Johnson & Johnson Consumer Health (JJCH) is currently recruiting an Associate Manager, Regulatory Affairs, Skin Health/Beauty located in Skillman, NJ!
The Associate Manager works closely with cross-functional partners across various functions including but not limited to, R&D, Commercial, Legal, Quality, Medical, Clinical Sciences. The Associate Manager will support new product innovation through base business implementation, and post-marketing and compliance related activities.
At Johnson & Johnson Consumer Health, we’re here to change the world. We are a diverse group of leaders who think digital-first and push boundaries as much as we push ourselves. And, for other like-minded leaders out there looking to make their mark, we’ve got three words for you: change happens here.
We combine meaningful human insights and digital-first thinking to help people take better care of themselves and their loved ones. We believe in the power of new perspectives and insights to drive innovation. Our culture is diverse and inclusive – a place where individually dynamic but collectively brilliant results in smarter solutions for all the communities we serve.
We are industry leaders, earning the #1 or #2 position in most of the categories in which we compete. Our iconic and beloved brand, including TYLENOL®, ZARBEE’S NATURALS®, NEUTROGENA®, AVEENO®, LISTERINE®, OGX® and JOHNSON’S®, are rooted in science and endorsed by professionals, helping more than 1.2 billion people live healthier lives every day, from their first day.
On November 12, 2021, 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 employee representative bodies, as required, and other customary conditions, and approvals. It is anticipated that, following conclusion of the transaction, you will be an employee of an entity within the newly created Consumer Health company and your employment will be governed by that company’s employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you at an appropriate time and subject to any necessary consultation processes.
This position will report to the Associate Director, Regulatory Affairs. Products within the scope of responsibility include a wide range of Regulatory classifications; Cosmetics, Drugs (e.g., OTC Monographs / NDA / ANDA / Rx-to-OTC Switch), Medical Devices and Combination products.
- Has responsibility for a large portfolio of products, supporting a significant area of the business. Represents Regulatory Affairs on cross-functional product/project teams and provides regulatory advice. Communicates information and presents status updates on product/project activities to key internal/external stakeholders.
- Manages small work groups and provides direction.
- Applies organizational understanding and awareness and participates in decision making in collaboration with others.
- Uses effective communication and employs influencing skills to establish key relationships with internal/external contacts.
- Works independently to plan, conduct, and mange regulatory activities to meet department and company objectives.
- Develops, translates (if relevant), reviews and approves artwork and promotional copy material to ensure regulatory compliance.
- Prepares and compiles regulatory submissions, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines for internal review / approval.
- Uses available electronic publishing tools to compile, electronic or paper-based submissions necessary to meet regulatory requirements.
- Develops timelines for submissions and monitors progress of applications against set timelines, acting where necessary to minimize delays and anticipate difficulties.
- Provides input to regulatory strategies.
- Interacts with regulatory agency personnel to expedite approval of pending applications and to resolve regulatory matters. Agencies include but are not limited to FDA, USDA, US Customs and Border Protection, etc.
- May represent J&J and provides regulatory advice at e.g., joint company/trade association initiatives, regulatory agency meetings etc. (as appropriate).
- Minimum B.S. Chemistry, Pharmacy, or related scientific field
- 4+ years of industry related experience
- Working knowledge of regulatory requirements for various regulatory classifications (i.e., cosmetic, monograph drugs and medical devices)
- Knowledgeable of the competitive landscape
- Technical/science-based background
- Basic knowledge of GMP and regulatory compliance
- Good interpersonal and written skills
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 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.
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.
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.]