Czech-Slovak Regulatory Manager

ManagerManagerFull TimeRemoteLeadTeam 501-1,000

Location

Czechia + 1 moreAll locations: Czechia | Slovakia

Posted

3 days ago

Salary

0

Seniority

Lead

No structured requirement data.

Job Description

Czech-Slovak Regulatory Manager

Staphyt

Role Description 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. 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 - 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, including: - 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. - 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, promptly set up the project on our systems, plan the project timetable and arrange for the team to start work without delay. - Check the project teams timesheets against the budget and manage any variances. - In liaison with the PMO, request invoices in line with the billing schedule agreed and provide key information to the invoicing team. - Closely monitor compliance with budget, scope, quality and deadline and take corrective action ahead of any variation. - Alert the client, in advance, if the agreed budget or timelines are going to be exceeded. Consult the BDM where necessary and ensure 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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