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US Regulatory Affairs Manager

About the Role

The  Regulatory Affairs Manager delivers innovative solutions for healthier lives and happier homes, RB is in the top 20 of companies listed on the London Stock Exchange. Today it is the global No 1or No 2 in the majority of its fast-growing categories, driven by an exceptional rate of innovation. Its Health and Hygiene Home portfolio is led by global Powerbrands of Enfamil, Nurofen, Strepsils Gaviscon, Mucinex, Durex, Scholl, Clearasil, Lysol, Dettol, Veet, Harpic, Bang, Mortein, Finish, Vanish, Calgon, Air Wick, and Woolite.   

Expected Areas of Competence
  • Provides regulatory guidance and expertise for development and review of labeling materials for U.S. marketed products.
  • Oversees technical label copy (TLC) preparation for MJ products; reviews and approves artwork and proofs for accuracy; and reviews and approves promotional materials in accordance with the LEX (labeling excellence) process and procedures.
  • Drives regulatory processes to ensure timely submissions for product/ingredient maintenance in accordance with US regulatory requirements and with business objectives.
  • Supports market requests with US submission information and documentation.
  • Stays abreast of, interprets, and communicates existing and/or proposed government regulations, registration requirements, and labeling changes to Operations, Business, and R&D disciplines and applies these changes as necessary to facilitate MJN's business plans and long-term goals.
  • Serves as a primary representative of/spokesperson for Regulatory Science on assigned project teams to ensure regulatory compliance. 
  • Establishes and maintains communication channels and constructive rapport with key partners in R&D, Supply Chain and Quality to streamline and maximize information and documentation flow.
  • Understands and communicates US FDA regulations and procedures for MJ products, especially Infant Formula, and how regulations may impact work assignments.
  • Reviews Regulatory Science standard operating procedures and work instructions for revision as needed.
  • Manages regulatory-related projects to assure MJ products are in compliance with new/revised regulations.
  • Coordinates the maintenance of accurate databases for regulatory submissions, references, internal documents, and web-based applications and shared drives for document sharing. 
  • Supports industry association activities related to US-manufactured products.
Experiences Desired
  • Demonstrated ability in preparing and maintaining dossiers such as registration submissions for regulated products.
  • Demonstrated knowledge of US labeling regulations.
  • Demonstrated ability to work with a range of technically and culturally diverse people, collaborate in team projects, and deliver value-added business results that meet high quality requirements within tight deadlines.
  • Experience in working with RB/MJ databases.
  • Experience in dealing with issues pertaining to the launch and support of new products.
Knowledge Desired
  • Combination of training in scientific disciplines, such as Nutrition, Food Science, Chemistry, Pharmacy or Biochemistry and experience in food regulation-related field preferred.
  • Basic understanding of the regulatory and registration requirements for U.S.-manufactured products.
  • Familiarity of the necessary requirements and time constraints for registration, labeling and advertising of MJ products.
  • Working knowledge of MJ computer systems and databases.
Developmental Value
  • Broader understanding of RB/MJ Global Business Operations, and regulatory and registration requirements affecting our products.
  • Opportunity to build a network with North America and Global MJ professionals.
  • Deepen understanding of registration requirements for different products.
  • Deepen understanding of US FDA infant formula regulations.
  • Develop the ability to, through effective communication, impact and influence people/areas within the company to deliver superior business results.
  • Understand implications of personal accountability in speed to bring new packaging, processing or minor reformulated products to the market, as registration outcomes are influenced and as they influence MJ process.
  • Opportunity to enhance teamwork, project leadership, focus on client and informational systems skills.
  • Increase opportunities to address consumer needs as well as consumer desires.
  • Develop understanding of varying nutritional needs of infants and children.

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.

Nearest Major Market: New York City
Nearest Secondary Market: Newark

Job Segment: Pharmacy, Nutrition, Healthcare

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