HireDiversity

Markham, ON, CA

Regulatory Affairs Associate Manager - Johnson & Johnson Inc. - Markham, ON-2608130128

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 most 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 two manufacturing sites and two R&D facilities located in Guelph, Ontario and Montreal, Quebec.

The Regulatory Affairs Associate Manager is responsible for managing and coordinating all routine activities related to federal and provincial regulatory submissions in support of assigned Johnson & Johnson products fairly independently; 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.

Major Responsibilities

Work in close collaboration with the Director; Regulatory Affairs 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, manufacturing site and establishment licenses in compliance 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.

Monitor and influence Regulatory and External Environment; anticipate and proactively affect changes to the Canadian Food and Drug Act and Regulations, Medical Device Regulations, Environmental Legislation, TPD Policies/Guidelines, Cosmetic Regulations, and ICH Guidelines.

Manage initiatives and changes through participation in key industry associations, as assigned by the Director, and/or direct interaction with regulatory authorities and professional associations (i.e. Canadian Dental Association, Canadian Pharmacists Association, CHPC, and CCTFA).

Collaborate with and support JJI business partners to ensure that product claims and advertising are compliant, competitive and contribute to optimal marketing of products.

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

Maintaining vigilant oversight of developments within the assigned therapeutic and/or functional area, communicating key competitive learnings to Marketing/New Business Development and Regulatory Affairs colleagues as appropriate.

Qualifications


Education and Experience Requirements:

University degree in a scientific field (Life Sciences, Chemistry or, Pharmacy) required.

Minimum 6 years of progressive experience in Pharmaceutical Regulatory Affairs Demonstrated experience in obtaining approval of complex submissions and in-depth knowledge of the Canadian Food & Drugs Act and Regulations, Medical Device Regulations, Cosmetic Regulations and HC guidelines and policies.

Expertise in Chemistry, Manufacturing & Control and Pharmacokinetics / Bioequivalence submission requirement is highly desirable.

Canadian non-prescription drug, device, Natural Health Products and cosmetic experience an asset.

Competency Requirements:

Excellent organizational and interpersonal skills

Strong negotiating, communication and influencing skills

Excellent strategic and decision-making skills

Strong working knowledge of computer applications

English-French bilingualism an asset

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:North America-Canada-Ontario-Markham
Organization: Johnson & Johnson Inc. (7695)
Job Function: Regulatory Affairs