The Junior Regulatory Manager we are looking for will coordinate and manage regulatory activities of Crop Protection, Conventional Row Crops, Vegetables seeds and Traits’ portfolios in the country by effectively following the local Regulatory Science and Compliance activities. He/she will also conduct activities regarding the maintenance, defense and re-registration of existing products in the country and will maintain the Regulatory databases required to ensure efficient running of the business and compliance of data.
- Ensures preparation, with minimum oversight, filing and tracking of regulatory applications according to the agreed project plans as well as to provide update on the progresses. Keeps track of and maintains the existing registrations.
- Ensures regulatory compliance throughout the life cycle of Bayer’s products by taking role in stewardship activities on a project/need basis.
- Ensures that the business is provided with authorized label text for allocated products and advises on critical changes and timelines that have a business consequence. Maintains awareness of the critical issues for the assigned products and keeps the business informed as required.
- Handles all regulatory questions concerning the registration application during the (re)evaluation processes and after approval of the products in order to meet the conditions for prolonging and maintaining the registration of products.
- Is responsible for the submission, follow up and defense of allocated regulatory dossiers. Provides all information required for the legal compliance (e.g. for labels) for the products under his/her responsibility.
- Negotiates with Government officials on simple /administrative regulatory matters, to ensure timely approval and authorization, for the assigned active substance and product responsibilities.
- Maintains a record of all submissions, questions, responses and authorizations in the respective regulatory databases, both local and regional for CP and seeds.
- Ensures that newly created or modified Safety Data Sheets conform to the authorized product label text and are circulated, as required by the business.