Regulatory Affairs Manager

Regulatory Affairs Manager

ProductLife Group

Prague, Czech Republic

As a result of a new project we are now seeking a Regulatory Affairs Manager responsible for ensuring the delivery of regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers.

Primary Responsibilities

  • Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements;
  • Gain regulatory authority approval;
  • Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives;
  • Provide regulatory support to clients and associate companies;
  • Liaise with external regulatory authorities as required;
  • Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling;
  • Review tasks for, support and mentor Regulatory Affairs Officers and Associates;
  • Assist the RA Platform/Hub Leader or a Senior RA consultant in presales:
    • Ensure providing technical support to presales;
    • Ensure adequate technical description of the proposals and support sales for quotation evaluation;
    • Control that invoicing is correctly set.
  • Contribute to data entry in PLG tools enabling measurements and measure KPI/metrics for regulatory services supplied by the platform/hub;
  • To produce and review SOPs relating to the Regulatory Affairs function;
  • To participate in training as required;
  • To provide in-house training as required for staff in the Regulatory Affairs group;
  • To contribute to the production of client documents and reports;
  • To support the Pharmacovigilance group in the production of Regulatory Authority and Ethics Committee documentation;
  • To liaise with other group companies on regulatory issues and to provide support for their activities in the regulatory field;
  • Contribute to follow up of the quality of service of regulatory partners working with the Platform/the Hub;
  • To represent PLG in regulatory associations, events and congress;
  • To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.

Candidate Profile

Education and Experience

  • Life Sciences related fields Master’s degree (Pharmacist or minimum Bac+5);
  • Minimum of 4 years ‘experience, this experience should include a proven understanding of the regulatory process and experience in leading a project to successful completion;
  • Experience in a regulatory affairs department;
  • Knowledge of EU and Czech/Slovakian registration;
  • Experience in Labelling in Czech Republic.

Key skills

  • Excellent organisation skills;
  • Ability to work well within a team;
  • Good attention to detail;
  • Effective oral and written communication skills;
  • Fluent in English and Czech/Slovakian for daily contact with internal and external partners.

Core Competences

  • Good interpersonal skills;
  • The ability to co-ordinate, manage and motivate a team;
  • Process orientated.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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