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Regulatory Affairs

Regulatory Affairs Specialist

  • Titel Regulatory Affairs Specialist
  • Functie Regulatory Affairs
  • Sub functie Regulatory Affairs
  • Locatie Skillman, New Jersey, United States
  • Gepost
  • Referentie 2206090737W
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Beschrijving

Johnson & Johnson is recruiting for a Specialist 2, Regulatory Affairs, located in Skillman, NJ!

Johnson & Johnson Consumer Group of Companies develops and markets consumer healthcare, baby care, and beauty/skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON'S® Baby, leading skin care brands such as NEUTROGENA®, AVEENO®, CLEAN & CLEAR®, LUBRIDERM® and healthcare products such as ROGAINE®.

Do you strive to join an outstanding team that is dynamic? Apply to this opportunity today!

The individual will have responsibility for performing regulatory functions to support the launch of NeoStrata and Exuviance products and support other Skin Health brands. In addition to working with the internal departments, they will collaborate closely between NeoStrata and Johnson & Johnson to ensure processes and strategic alignments are mantained. They will be the NeoStrata regulatory point of contact for J&J cross functional teams like Medical Safety, Toxicology, Raw material teams, etc. They will develop technical expertise in global regulatory cosmetic compliance activities, understand and be current on the various US & international regulations. Excellent communication/organizational skills, knowledge of cosmetic/OTC regulatory documentation requirements and meticulous attention to detail are must have prerequisites.

Key Responsibilities:

Responsibilities

  • Works with supervision to plan, conduct, and manage regulatory activities to meet department and company objectives.
  • Sophisticated knowledge of current regulations for assigned area of responsibility with sufficient experience and skill to implement under general supervision.
  • Ensures compliance within the department by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.
  • Ensures compliance with regulatory agency requirements and interpretations. Monitor regulatory environment for changes to requirements.
  • Updates relevant global, regional and local databases to ensure 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.
  • May assist in promotional material reviews including digital media as well as labeling review and 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, taking action where necessary to minimize delays and anticipate difficulties.
  • Collaborates with internal and external business partners such as medical affairs, clinical research, marketing, and legal on various projects.
  • Assists in evaluating ingredients and formulas as well in compiling annual reports and participating in Label Working Groups as required.
  • Supports product registration and submissions processes.
  • Assists in resolving regulatory issues which could impact products on the market.
  • Assesses new guidance documents, competitive activity and provides insights and impact assessments to the business
  • Uses available electronic publishing tools to compile electronic or paper-based submissions necessary to meet regulatory requirements.
  • Communicates information and presents status updates on product/project activities to key internal/external collaborators.
  • May interact with regulatory agency personnel in order 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.
  • Maintains and archives all regulatory documentation (as appropriate).
  • Organizes and maintains reporting schedules
  • Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
  • Provides input to regulatory strategies.

Kwalificaties

Education:

  • Minimum B.S. Chemistry, Pharmacy or related scientific field

Experience and Skills:

Required:

  • A minimum of 5 years of related industry experience.
  • Working knowledge of regulatory requirements for cosmetics, OTC monograph drugs, and medical devices
  • Technical/science-based background
  • Good interpersonal and written skills

Preferred:

  • Basic knowledge of GMP and regulatory compliance
  • Working knowledge of EU Cosmetic regulations
  • Experience working with multi-functional teams
  • Experience working with global teams

Other:

  • Available for regional travel up to 10%.

FOR US/PR ONLY :

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.]

For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $72,000 to $101,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

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