Job Information
J&J Family of Companies Regulatory Affairs Specialist-12 month contract in Markham, Ontario
Regulatory Affairs Specialist-12 month contract - 2407026331W
Description
Kenvue is currently recruiting for:
Regulatory Affairs Specialist-12 month contract
This position reports to the Associate Director Regulatory Affairs and is based in Markham, Canada
Who we are
At Kenvue (http://kenvue.com/careers) , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnsons and BAND-AID Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the 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 futureand yours. For more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX_M) .
Role reports to: Associate Director Regulatory Affairs
Location: Markham, Canada
Travel %: none
What you will do
In this role, you will manage and coordinate all routine activities related to federal and provincial regulatory submissions in support of Kenvue products under close supervision. You will support the research, 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 regulatory activities for Kenvue products.
Key Responsibilities:
Act as Regulatory Affairs (RA) contact to plan, conduct and manage regulatory activities for Kenvue by completing surveys, providing regulatory impact summaries, and communicating regulatory requirements and solutions to cross functional partners.
Prepare and file submissions for new and existing products, product license / filings and GMP site license updates, through development of effective regulatory plans and problem solving.
Review and approve artwork and promotional copy to ensure regulatory compliance to internal and external requirements.
Work as part of a team and take responsibility for assigned tasks and/or projects. Have working knowledge of regulations and guidance relevant to non-prescription drugs, NHPs, medical devices and cosmetic products.
Under guidance, interact with regulatory agency personnel to seek guidance, expedite approval of pending applications and to resolve regulatory matters.
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 key partners.
Maintain compliance within the department by ensuring global, regional, and local processes, policies, SOPs and working instructions are adhered to.
Update relevant global, regional, and local databases to ensure compliance with internal requirements
Qualifications
What we are looking for
Required Qualifications
University degree in a scientific field (Life Sciences, Chemistry, Pharmacology/Toxicology or Pharmacy).
0-2 years of experience in consumer health regulatory affairs (non-prescription pharmaceuticals/NHPs/medical devices/cosmetics).
Knowledge of Canadian non-prescription drug/medical device/natural health product/cosmetic regulations.
Competency Requirements:
Good organizational, interpersonal, communication and decision-making skills.
Ability to work in an environment with ambiguity and change.
Good strategic and negotiating skills.
Strong attention to detail.
Strong working knowledge of computer applications.
Regulatory Affairs Certification (RAC) preferred.
Desired Qualifications
Experience in chemistry, manufacturing & control, and pharmacokinetics/bioequivalence submission requirements.
Experience in acquiring approval of submissions and knowledge of the Canadian Food & Drugs Act and Regulations and Health Canada Policies and Guidelines.
Experience interacting with health authorities.
Experience interacting with relevant trade associations or serving on trade association committees.
Whats in it for you
Competitive Total Rewards Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Employee Resource Groups
This list could vary based on location/region
Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.
Primary Location NA-CA-Ontario-Markham
Travel No
Job Function Regulatory Affairs
Req ID: 2407026331W