Sr. Regulatory Affairs Specialist EU
Functieomschrijving
Have you earned your experience in Regulatory affairs. (+ 10 years), Can you lead a team?
Do you have hand on experience with European regulatory bodies such as ECHA and EFSA? Like to manage a team of Regulatory Affairs specialists? Then this is the position for you! J ob Summary: Our company is seeking a Senior Regulatory Affairs Specialist to join our team in Europe. The successful candidate will be responsible for managing biocide and pesticide product registrations and regulatory compliance in accordance with European regulations. Job description:
Do you have hand on experience with European regulatory bodies such as ECHA and EFSA? Like to manage a team of Regulatory Affairs specialists? Then this is the position for you! J ob Summary: Our company is seeking a Senior Regulatory Affairs Specialist to join our team in Europe. The successful candidate will be responsible for managing biocide and pesticide product registrations and regulatory compliance in accordance with European regulations. Job description:
- The primary responsibility is to work with local evaluating competent authorities and with the European registration authorities (ECHA & EFSA) to register and gain approval of biocidal and pesticidal active substances, products and emergency authorisation permits for the EU markets.
- The person must have strong knowledge and experience of the BP and PPP regulations. Experience in registering fumigants is highly preferred.
- Liaise with regulatory authorities and respond to requests for information and data.
- The job will also involve working with overseas registration agencies and consultants for product approval in other countries.
- Responsible for preparing dossiers for new active substances and formulated products, identify data requirements, assessment of requirements for registration, review the overseas registration data and modify for local submission, organise local scientific trials, identify local testing lab, regular follow-up with testing lab, gain approval to import product for local trials, attend meetings with registration authority and willing to travel.
- Preparing a Gantt chart encompassing all activities, responsibilities, and timelines of registration
- Maintain regulatory files/database and chronologies in good order.
- Responsible for timely registration of the product portfolio
- Maintain current knowledge of local and international regulations, guidance, and standards applicable to the company product portfolio.
- Be responsible for starting the product scheduling to the final registration certificate of new fumigants, biocides, pesticides, and other chemical products for EU markets.
- Ability to solve problems, show judgement, pay attention to fine details and make decisions based on sound science and risk analysis.
- Or focus is on: to be a leader in environmentally sustainable products and services to the pest control and biosecurity sectors.
- Our Vision: To provide quality services that exceed the expectations of our all customers and partners
- Our company statement: To build long-term relationships with our customers and partners by providing exceptional services through the use of quality processes, offering practical innovative solutions, and utilizing advanced 21st-century chemicals.
Profiel
Qualifications:
- Bachelor's or Master's degree in biology, toxicology, environmental science, or related field
- Minimum of 5 years of experience in pesticide and biocide product regulatory affairs in Europe
- Knowledge of European biocide and pesticide regulations
- Excellent communication skills and ability to work collaboratively with internal and external stakeholders.
- Strong analytical and problem-solving skills
- Fluency in English is required, knowledge of other European languages is an asset.
Aanbod
We offer:
- a dynamic and challenging full-time position in a growing company
- competitive salary and benefits package
- opportunities for professional growth and development
- a supportive and collaborative work environment
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