Regulatory Affairs Manager/Officer

Regulatory Affairs Manager/Officer

ProductLife Group

Home Based, Poland

As a result of a new project we are now looking for a Regulatory Affairs Manager/Officer to perform all RA activities and interact with the health authorities on behalf of PLG customers.

Primary Responsibilities

  • Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements;
  • Assist the RA Platform/Hub Leader or a Senior RA consultant in pre-sales:
    • Ensure providing technical support to pre-sales;
    • Ensure adequate technical description of the proposals and support sales for quotation evaluation.
  • Gain regulatory authority approval;
  • Provide regulatory support to clients and associate companies;
  • Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling;
  • To represent PLG in regulatory associations, events and congress.

Candidate Profile

ProductLife Group applies the principles of equality and diversity in the workplace and opposes all forms of unlawful discrimination.

Education and Experience

  • Life science related field (pharmacist or minimum Bac+5);
  • 3 years minimum of working experience in a regulatory affairs position.

Skills

  • Ability to work well within a team;
  • Good attention to details;
  • Process oriented;
  • Excellent organizational skills.

Other

  • Knowledge of EU and Polish registration;
  • Experience in labelling in Poland;
  • Fluent in English and Polish for daily contacts.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

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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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