Regulatory Affairs Associate

Johnson & Johnson Inc. (JJI) is recruiting for a Regulatory Affairs Associate (2-year contract) role in Markham, ON Canada. Johnson & Johnson Consumer Inc. is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, AVEENO®, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, BENYLIN® and LISTERINE®. Each one of our consumer businesses adopts innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives. We are blending our heart, science, and ingenuity to profoundly change the trajectory of health for humanity. At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have striven to keep people well at every age and every stage of life. Johnson & Johnson is the world’s largest and most broadly-based health care company, committed to using our reach and size for good. We strive to improve access and affordability, build healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. Learn more at www.jnj.com. Follow us at @JNJNews. In this role, you will manage and coordinate all routine activities related to federal and provincial regulatory submissions in support of JJI 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 the pre and post-integration regulatory activities involved in the creation of a stand-alone Consumer Health business in Canada! Key Responsibilities: Act as Regulatory Affairs (RA) contact to plan, conduct and manage regulatory activities for the creation of a stand-alone Consumer Health Company 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 Education and Experience: Education: University degree in a scientific field (Life Sciences, Chemistry, Pharmacology/Toxicology or Pharmacy). Required: Minimum 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. 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 Preferred: Experience in chemistry, manufacturing & control, and pharmacokinetics/bioequivalence submission requirement. 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. Regulatory Affairs Certification (RAC). Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions, and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health and your employment would be governed by New Consumer Health’s employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of full COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com. Johnson & Johnson is an Affirmative Action and 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. Primary Location Canada-Ontario-Markham-88 McNabb Street Organization Johnson & Johnson Inc. (7695) Job Function Regulatory Affairs Requisition ID 2206047490W