Senior Regulatory Affairs Associate
2 weeks ago
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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.
- 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.
- 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.
- 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.
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