Description
Mackinnon Bruce are proud to be partnered with a longstanding client, who develop, manufacture and distribute plant protection products across the EMEA region.
Purpose of Role
We are looking for a team player who also has a strong ability to project manage and navigate the complex EU regulatory system in an independent manner. Someone with a dynamic attitude to work, pro-active in problem solving and decision making. A person with experience of 5+ years in the Agrochemical Regulatory Industry with a knowledge of a variety of application submissions across the EU. A person with exceptional verbal and written communication skills capable of project managing large projects and working closely with the Regulatory Team to deliver these projects successfully. Close collaboration with our Commercial and Sales Team is an essential part of the role to maintain the integrity of our portfolio and produce viable marketing opportunities as well as a capability of developing relationships with key regulatory authorities across the EU to ensure delivery of authorisations as needed.
Key Responsibilities
Specifically, the role will involve the following:
- To prepare and project manage high quality registration dossiers for approval by Regulatory Authorities in Europe.
- Monitor the progress of New Product Development, Renewal and Re-Authorisation submissions, respond to queries as they arise and ensure that regulatory requirements are met in a planned and timely manner to avoid delays in approval.
- Work closely with Sales and Commercial teams to defend and extend the product portfolio.
- Support and collaborate effectively with third-party partners and projects.
- Represent our client on Task Forces, Data Sharing Groups, Industry Forums and international conferences.
- Commission studies with Contract Research Organisations. Monitor progress of studies to ensure target dates are maintained.
- Lead & contribute towards development of Regulatory Strategy.
- Keep up to-date with national and EU regulatory guidelines.
- Build and maintain strong relationships with Regulatory Authorities, Consultants, CRO’s, Internal departments.
- Mentor and Train junior Regulatory staff as required
- Comply with the Lean Principles being embedded throughout the Organisation.
- Participate in Continuous Improvement Initiatives to further develop department functions.
Competencies & Experience required
- 5+ years’ experience in European Regulatory Affairs
- Experience with both active substances and products
- Detailed understanding of IT Systems and Database Administration desirable
- Good time management and strong on attention to detail
- Excellent Communication skills
- Strong analytical and associated problem-solving ability
- Effective decision making
- Able to work under supervision or on own
- Proactive, taking initiative Standard Job Description Version: June 2021
- Knowledge and proficient in the use of SharePoint, Microsoft Word, Excel etc. Qualifications
- A bachelor’s degree, in Science or a related discipline.
