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Senior Regulatory Affairs Manager

  • Standort:

    Leiden, Niederlande

  • Kontakt:

    Nicol Heijtbrink

  • Jobtyp:

    Temp to Perm

  • Kontakt Telefon:

    +31 (0)20 406 97 50

  • Branche:

    Life Sciences

  • Kontakt-E-Mail:

    nicol_heijtbrink@oxfordcorp.com

Are you an experienced regulatory affairs manager, in the pharmaceutical industry, searching a new challenge? Then we are looking for you!


Job Description
Our client is an open, progressive, and international company, working towards a sustainable world. In this role you will manage regulatory affairs for the therapeutic products. This can range from early stage clinical development till commercial products. You work on the planning and preforming of regulatory strategies, and carrying responsibility for the RA department. You combine the best and newest scientific insights with regulatory expertise to meet the quality and business requirements. With the other regional RA managers you contribute to mapping out global strategies, programs and products. You provide input for decision making processes. Furthermore your responsibilities include communication with regulatory authorities, product related communications, and interaction with product team members. You are a real problem solver and provide solutions for complex issues. If your interest is sparked, apply below!

Responsibilities

  • Ensure that all qualifications and validations meet regulatory requirements;
  • Managing quality guidelines of the facility, equipment and process;
  • Work on the new facility, making sure all operations are fit for use and compliant with GMP;
  • Leadership, coaching staff in quality and safety requirements;
  • Risk assessment and acting accordingly;
  • Partake in meetings, providing input for continuous improvement and quality;
  • Organize your work and carry responsibility for you decisions;


Requirements

  • Bachelor degree or preferably master in sciences or equivalent;
  • Previous experience in a similar position is required, this is not a entry level position;
  • Expertise in the field of quality compliance with regulations such as GMP, GLP and ICH;
  • Proven experience interacting with regulatory authorities and stakeholders;
  • Good skills in communication, negotiation, and problem-solving;
  • A scientific mindset and a strong technical background;



Benefits

  • Contract: Start on a year contract trough Oxford Global Resources, possibility for extension;
  • Salary: €4000- €7000, based on experience;
  • Working hours: fulltime, 40 hours per week;
  • Region: Leiden, hybrid working possible;

Vacancy number: 20689;