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Tecnimede Group
Regulatory Affairs Specialist (M/F)Tecnimede Group • Sintra, Portuguese Republic, PT
Regulatory Affairs Specialist (M/F)

Regulatory Affairs Specialist (M/F)

Tecnimede Group • Sintra, Portuguese Republic, PT
Há +30 dias
Descrição do cargo

Tecnimede Group is a Portuguese multinational company with 40 years of experience, committed to improving and preserving human life and health through the development, production and marketing of pharmaceutical products, with a strong focus on quality and technological innovation. The Group covers the entire life cycle of medicinal products for human use, supported by continuous investment in research and development.

We are looking to reinforce our team with a Regulatory Affairs Specialist (M/F).

Responsibilities:

  • Ensure the coordination of all activities related to the regulatory area, ensuring compliance with applicable regulations and guidelines;
  • Prepare and submit pharmaceutical product registration dossiers for approval by authorities;
  • Keep up to datewith changes in regulations and guidelines and ensure the company is compliant;
  • Collaborate with internal teams in the pre-authorization phase (pharmaceutical, analytical and clinical development, and quality) and in the post-authorization phase (industrial production, pharmacovigilance, logistics, price and reimbursement and quality);
  • Participate in audits and inspections, providing support and necessary information;

-Develop and update locally controlled regulatory documentation (SOP's, training materials), ensuring they are updated and proactively identify procedural gaps to implement solutions in collaboration with all relevant stakeholders.

Requirements:

  • Academic training in Pharmacy, Chemistry or a related field;
  • Proven experience in the pharmaceutical regulatory area;
  • In-depth knowledge of pharmaceutical legislation and regulations;
  • Analytical and problem-solving skills;
  • Excellent verbal and written communication skills;
  • Ability to workindependently and in a team;
  • Fluency in English.

"In accordance with the provisions of the GDPR and other legislation in force on personal data protection, the contracting company guarantees that the processing of your personal data is lawful, fair, transparent, and limited to the purposes for which your data was collected."

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Regulatory Affairs Specialist (M/F) • Sintra, Portuguese Republic, PT

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