Manager Regulatory & Scientific Affairs (Remote) at Nestle in Bridgewater, NJ
Nestle Health Science invests in every employee to make certain each person can reach their greatest potential and works in an environment rooted in respect, diversity and teamwork. We focus on empowering the patients and consumers we serve to live healthier lives through industry leading nutrition and nutrition-enabling solutions by keeping their needs at the center of everything we do. We make quality and innovation our highest priorities when delivering our trusted brands such as BOOST , Carnation Breakfast Essential , Peptamen , Compleat Organic Blends , Zenpep , and many more. We are a globally recognized leader in the field of nutrition science with our US headquarters in Bridgewater, NJ, and have over 5000 employees around the world. Come join the Nestle Health Science family and experience exciting opportunities! Position Summary An exciting opportunity you don't want to miss! As the Vitaflo North America (NAM) Regulatory Manager you will be responsible for the operational implementation of regulatory compliance for the Vitaflo product portfolio in the US and Canada, to include the innovation pipeline, labeling compliance and approval of all product communication. Prepare and/or submit product dossiers for registration or reimbursement. Provide support for the Medical Affairs and Marketing teams. Key
Responsibilities:
o Determine the local requirements for registration documentation and the regulatory processes. Develop internal and external relationships and build knowledge of the regulatory environment within the US and Canadian territories. o Implementation of the Nestle compliance requirements for legacy and new products within the innovation pipeline for the US and Canada in collaboration with the Vitaflo Global Regulatory and R&D teams. o Implementation of regulatory and internal NHSc requirements to ensure compliance of all marketing materials shared externally, including:
- Printed; brochures, sales aids, recipe books, etc - Digital; Closed-loop marketing (CLM) tools, websites, apps, social media, webinars, etc. o Liaise with Medical Affairs and Legal departments to support product claims substantiation. Develop and maintain approved claimsdatabase. o Coordinate and generate mandatory label text (English Master Label - EML) for NAM. Proof and approve product labels and all labeling materials. o Communication to the Global team and NAM teams of any changes in the regulatory environment with new potential impacts for the Vitaflo business in the NAM region (i.e. new or changes in regulations, industry guidance from regulatory authorities, etc) o A key member of the NAM team - ensure that strategic and operational decisions take into account all regulatory aspects associated with the selling markets. o Form networks both within Vitaflo and NHSc - attend regulatory network meetings in the NAM region to ensure alignment and to maintain knowledge of regulatory environment and internal processes. o Support Marketing and Medical Affairs teams with development of product materials, competitive analysis, and training o Support Quality teams with exceptional release of specific product batches o Support the NAM team on the preparation for any internal audits and FDA inspections Experience and Education Requirements:
o Undergraduate (or Graduate) degree in life sciences or other relevant subject o Knowledge and understanding of the regulatory framework for foods in the US and Canada. o 3
years of working in a regulatory environment. o Experience of working in multidisciplinary teams and making decisions and contributions in a team environment. o Ability to influence senior management on strategic decisions based on actionable insights o Proficient in IT inclusive of Word, Excel, PowerPoint, Outlook o Ability to multitask, prioritize and work efficiently under pressure o Excellent communication skills, verbal and written o Ability to interact and build rapport with stakeholders at all levels of the organization Requisition ID:
148570 It is our business imperative to remain a very inclusive workplace. To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestle. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestle seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestle home.
Salary Range:
$80K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
o Determine the local requirements for registration documentation and the regulatory processes. Develop internal and external relationships and build knowledge of the regulatory environment within the US and Canadian territories. o Implementation of the Nestle compliance requirements for legacy and new products within the innovation pipeline for the US and Canada in collaboration with the Vitaflo Global Regulatory and R&D teams. o Implementation of regulatory and internal NHSc requirements to ensure compliance of all marketing materials shared externally, including:
- Printed; brochures, sales aids, recipe books, etc - Digital; Closed-loop marketing (CLM) tools, websites, apps, social media, webinars, etc. o Liaise with Medical Affairs and Legal departments to support product claims substantiation. Develop and maintain approved claimsdatabase. o Coordinate and generate mandatory label text (English Master Label - EML) for NAM. Proof and approve product labels and all labeling materials. o Communication to the Global team and NAM teams of any changes in the regulatory environment with new potential impacts for the Vitaflo business in the NAM region (i.e. new or changes in regulations, industry guidance from regulatory authorities, etc) o A key member of the NAM team - ensure that strategic and operational decisions take into account all regulatory aspects associated with the selling markets. o Form networks both within Vitaflo and NHSc - attend regulatory network meetings in the NAM region to ensure alignment and to maintain knowledge of regulatory environment and internal processes. o Support Marketing and Medical Affairs teams with development of product materials, competitive analysis, and training o Support Quality teams with exceptional release of specific product batches o Support the NAM team on the preparation for any internal audits and FDA inspections Experience and Education Requirements:
o Undergraduate (or Graduate) degree in life sciences or other relevant subject o Knowledge and understanding of the regulatory framework for foods in the US and Canada. o 3
years of working in a regulatory environment. o Experience of working in multidisciplinary teams and making decisions and contributions in a team environment. o Ability to influence senior management on strategic decisions based on actionable insights o Proficient in IT inclusive of Word, Excel, PowerPoint, Outlook o Ability to multitask, prioritize and work efficiently under pressure o Excellent communication skills, verbal and written o Ability to interact and build rapport with stakeholders at all levels of the organization Requisition ID:
148570 It is our business imperative to remain a very inclusive workplace. To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestle. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestle seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestle home.
Salary Range:
$80K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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