Team leader (m/w/d) Global Regulatory Affairs
Location: Cologne – Germany; Job ID: 29203
The primary responsibility of the Team leader Global Regulatory Affairs is to develop and implement a regulatory strategy for the active ingredients and the respective products under responsibility and under the responsibility of team members to acquire new registrations and maintain the existing ones according to the national / zonal / regional requirements. This goal involves the development of regulatory data together with the experts, preparation and submission of registration dossiers, support of the country teams.
Responsibilities:
- Manage a team of Global Regulatory Affairs Managers to
- support team members to work according to the Job Description of the “Global Regulatory Affairs Manager” (see next page).
- focus with the team members on a transparent way of working to share with all involved internal stakeholders AI and product related information, e.g. sharing of information on sharepoint, active as well as regular communication of project updates to the internal stakeholders.
- develop team members to improve their regulatory knowledge, communication skills and soft skills in general.
- provide to the team members open and honest feedback in regular meetings as well as in success factor (e.g. mid- and end-year review) to further develop the skills of team members. Work with Individual Development Plans for team members.
- Support actively the further development of the Adama regulatory community on global level.
- Develop and implement a regulatory strategy for the active ingredients and the respective products under responsibility and under the responsibility of team members (e.g. GAP, harmonized risk assessment strategies) in cooperation with the AI / product allocated experts and/or consultants, including preliminary risk assessments to highlight potential regulatory opportunities and risks.
- Take care with the team members on the preparation of the (Sub-) Offering Committee(s) and, after approval by the Offering Committee(s), for the preparation of new registration files or the maintenance of existing registrations.
- Overseeing the budget status of the projects managed by the team.
- Mentor team members to work according to the agreed working principles (rules & responsibilities) between the different regulatory and scientific teams as well as in all project teams (global AI project, European AIR projects and dRR preparation projects).
- Be updated with the specific local requirements and guidelines.
Reporting and relationship in the Organization:
- Working under the direct supervision of the Head of Global Regulatory & Scientific Affairs (report on progress and status of projects, esp. on upcoming issues, consult on decisions to be taken as needed, highlight alignment needs between the Global Regulatory Affairs teams, etc.).
- Working together with other Global Registration Managers and the other Team Leaders in the organization (within Global Regulatory Affairs as well as the Science teams) to share knowledge (e.g. new requirements, new information from authorities) and to make the best use of the existing knowledge in the organization.
- Working with other departments in the organization such as the different Portfolio & Innovation teams, Country/Regional Registration Managers, Formulation Supply, AI Production and business functions.
Qualifications:
- Strong ability to lead and motivate team members.
- At least 5 years of experiences as Regulatory Manager with full regulatory responsibility in a region 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).
- Project and task management skills.
- Good organizational skills with ability to multi-task on several projects and independent working.
- Ability to recognize and concentrate on important and relevant aspects.
- Reliability of reporting.
- Strategic thinking.
- Interpersonal skills.
- Networking ability (both internal/external).
- It is expected that the Team Leader is working full time and is present at least 3 days per week at ADAMA's office in Cologne.