Regulatory Scientist - Safety
Kemin (www.kemin.com) provides “inspired molecular solutions” specifically developed to provide nutrition and health benefits for humans and animals. Committed to feed and food safety, Kemin maintains top-of-the-line manufacturing facilities where approximately 500 specialty ingredients are made for the global feed and food industries as well as the health, nutrition and beauty markets. A privately held, family-owned and operated company, Kemin has more than 2,000 employees and operates in more than 90 countries with manufacturing facilities in Belgium, Brazil, China, India, Italy, Russia, Singapore, South Africa and the United states.
The Regulatory Affairs Scientist will be involved in designing and monitoring animal trials related to the safety for the animal, consumer, user and environment. She/he will also be responsible for maintaining product registration approvals by ensuring compliance with legal requirements and implementing post-approval changes required, as well as registering new products and ensuring compliances with regulatory requirements in the EMENA region.
- Design, Planning, Follow-up and analysis of animal trials, review trial reports
- Writing and co-ordination of registration dossiers for both EU and other countries in the EMENA region
- Building a network throughout the EMENA region with research institutes and other parties involved in animal studies for product registration process
- Conducting regulatory research including locating regulations (Regulatory Intelligence)
- Understanding regulatory requirements and relevant government regulations in the EMENA region, as well as stay current on regulatory issues affecting Kemin products in these countries
- Working with the Sales & Marketing organizations in implementing the regulatory strategy to achieve timely filing and approval of new and existing products for each country in the EMENA region in accordance with business objectives
- Focus and prioritize activities of assigned projects and assume responsibility for their success
- Assist with regulatory submissions, and prepare product registration dossiers to obtain and maintain regulatory approvals for Kemin products under supervision
- Serve as regulatory liaison with marketing and research department for the development of regulatory plans in conjunction with new product development
- University degree (Master or PhD depending on experience) in a relevant scientific field, preferably in animal nutrition, biochemistry, biomedical science or comparable discipline, preferably with some working experience in a regulatory or related position
- Proven experience related to safety trials (lab animals and/or farm animals)
- Fluency in English is required
- Thorough knowledge of working with Excel spreadsheet preferable
- Familiarity with regulations in EU and non-EU countries is a plus
- Familiarity with REACH, CLP or EFSA guidelines is a plus
- Experience in reviewing and evaluating scientific literature with demonstrated ability to analyze and assemble/synthesize scientific information from many sources, including identification of information gaps and future research needs
- Excellent attention to detail required, reliable, highly motivated, ability to work independently and interacts well in a team environment
- Possess excellent verbal, written and interpersonal communication skills, demonstrated good technical writing skills, ability to present ideas effectively
- Excellent organizational and time management skills, demonstrated prioritizing, planning and project management skills
Offer: This position is based in our EMENA headquarters in Herentals, Belgium.
Interested: Please visit us at www.kemin.com or sent your CV to firstname.lastname@example.org.
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