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Regulatory Associate Manager

Description

RB is the world’s leading consumer health and hygiene company. We work with the best people to challenge conventional thinking and keep giving people innovative solutions for healthier lives and happier homes, through our brands.

A fantastic opportunity is available for a Regulatory Associate Manager to join our team in Parsippany, NJ. 

 

  • The Regulatory Associate Manger has the ability to work autonomously to oversee day-to-day Regulatory Affairs activities for specific area(s) of responsibility.
  • Manages compliance within the department by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.
  • Manages updates to relevant local databases to ensure compliance.
  • Plans, conducts and manages the coordination and compilation of regulatory submissions, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines.
  • Develops, translates, reviews (if relevant) and approves artwork and promotional copy to ensure regulatory compliance for submissions.
  • Interacts with regulatory agency personnel in-order to seek guidance, expedite approval of pending applications and to resolve regulatory matters.
  • Supports functional activities to ensure both short and long-term department and company objectives are met.
  • Understands the regulatory landscape across an assigned area of business. Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company’s areas of interest.
  • Provides risk assessments balancing business needs and risks to be challenged by Non- Government Organizations (NGOs), authorities or competitors.
  • Provides assessments and data to execute plans to address sensitive, competitive and PR  type issues.
  • Uses available electronic publishing tools to compile electronic submissions necessary to meet regulatory requirements.
  • Monitors progress of applications of self/direct reports against set timelines, taking action where necessary to minimize delays and anticipate difficulties.
  • Provides executive summaries and status updates on product/project activities to key internal/external stakeholders.
  • Contributes to the development regulatory strategies and identifies gaps that may impact implementation within their area of responsibility.
  • May represent RB Health and provide regulatory advice at e.g. joint company/trade association initiatives, regulatory agency meetings etc. (as appropriate).
  • Oversees or initiates development of best practices for Regulatory Affairs processes.
  • Provides technical guidance and solutions to complex problems in which data analysis requires an evaluation of intangible variables.
  • Maintains and archives regulatory documentation (as appropriate).
  • Ensures quality and compliance in all actions.
Requirements
  1. Represents Regulatory Affairs on cross-functional product/project teams and provides regulatory advice.
  2. May Manage small work groups and/or provides direction.
  3. Applies organizational understanding and awareness and participates in decision malting in collaboration with others.
  4. Uses effective communication and employs influencing skiIls to establish key relationships with internal/external contacts.
  5. Shares knowledge and learning’s with wider regulatory team.
  6. Supports Manager with recruitment of high caliber professionals and/or contractors.
  7. Typically requires 3+ years of relevant experience with BSc or equivalent.
  8. Experience with US Regulations and FDA essential.
Equality

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.

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