Junior Regulatory Affairs Specialist NAM/SAMPlantation, Florida
AB Enzymes is a subsidiary of Associated British Foods PLC (London UK), reporting into the Associated British Foods Ingredients Division (Paris, France), and it is a leading company in the enzymes business operating from sites worldwide, with Head Office in Germany. We are a reliable partner for customers in the food, feed and industrial enzymes businesses. Product excellence and innovation are among our key strengths and our customers’ value these highly.
We are looking for an experienced business partner for the role of Junior Regulatory Affairs Specialist NAM/SAM (Located in Plantation, Florida). The role will assist in the preparation and coordination of Regulatory Affairs submissions in the NAM and SAM region (Canada, USA, Mexico and Brazil currently) to ensure corporate goals are achieved in a timely and compliant manner. You will operate within a highly profitable growing business, whilst being part of one of the UK’s largest PLC’s.
- Assist with the writing and assembly of regulatory dossiers in the NAM and SAM region.
- Follow emergence of new regulatory requirements and their impact on regulatory projects.
- Active participation in the Enzyme Technical Association.
- Support regulatory management in other tasks, such as product documentation, customer service and special projects.
- Assist in the development of internal regulatory policies and procedures.
- Communication with relevant authorities regarding our regulatory dossiers.
- For the time being the focus will be on the food area, but the role might extend to regulatory sub-missions in line with chemical legislations.
Required Qualifications and Key Skills
- 2-3 years of experience in USA and Canada food additive/processing aid regulatory environment.
- Knowledge of US FDA Food and Drug Regulations (21 CFR), Health Canada Food and Drug Regulation, Brazilian Food Regulations (ANVISA), Mexican Food Regulations (COFEPRIS) considered an as-set.
- You should bring a strong scientific background and solid knowledge of the regulation of food ingredients in the respective countries, specifically food additives/processing aids.
- Exposure to industry groups, government authorities (e.g. FDA), trade associations and other scientific societies.
- Post-Secondary Education in Science, Biology, Nutrition or related field.
- Fluent in English and Spanish (written and spoken) required, Portuguese considered an asset.
- Strong technical writing skills.
- Strong team player, results-driven, multi-tasker who requires minimal supervision and can work on multiple projects under tight deadlines.
- Outstanding communication, and problem-solving skills; able to work in a remote team with minimal supervision.
- Ability to manage projects complex projects and prioritize actions based on clear and pragmatic criteria.
- Proactive and able to continuously manage change.
- Proficient in the use of MS Office Suite.
- Availability for national and international travel, no more than 10%.