Regulatory Manager

hace 5 meses

Alcobendas, España Precision Medicine Group A tiempo completo

Precision for Medicine (CRO) are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland.

Position Summary:

The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function.

Essential functions of the job include but are not limited to:

Provides regulatory guidance throughout the clinical development life cycleCompile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as requiredDevelops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standardsServe as representative of Global Regulatory Affairs at project team meetings with both external and internal customersWorks within a project team, and where necessary, leads project for the region or globallyOversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programsMaintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.Assist in development of Regulatory Affairs Specialists and other operational area staff, as requiredProvide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted informationParticipates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approvalProvides ICH GCP guidance, advice and training to internal and external clientsServe as representative of Global Regulatory Affairs at business development meetings

Qualifications:

Minimum Required:

Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level Computer literacy (MS Office/ Office 365)Fluent in English

Preferred:

Graduate, postgraduatePossesses basic understanding of financial management

Other Required:

Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions

Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.

Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategyKnowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studiedKnowledge and expertise with relevant regulations and guidance supporting pharmaceutical developmentAvailability for domestic and international travel including overnight stays

Competencies

Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activitiesDemonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammatesAbility to manage multiple and varied tasks in a fast-moving environment, good record-keeping skillsExhibits high self-motivation, and is able to work and plan independently as well as in a team environmentMotivates other members of the project team to meet timelines and project goalsFlexible attitude with respect to work assignments, and new learningResolves project related problems and prioritize workload to meet deadlines with little support from managementFocuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effectiveCollects data of consistently high standardCommunicates effectively in the English language both verbally and in written formConducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency

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