Regulatory Affairs Professional

Há 1 mês


Lisboa, Lisboa, Portugal Adecco Tempo inteiro
Regulatory Affairs Specialist

Are you an EU Market Regulatory Affairs expert looking for a new challenge in the pharmaceutical sector? We have a fantastic opportunity for you

Key Responsibilities:

  • Handling of all post-approval activities related to ANDAs, MAAs, ANDSs, variations/supplements, Annual Reports and deficiency letters according to regulatory guidelines;
  • Evaluate Change Controls, issue/update NRP's, prepare product information variations/labelling supplements, provide information for APRs, creation and revision of internal SOPs and DHFs;
  • Support the site on the launch of new products by performing all regulatory activities required;
  • Prepare, review and implement labelling;
  • Comply with defined KPls;

Requirements:

  • Master's degree in Pharmaceutical Sciences (Minimum);
  • Experienced in EU Market Regulatory Affairs (Preferred);
  • 4-6 years of professional experience;
  • Responsibility, proactivity and team work;
  • Maintains awareness of regulatory guidelines and updates;
  • Organization and planning capabilities;
  • Ability to work under pressure and meet deadlines;
  • Good analytical and negotiation skills;

Offer:

  • Direct contract with Client;
  • Salary adequate to the function and experience;
  • Life insurance;
  • Health insurance;
  • Annual Performance Bonus;

We believe in Talent without labels, and we are committed to non-discrimination, promoting diversity, inclusion and equity in the workplace.



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