Regulatory Operations Specialist (Remote)

Position Summary

The Regulatory Operations Specialist is to follow the Regulatory Submission Plan shared by the International Business or the project team. The Regulatory Operations Specialist will work with Market RSA, third-party distributor, and the Global Holistic Health team to align on document preparation timelines according to the given projects and markets. The Regulatory Operations Specialist will contact the relevant stakeholders (factories, R&D, MRM, and other Global Holistic Health teams as required) for the compilation of registration documents (dossier) required for all types of Regulatory Submissions for license applications. The Regulatory Operations Specialist will use the POLARIS registration system to prepare the regulatory requirements spreadsheet, templates for the registration documents, and compilation of the registration dossiers for assigned product categories and markets. The Regulatory Operations Specialist will use the management of change (MOC) tool for the management of change controls. All the ad-hoc support to be provided to the Global Regulatory Operations and Holistic Health Global Regulatory Team as assigned (including unplanned activities).

Key Responsibilities

• Regulatory Registration Requirements: Compilation and maintenance of Regulatory Registration Requirements for assigned markets and product categories.
• Dossier Compilation for registration submission: Liaise with Holistic Health factories, Global RSA, co-mans, and third-party distributors for the collection and distribution of documents required for registrations (new, renewals, post-submissions). Perform a final review of the documents received from the factory and Global teams as per market requirements prior to dispatch to markets/distributors (Right First Time).
• Polaris (Regulatory Registration System): Project manage all submissions via Polaris (Regulatory Registration System), and maintain the Registration Requirements Spreadsheet up to date. Maintain license database and follow up on license renewals.
• Support markets and the global regulatory team to draft Registration document templates and to harmonize them.
• Provide support to the new RSA/distributor on the training of the system.
• Management of Change: Management of Change Controls (MOC)- Help raise the Global MOCs and Factory change controls by using the MOC tool. Help complete the required market assessment via the MOC tool. Support market RSA on the Change in Regulation communication via MOC Tool (Reverse MOC). Support on collection of required documents for markets/distributors to update registration/notification related to change controls.
• Import/Export: Support supply chain team with regulatory documents required to import/export documents out of US factories.

Experience and Education Requirements

• Minimum degree level qualification in Food Science or related Food Discipline or Pharmaceutical / Science related degree.
• Work experience in the Food, Supplement or Pharma industry.
• 5+ years of experience in regulatory affairs or in Quality or R&D in the Food industry or the Pharma industry.
• Any Knowledge of Food / Pharma Registration and submission process is a plus.
• Any Project Management experience, demonstrating the ability to successfully lead a project (worked on a project with a team).
• Any regulatory or document management system usage experience is a plus.
• Fully fluent in English, and other languages are a plus.

Pay Range

The approximate pay range for this position is $70,000.00 to $85,000.00. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities as well as geographic location.

About Us

Nestlé Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life®, Nature's Bounty®, Vital Proteins®, Orgain®, Nuun®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more. We also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases. At Nestlé Health Science, we bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. We are committed to fostering professional growth and celebrating the achievements of our people along the way. We offer dynamic career paths, robust development, opportunities to learn from talented colleagues around the globe, and benefits that support physical, financial, and emotional wellbeing. Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers.