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AI Summary
Staphyt supports its clients in the agroscience, biocide and chemical sectors to compile their registration dossiers and to obtain approval for their active substances and market authorisations for their products. In the frame of this job, the overall responsibility is to manage the PPP national submissions in the Czech Republic and Slovakia and to ensure close, flexible communication with clients.
Job role:
To provide regulatory advice to clients, to assist them in understanding the regulatory requirements and processes that need to be met to deliver their objectives in the Czech Republic and Slovakia.
To coordinate the delivery of work through a team of scientific experts when required.
To prepare and submit the dossiers in Cz and Sk authorities
You will:
Initiate, lead and manage the work agreed with a client (under a signed contract), within the required budget, timescale, scope and quality. Manage changes to scope, budget and time in accordance with agreed internal procedures
Be the main point of contact with the client and regulatory authorities, obtaining additional information and responding to requests as promptly as possible.
Attend meetings with the client or regulatory authorities as necessary.
Liaise with relevant Team Leaders to request that Scientific Experts with the right experience, expertise and availability are allocated to the work when required.
Provide the allocated team with all the necessary information needed to undertake the project, including agreeing the project strategy.
Facilitate direct contact between the client and Scientific Experts when needed.
Manage the quality of the work, to ensure that client expectations are met.
Responsibilities:
1) Technical :
Ensuring that advice provided to clients is well researched and accurate.
Being in direct contact with the Cz and Sk Authorities
Ensuring that the project is performed in accordance with the regulations and any guidance. This includes:
Maintaining an understanding of the regulatory changes on the horizon that will impact on the client's objectives.
Alerting the Team Leader, Senior Regulatory Manager and BDM in the event of any technical problems on a project, or in the relationship with the client.
Using the regulatory technical tools and standard procedures (software, file sharing systems, ...) and processes.
Coordination of the various Scientific Experts required to undertake the work, including a kick off meeting and regular review meetings.
2) Administrative:
Supporting the BDM by liaising with existing clients regarding proposals for new work and preparation of quotes (Business Development Manager takes final decisions on price).
In liaison with the Project Management Officer (PMO), confirming the invoicing address and billing arrangements before the quote is issued.
On acceptance of the quote, ensuring that the BDM is updated and that the Regulatory Sector TL is aware.
When identified as a PM, you will promptly set up the project on our systems, plan the project timetable and arrange for the team to start work without delay. You will check the project teams timesheets against the budget and manage any variances.
In liaison with the PMO, requesting invoices in line with the billing schedule agreed and providing key information to the invoicing team.
Closely monitoring compliance with budget, scope, quality and deadline and taking corrective action ahead of any variation.
Alerting the client, in advance, if the agreed budget or timelines are going to be exceeded. Consulting the BDM where necessary and ensuring that the client agrees to any changes.
Interactions
Team Leader.
Regulatory Manager/Senior Regulatory Manager/Referent - work closely together.
Scientific Team Leaders.
Scientific Experts.
Business Development Managers.
Clients.
Personal Skills
Proven experience and strong technical skills in one or more areas of the expertise required
Experience in Cz requirements is a must, experience in Sk is a good-to-have.
English written (++), read, spoken
Ability to carry out audits, studies and technical advice in their field of expertise
Capacity for analysis and organization
Curiosity
Accuracy
Autonomy
Ability to work as a team
Good interpersonal skills
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