Bioseutica is looking for the following positions:
Bioseutica is looking for an experienced Regulatory Affairs Specialist in food/feed worldwide. The company has a number of Enzymes, Food and Feed additives, some APIs and a Veterinary Medicinal product (under development) 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 assisting in the preparation and maintenance of 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
- Reviewing data to ensure suitability of dossiers/technical files for submission;
- Support with preparing and managing international regulatory submissions in accordance with commercialisation plan;
- Renewing and updating product certificates/authorizations in 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 assigned promotional materials for company products for regulatory compliance;
- Assist with regulatory requirements for labelling, annual product reviews, safety data sheets, other product documentation;
- Participates in interactions and correspondence between the company and regulatory bodies.
- At least 4 years 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 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 organisational 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).
Only applications reflecting the required profile will be considered.
Interested candidates should send the CV to firstname.lastname@example.org