Location: Cologne – Germany
Job ID: 30091
The primary responsibility of the Global Regulatory Affairs Manager is to develop and implement a regulatory strategy for the a ingredients and the respective products under responsibility to acquire new registrations and maintain the existing ones according to the registration national / zonal / regional requirements. This goal involves the development of regulatory data, preparation and submission of registration dossiers, support of the country teams and represent the company in all matters related to the active ingredient and the respective products.
Responsibilities:
* Develop and implement a regulatory strategy for the active ingredients and the respective products under responsibility (e.g. GAP, harmonized risk assessment strategies) including preliminary risk assessments to highlight potential regulatory opportunities and risks
* Manage the registration data package for the relevant active ingredients and the respective products including gathering of all available information from different disciplines (chemistry, development, toxicity, field residues, environmental, eco-toxicity etc.) and internal departments for the preparation of new registration files or the maintenance of existing registrations
* Project Management of the data package generation under global regulatory considerations, especially to prevent duplication
* Find contractors & consultants and manage the production of registration files according to country/area specific registration requirements in cooperation with experts
* Represent ADAMA as the registration manager on regional and global level
* Respond to regulatory issues and timely inform business on potential business impacts
* Support the existing registrations and acquire new registrations following the business needs.
* Primary contact person for all regulatory aspects for the internal stakeholders (e.g. e.g. Development, Business, country organizations)
* Provides strategic direction to align the needs of the business and the development functions in consideration of possible regulatory limitations
* Represents the company as the expert on the AI and products under responsibility and represent the company in official meetings with authorities or cooperation partners
Qualifications:
* At least 3-5 years of experience as Regulatory Manager with full regulatory responsibility in a country / area with high regulatory requirements (e.g. Europe, Brazil, US), preferred with experiences on global level
* Strong knowledge on registration / re-registration of Active Ingredients in a country / region with high regulatory requirements
* Good verbal and written communication abilities in English (concise summarization of technical material, reporting on developments)
* B.Sc., M.Sc. or Ph.D. or similar degree in Life Sciences (e.g. Chemistry, Biochemistry, Biology, Agriculture)
* Regulatory experiences with biologics - an advantage.
* Good organizational skills with ability to multi-task on several projects and independent working
* Strategic thinking
* Interpersonal skills
* Networking ability (both internal/external)