Senior Regulatory Affairs Associate (1 of 2)

Job title:

Senior Regulatory Affairs Associate (1 of 2)

Company

Johnson & Johnson

Job description

Description

Kenvue is currently recruiting for a Senior Regulatory Affairs Associate. This position reports into Director Regulatory Affairs and is based at Markham, ON Canada.

Who We Are

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands – including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future-and yours.

Based in Markham, Ontario, Kenvue employs approximately 400 people and is supported by one manufacturing and R&D facility located in Guelph, Ontario.

The Senior Regulatory Affairs Associate is responsible for managing and coordinating all routine activities related to federal and provincial regulatory submissions in support of assigned Kenvue products under supervision; supporting 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. You will interface with key stakeholders to plan and execute the pre- and post-integration regulatory activities involved in the creation of a stand-alone Consumer Health business in Canada!

What You Will Do

In this role, you will

• Work in close collaboration with your senior Regulatory Affairs (RA) personnel 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.
• Determine and communicate submission and compliance requirements to key stakeholders within the company and gather and compile necessary data.
• Monitor and influence the regulatory and external environment; anticipate and proactively affect changes to the Canadian Food and Drug Act and Regulations, Policies/Guidelines, Cosmetic Regulations, Drug Regulations, Natural Health Product Regulations, and Medical Device Regulations.
• Maintain compliance within the department by ensuring global, regional, and local processes, policies, SOPs and working instructions are adhered to.
• Collaborate with and support Kenvue 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 senior RA personnel, 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
• Maintain vigilant oversight of developments within the assigned therapeutic and/or functional area, communicating key competitive learnings to Marketing and RA colleagues as appropriate.
• Keep abreast of all product changes and other issues relating to the sale and distribution of marketed products through Change Control processes and regular communication with colleagues (i.e. Marketing, Medical Affairs, CMC RA, R&D, QA/QC, Global Regulatory). Ensuring all the marketed products retain positive registration status in the changing regulatory environment and are in compliance with Canadian Food and Drug Act and Regulations and other applicable legislation (e.g. Environmental Regulations).
• Provide scientific assessment of new business opportunities (in consultation with senior RA personnel as appropriate), to enable Marketing to make educated decisions.

Qualifications

What We Are Looking For

Required Qualifications:

• A minimum University degree in a scientific field (Life Sciences, Chemistry or, Pharmacy, etc.).
• Minimum 4 years of experience in Consumer/Pharmaceutical Regulatory Affairs or relevant field.
• Demonstrated experience in obtaining approval of regulatory submissions is required.
• General knowledge of the Canadian Food & Drugs Act and Regulations and Health Canada guidelines and policies.
• Very good organizational, communication, and interpersonal skills.
• Good strategic and decision-making skills.
• Strong working knowledge of computer applications (e.g. MS Word, MS Excel, MS PowerPoint, MS Outlook, Adobe Acrobat).
• This position is to be located in Markham, ON and will require up to 5% travel domestic or internationally.

Desired Qualifications:

• Canadian non-prescription drug, medical device, natural health products, and cosmetics experience.
• Experience negotiating and interacting with health authorities.
• Experience interacting with relevant trade associations or serving on trade association committees.
• Regulatory Affairs Certification (RAC).
• e-CTD submission and database management experience.

What’s In It For You

• Competitive Benefit Package

• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

• Learning & Development Opportunities

• Employee Resource Groups

• This list could vary based on location/region

BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within Kenvue.

Kenvue is proud to be an 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.

#LI-AK2

Expected salary

Location

Markham, ON

Job date

Mon, 15 Jan 2024 23:43:17 GMT

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