Senior Regulatory Affairs Manager - Kennesaw, United States - The Judge Group

Description

Job DescriptionSenior Regulatory Affairs Manager - Kennesaw, GAThis is a full-time, exempt level position

Position Summary:

The Senior Regulatory Affairs Manager is responsible for the assessment of regulatory permissibility and suitability of the H&W portfolio and the successful interaction between the global RSA community and cross-functional teams to ensure regulatory compliance of the products in the North American Market.

The Senior Manager works in conjunction with the Global Director or Regulatory Compliance H&W and the Director of RSA for North America, to leverage the registrations, renewals and variations of the products in the marketJob Responsibilities:

Leverage global regulatory compliance of the H&W portfolio by owning the assessments of permissibility and suitability in North America (NA) and coordinate the assessments with regional SMEs outside the region to unlock key markets according to the business strategy.

Own the assessment and approval of the steps that require regulatory input and are related to innovation and/or permissibility and suitability of the H&W portfolio.

Ensure regulatory compliance for ingredients and products throughout their lifecycle and ensure all regulatory documents are up to date, traceable and available to all RSA team members.

Leverage regulatory feedback on topics related to claims and marketing materials in US (in collaboration with the Regulatory Scientific Affairs team) and coordinate input from regional SMEs.

Develop regulatory requirements and other relevant guidelines applicable to H&W portfolio and provide guidance to relevant colleagues including S&T, RSA, Legal, Marketing and Commercial.

Own the Regulatory Risk Assessments related to the permissibility and suitability assessments of the H&W portfolio according to the current process and propose technical mitigation actions as applicable.

Own the preparation, review and submission of regulatory dossiers and applications for the H&W portfolio in North America and ensure accuracy, completeness and compliance with regulatory requirements in close collaboration with internal SMEs and external experts.

Act as the primary point of contact for regulatory agencies.

Unlock regulatory requirements for ingredients and products in relation to H&W portfolio compliance by leading the management of relevant information/documentation provided to appropriate stakeholders.

Leverage the regulatory service ADM provides to its customers in accordance with ADM policies and processes by providing regulatory advice.

Keep abreast of regulatory requirements, guidelines and industry best practices related to H&W ingredients and make strategic recommendations to senior management as risks and opportunities arise.

In conjunction with relevant RSA colleagues, develops and manages regulatory positions by writing and reviewing regulatory documents (SOPs, Work Instructions, RSA statements and guidelines) according to the Document Management System.

Carrying out any work which the company may from time to time deem necessary.


Required Skills:
Ability to manage multiple projects and prioritise workload.

Highly organised and able to work according to strict deadlinesStrong problem-solving and decision-making skillsAbility to develop and leveraging networks within various stakeholders (internally and externally).

Education Requirements:

Technical/scientific studies:
Degree in Food technology or law, Chemistry, Biology or Biochemistry.

Professional level capability in EnglishKnowledge of relevant regulations and standards for the food industryRequired Experience:
Minimum of 5 years of experience in a regulatory role, in US within the food supplements industry

Desired Experience:
Experience in Food and Beverage (Desirable).

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REF:
83651BR

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