Regulatory Affairs Specialist - Zeewolde The Netherlands
Bioseutica looking for an experienced Regulatory Affairs Specialist in food/feed worldwide. The company has a number of Enzymes, Food and Feed additives, and APIs within its internationally marketed product portfolio.
Reporting to the Regulatory Affairs Director, the Regulatory Affairs Specialist will be joining a small regulatory team and will be responsible for preparing and maintaining the company's product registrations for designated territories in accordance with the guidelines laid down by food and feed national regulatory authorities and providing regulatory support to other areas of the business as needed.
Key Tasks and Areas of Responsibility
- Preparing and managing international regulatory submissions in accordance with the commercialization plan
- Reviewing data to ensure the suitability of dossiers/technical files for submission
- Renewing and updating product certificates/authorizations in the company's territories
- Providing regulatory support for out-licensing activities in EU and non-EU territories
- Performing regulatory compliance activities such as SOP revising, gap analysis, reviewing company specifications, change controls
- Reviewing and approving assigned promotional materials for company products
- Assist with regulatory requirements for labeling, annual product reviews, safety data sheets, other product documentation
- Participates in interactions and correspondence between the company and regulatory bodies
- Person Profile
- 4 years of global regulatory experience in the food/feed industry
- A life science degree.
Skills & Competences:
- Knowledge of relevant international regulations related to animal and human foods, with a special focus on EU and US regulations
- Possibly experience in active pharmaceutical ingredients
- Accuracy and attention to detail
- Professional Effective verbal and written communication skills
- Effective organizational and planning skills
- Good interpersonal skills, ability to work with others and independently
- Self-motivated, self-driven, and "can-do attitude"
- Computer skills (Microsoft office)
- Available to travel
- Fluent English (speaking and writing)
Please send your candidacy and your resume to firstname.lastname@example.org