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Regulatory Compliance Technician (m/f)

On-site in Coimbra·Added 13 days ago (last checked 22 Oct)

Bluepharma

11 open roles

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Our summary

Work mode
On-site, Coimbra
Experience
2+ years

Skills

This job advert was originally written in Portuguese.

The role

Main Responsibilities

  • Research, analyze and interpret regulatory standards and requirements from national and international competent authorities;
  • Manage registration processes in different markets with different regulatory requirements;
  • Participate in the definition of the Regulatory Strategy in close collaboration with other departments and Partners;
  • Identify and consolidate relevant documentation for regulatory events;
  • Draft and/or review sections of Module 2 and 3 (CMC) of the medicinal product dossier and prepare supporting documentation for regulatory events;
  • Analysis, collection of documentation and response to requests for information from competent authorities or clients;
  • Ensure product compliance from a regulatory standpoint.

Requirements

  • Bachelor's degree or Integrated Master's degree in Pharmaceutical Sciences or Science Area;
  • Experience in the Pharmaceutical sector in the regulatory area (minimum 2 years);
  • Professional experience and knowledge of regulatory requirements in EU / US / CAN and/or other territories will be valued;
  • Fluency in spoken and written English;
  • Advanced knowledge of Office;
  • High communication and management skills;
  • Capacity for strategic planning and meeting established deadlines;
  • Responsibility and organization;
  • Attention to detail and high analytical and problem-solving skills;
  • Flexibility and availability;
  • Ease of inter-relationship with all levels of the organization and ability to remain calm, professional, diplomatic and positive;
  • Initiative, proactivity and ability to solve problems;
  • Ability to work in a team.

About Bluepharma

Industry
Pharmaceuticals
Website
bluepharma.pt
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