Regulatory Affairs Project Lead

Johnson & Johnson Consumer Inc. is recruiting for a Regulatory Affairs Project Lead (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 provide management and leadership to plan, prepare, and execute high quality projects for Canada for OTC drug, natural health product, cosmetic and medical device products. You will interface with internal departments and company leadership, and externally with Health Canada, sponsors, and vendors. Your scope includes the development of regulatory strategies and submissions for filing to Health Canada and other regulatory responsibilities as required. You will help drive the success of the integration and creation of a stand-alone Consumer Health business in Canada! Key Responsibilities: Act as Regulatory Affairs (RA) Lead to develop the regulatory plan and activities for the creation of a stand-alone Consumer Health company by representing RA at cross functional meetings and collaborating with key business partners and Health Canada and being the voice for RA. Lead the implementation of regulatory activities associated with the development of a stand-alone Consumer Health company by ensuring regulatory compliance with Health Canada regulations and alignment with company objectives. Lead all aspects of and obtain timely Health Canada approvals for products, product license / filings and GMP site license updates, through development of effective regulatory strategies, filing of quality submissions, effective problem solving and discussions with Health Canada officials. Lead projects and develop, review, and approve artwork and promotional copy to ensure regulatory compliance to internal and external requirements. Leverage resources, expertise, and knowledge across multiple projects to ensure attainment of project objectives within specified timelines. Collaborate and influence decisions in a highly matrixed organization, as well as in cross-functional team settings. Lead regulatory initiatives and change through participation in key industry associations, and/or direct interaction with regulatory authorities and professional associations. Develop and improve systems, processes, tools to enhance effectiveness and efficiencies of the RA department May lead a small number of contractors or consultants. Qualifications Education and Experience Education: University degree in a scientific field (Life Sciences, Chemistry, Pharmacology/Toxicology or Pharmacy). Required: Minimum 6+ years of experience in non-prescription pharmaceutical/NHP/cosmetic regulatory affairs. Demonstrated experience in acquiring approval of submissions and knowledge of the Canadian Food & Drugs Act and Regulations and Health Canada Policies and Guidelines. Canadian non-prescription drug, device, natural health product and cosmetic experience. Consumer healthcare industry regulatory experience. Excellent organizational, interpersonal, communication and decision-making skills. Excellent influencing skills and ability to work in an environment with ambiguity and change. Excellent strategic and negotiating skills. Strong attention to detail. Strong working knowledge of computer applications. Preferred: Expertise in chemistry, manufacturing & control, and pharmacokinetics/bioequivalence submission requirement People management experience an asset. 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 2206047583W