Regulatory Affairs Manager

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Johnson & Johnson Consumer Health is looking for a Regulatory Affairs Manager, Norway based in Oslo (Norway) or Stockholm (Sweden). Company Background & Culture At Johnson & Johnson Consumer Health, we are driven to improve the personal health of people everywhere. We deliver products that are rooted in science and endorsed by professionals. Our differentiated portfolio of iconic brands delivers life-enhancing, first-to-market innovation. By combining the power of science with meaningful human insights and digital-first thinking, we help more than 1.2 billion people live healthier lives every day, from their very first day. At Johnson & Johnson Consumer Health, we take a total health approach to helping people live their healthiest lives. To thrive, people need healthy places to live, work, and play. We’ve set ambitious goals to deliver greater benefits for people, communities, and our planet. We will provide full transparency on ingredients because consumers should be able to easily make informed choices. We’re deepening partnerships to tackle complex health issues, starting with smoking cessation and preventable skin cancers because healthy lives require going all in to reduce preventable diseases. And, we are innovating to make our packaging easier to recycle or reuse, increasing our use of recycled plastics and paper in our packaging, and powering more of our operations with renewable energy because healthy lives demand a healthy planet. Our Healthy Lives Mission will invest $800 million through 2030 to advance initiatives both inside and outside of our Company. When you choose our brands, you choose a healthier today and a healthier tomorrow. Role Purpose: Johnson & Johnson Consumer Health is currently recruiting a dedicated Regulatory Affairs Manager, Norway to lead its exciting and iconic range of Consumer Health brands. The successful candidate will act as the local regulatory expert on designated products. The jobholder plays a key role in the cross-functional country team and is part of a strong Northern Europe Regulatory Affairs team reporting directly to the Director of Regulatory Affairs, Northern Europe. Key responsibilities include: Overall responsible for a portfolio of Consumer Health products in the Norwegian market. Maintaining and seeking new marketing authorization through the national and European Procedures (Mutual Recognition and Decentralized Procedures). Responsibility for review and approval of advertising materials for OTC medicines consistent with local requirements Handling a range of Cosmetic preparations in Norway and the Nordics Develop, lead, and support regulatory strategy in line with company business strategy Portfolio responsibility for full life cycle management including local responsibilities to define and implement submission strategy for existing marketing authorization e.g., Company Core Data Sheets, aggregate reports, Module 3 changes, Product Information (SmPC, PIL, Label) Monitoring local regulatory intelligence for the Consumer Health portfolio responsibilities Provide expert knowledge of the local regulatory authority (NOMA) Strong collaboration with the local commercial team and regional regulatory team to seek, shape and implement business plans and regulatory strategy. Ensure efficient compliance to external local, and regional legislation and internal compliance obligations and requirements Represent local regulatory affairs in audits and inspections Qualifications Qualifications: Pharmaceutical or scientific university degree Significant experience in Regulatory Affairs working directly with NOMA within the pharmaceutical/ Consumer Healthcare industry Preference for OTC Regulatory Affairs experience and desirable to have a working knowledge of Cosmetic Regulatory Affairs Proven knowledge and track record of working with Advertising regulations for OTC medicines Thrives working in working cross-functional setting at a local/regional level and must enjoy working with the small local team in a commercial setting to come up with science-driven solutions to serve our Customers and Consumers. A self-starter that enjoys empowerment, is solution-focused, operates in a cross-functional environment, using project management skills to achieve deliverables Advanced Proficiency in Norwegian and English We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation. 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 Norway-Oslo-Oslo- Organization Janssen Cilag Norway (7314) Job Function Regulatory Affairs Requisition ID 2206053024W