Regulatory Approvals Senior Manager

3 weeks ago

Saint Charles, United States Mars Full time

Job Description:

Regulatory Approvals Senior Manager (US Mars Locations considered)

Royal Canin provides Health Through Nutrition by develop and manufacture highly innovative science-based products positively impacting the health of both sick and healthy cats and dogs.  This innovative approach requires the use of novel ingredients with proven effects and regulatory approval for their use in the United States.

The Regulatory Approvals Senior Manager will develop and implement US regulatory dossier strategies for novel ingredients and products to ensure successful and timely launch in the US.  This role will work closely with the global R&D and regulatory teams to design appropriate studies and prepare regulatory submissions.  The regulatory approvals senior manager will also interact with US government officials to clarify and detail the data submitted to support regulatory submissions.  This role will collaborate across functions and with ingredient suppliers to prepare, file, and track regulatory submissions.

What are we looking for?

  • MS (or Ph.D.) or equivalent in a technical area, such as food safety or toxicology..

  • Minimum 8 years experience in Regulatory Affairs in pharmaceutical, food or feed.

  • Minimum 5 years directly supervising the regulatory approvals approval process (strategy development, study design/implementation, dossier writing, and/or responding to authorities)

  • Proven experience in writing regulatory dossiers and/or completing studies required for regulatory dossiers.

  • Ability to work independently without close supervision, meeting deadlines and demonstrating strong problem solving skills.

  • Excellent communication skills and the ability to build and leverage networks.

  • Proven ability in building cross-functional bridges to create awareness and ensure compliance is implemented.

  • Experience and knowledge with scientific studies involving cats and dogs is preferred.

  • Knowledge of AAFCO regulations and FDA laws is preferred.

What would your key responsibilities be?

  • Develop and implement the US regulatory approval strategies for key innovation projects.

  • Design regulatory studies to support novel ingredient approval and partner with R&D and ingredient suppliers to complete required studies.

  • Estimate the likelihood of regulatory success based on existing data and proposed strategies.

  • Develop regulatory risks and predictions of interactions with regulatory agencies.

  • Provide regulatory guidance on US regulatory mechanisms to optimize product development success and timelines.

  • Provide scientific expertise to ensure all US required studies meet US regulatory requirements and that the study reports accurately convey the information as needed for US regulatory submissions.

  • Prepare regulatory dossiers for submission and manage any questions from US government officials.

  • Partner with global and regional management/peers to ensure consistency in procedures and agency interactions.

  • Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Royal Canin products.

  • Strong written and verbal communication skills required to develop regulatory dossiers and communicate complex scientific data clearly and concisely.

  • Provide information, contributing to the monitoring of emerging trends and regulations in the industry through engagement in trade associations and regulatory/compliance monitoring.

  • With some supervision serve as point of contact and develop relationships with points of contact at the FDA on specific product assignment.

  • Document and communicate details and outcomes of FDA interactions to GRT and relevant Sr. management.

  • Participate in core regulatory activities to ensure effective FDA interactions consistent with the Global Regulatory strategy—including contingency regulatory planning/risk assessment.

What can you expect from Mars?

  • Work with over 130,000 diverse and talented Associates, all guided by the Five Principles.

  • Join a purpose driven company, where we’re striving to build the world we want tomorrow, today.

  • Best-in-class learning and development support from day one, including access to our in-house Mars University.

  • An industry competitive salary and benefits package, including company bonus.

#LI-BM1

Mars is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. If you need assistance or an accommodation during the application process because of a disability, it is available upon request. The company is pleased to provide such assistance, and no applicant will be penalized as a result of such a request.

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