2018.
• Completed undergraduate degree in biological sciences, pharmacy or related discipline is required.
• Strong software and technical skills to be able to work with regulatory databases.
• Excellent communication (written and verbal) and strong interpersonal skills.
• Results-driven; excellent attention to detail.
• Good problem-solving and analytical skills.
• Strong project management skills; able to manage multiple priorities.
• Ability to work independently.


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.


Primary Location
Canada-Ontario-Markham
Organization
Johnson & Johnson Inc. (7695)
Job Function
Administration
Requisition ID
8429180104