Senior Regulatory Affairs Associate
4 weeks ago
Job Description
Senior Regulatory Affairs Associate - Kennesaw, GA
This is a full-time, exempt position.
Job Purpose:
The Senior Regulatory Affairs Associate owns/leverages the registrations, renewals and variations of the products in the market and works in conjunction with the RSA Strategy and Development team to assess and ensure timely and accurate submission of regulatory documents.
The Associate has a strategic and operative responsibility for executing all regulatory interactions and initiatives in relation to the H&W portfolio at ADM Denmark.
Main Responsibilities:
Develop and implement regulatory compliance strategies for the H&W portfolio at ADM Denmark, in alignment with the global regulatory policies and guidelines and ensures compliance with all relevant regulations and standards by providing regulatory guidance to cross-functional teams.
Leveraging the operational model of the Regulatory Compliance team by ensuring that ingredients and products are assessed to ensure regulatory compliance throughout the whole life cycle and the documents shared to customers for regulatory purposes are current and available to all RSA team members.
Act as the primary point of contact for regulatory agencies or work in conjunction with colleagues as appropriate and manage all regulatory interactions, including submissions, communications and meetings to achieve new/renew marketing authorisations of H&W products.
Liaising with clients, key account managers and colleagues (regulatory and other departments) to determine priority regulatory requirements in line with department and company goals. Communicate regularly with key account managers and other internal stakeholders to provide updates by interpreting, and communicating status of relevant KPIs using relevant tools (such as SalesForce and the Hopper).
Prepare, review and submit regulatory documents, including registration dossiers, labeling, marketing materials in compliance with regulatory requirements and timelines.
Lead and liaise with RSA colleagues to keep abreast of EU and, where relevant, international legislation, guidelines and practices for general food, food supplements, food additives and pharmaceutical products, manufactured or distributed by ADM and advise the organization on the impact of these on the H&W portfolio.
Develop and manage 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.
Skills & Abilities:
Ability to manage multiple projects and prioritise workload.
Strong problem-solving and decision-making skills
Strong attention to detail and ability to analyse complex information
Ability to work independently and in a team environment.
Education & Experience:
Technical/scientific studies, Degree in Food technology, Chemistry, Biology, Pharmacist or Biochemistry.
Professional level capability in English and Danish (Danish is a plus)
Minimum of 3 years of experience in a regulatory, technical or quality role in EU, UK, LATAM, US or APAC preferably within the food and beverage or pharmaceutical industry.
Excited about this role but don't meet every requirement listed? Studies show that often applicants will self-select out if they don't check every box. We encourage you to apply anyway. You may be just the right candidate for this role or another one of our openings.
ADM requires the successful completion of a background check.
REF: 83604BR
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).
Additional benefits include:
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.
*Benefits may vary for bargained locations, confirm benefit eligibility with your recruiter.
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