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Associate Regulatory Manager

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Associate Regulatory Manager

 

Responsibilities:

  • Advanced ability to interpret and apply regulations and guidances. Mentor and direct others in their understanding and application of regulations and guidances.
  • Solid knowledge of Regulatory Agency organizations. Interact with Agencies during product negotiations, i.e., RB lead during meetings with Regulatory Agencies. Apply gained knowledge and experience to increasingly complex regulatory issues.  Share knowledge and experience with peers. Responsible for oversight of responses to Regulatory Agency questions.
  • Active member of trade association committees.  Effective in finding mutual short and long-term gains among diverse stakeholder interests whenever possible and incorporate them into planning and objectives with ability to influence policy development.  Develop new and sustain existing business networks, both internally and externally, as company needs arise.
  • Lead team to achieve targets, balance resources, quality and speed to market.  Set clear priorities, review project progress with ability to provide gap analysis and resolutions. Apply best practice Project Management methods, anticipating contingencies, team response and readiness in advance.
  • Oversee and consult on the development of submission strategies for projects. Responsible for submission strategy development and execution for projects in collaboration with R&D and cross-functional teams.
  • Lead team to achieve targets for integration activities and plan/manage external projects that may arise throughout the year.
  • Skilled in using available programs, RB Systems, key external agency and trade association resources to assure best in class regulatory compliance.
  • Departmental representative for RB system development projects.   Provide support/direction to others on the functionality of systems. Responsible for reviewing and approving departmental SOP/Work Practices.
  • Oversee support of a high quality and effective infrastructure to meet the regulatory requirements to support the launch and compliance of products. 

 

Qualifications:

  • BA/BS degree required in the natural or food sciences.
  • 3-5 years of relevant work experience required.
  • Experience with FDA dietary supplement products is required.
  • 3+ years of prior line management experience required.
  • Experience with FDA registered products a plus.
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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