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Regulatory Senior Associate
4 weeks ago
Senior Regulatory Affairs Manager - Kennesaw, GA
This 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 market
Job 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.
- Ability to manage multiple projects and prioritise workload.
- Highly organised and able to work according to strict deadlines
- Strong problem-solving and decision-making skills
- Ability to develop and leveraging networks within various stakeholders (internally and externally).
- Technical/scientific studies: Degree in Food technology or law, Chemistry, Biology or Biochemistry.
- Professional level capability in English
- Knowledge of relevant regulations and standards for the food industry
- Minimum of 5 years of experience in a regulatory role, in US within the food supplements industry.
- Experience in Food and Beverage (Desirable).
ADM requires the successful completion of a background check.
REF: 83651BR
About ADM
At ADM, we unlock the power of nature to provide access to nutrition worldwide. With industry-advancing innovations, a complete portfolio of ingredients and solutions to meet any taste, and a commitment to sustainability, we give customers an edge in solving the nutritional challenges of today and tomorrow. We're a global leader in human and animal nutrition and the world's premier agricultural origination and processing company. Our breadth, depth, insights, facilities and logistical expertise give us unparalleled capabilities to meet needs for food, beverages, health and wellness, and more. From the seed of the idea to the outcome of the solution, we enrich the quality of life the world over. Learn more at www.adm.com.
#IncludingYou
Diversity, equity, inclusion and belonging are cornerstones of ADM's efforts to continue innovating, driving growth, and delivering outstanding performance. We are committed to attracting and retaining a diverse workforce and create welcoming, truly inclusive work environments - environments that enable every ADM colleague to feel comfortable on the job, make meaningful contributions to our success, and grow their career. We respect and value the unique backgrounds and experiences that each person can bring to ADM because we know that diversity of perspectives makes us better, together.
We are committed to ensuring all qualified applicants receive consideration for employment regardless of race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.
We welcome everyone to apply, especially those individuals who are underrepresented in our industry, as we strive to ensure our workforce represents the world that we help to feed: people of color, women, gender non-conforming, LGBTQIA+, veterans and persons with disabilities. For more information regarding our efforts to advance Diversity, Equity, Inclusion & Belonging, please visit our website here: Diversity, Equity and InclusionADM.
Benefits and Perks
Enriching the quality of life for the world begins by taking care of our colleagues. In addition to competitive pay, we support your diverse needs with a comprehensive total rewards package to enhance your well-being, including:
- Physical wellness - medical/Rx, dental, vision and on-site wellness center access or gym reimbursement (as applicable).
- Financial wellness - flexible spending accounts, health savings account, 401(k) with matching contributions and cash balance plan, discounted employee stock purchasing program, life insurance, disability, workers' compensation, legal assistance, identity theft protection.
- Mental and social wellness - Employee Assistance Program (EAP), Employee Resource Groups (ERGs) and Colleague Giving Programs (ADM Cares).
- Paid time off including paid holidays.
- Adoption assistance and paid maternity and parental leave.
- Tuition assistance.
- Company-sponsored training and development resources, such as LinkedIn Learning, language training and mentoring programs.
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