Regulatory Specialist

Geplaatst 15 June 2022
SalarisUp to €80000.00 per annum
LocatieNederland
Soort vacature Permanent
BedrijfssectorenLife SciencesKwaliteitscontrole / Veiligheid
ReferentieBBBH529733_1655295592

Vacature omschrijving


What about joining a growing international CRO which operates in more than 18 countries? Do you have a Life Sciences background, interest in (bio) pharmaceuticals and enjoying flexibility?

For our client, a CRO in pharmaceuticals, we are looking for a Regulatory Specialist homebased.

Our client is a clinical research organisation (CRO) in Europe. They operate in over 18 countries in the region with an experienced staff comprised largely of physicians and PhDs. They serve global pharmaceutical and biotechnology companies in the development of new medicines and modern medical technologies. The company has operations throughout Europe and since starting 18 years ago, they have expanded significantly.
Their international clients value the enthusiastic, flexible and quality-focused professional approach to meeting their needs.

For more detailed information please feel free to contact Mrs. Sari Steenhauer, tel. 0031 (0)6 33 13 77 46.

Position:
As a Regulatory Specialist you will be expected to actively participate in all start up activities and perform CA and EC submissions. You will be responsible for communication with Regulatory Authorities and Ethics Committees and function as an expert for Regulatory issues in the NL. Reporting to Clinical Operations Manager, you will be a key member of the Clinical Operations team in the country.
We are searching for ambitious and energetic person, able to undertake challenges in the project, push forward submissions and function well in the project team. The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.

Responsibilities

  • Participates in all activities that lead to start up of investigational sites;
  • Takes part in the communication with Regulatory Authorities and Ethics Committees;
  • Interacts with Customers when receiving requirements from Regulatory Authorities;
  • Provides interpretative assistance of guidance documents and regulatory rules and ensures their communication through company policies and procedures;
  • Provides training and support to CRAs in order to collect all necessarily documents for start up package and IP release;
  • Close collaboration with Regulatory Lead and Project Team during entire project.



Requirements

  • Excellent knowledge of the clinical trial process and ICH/GCP and local requirements/guidelines;
  • The position is suitable for candidates with some clinical research and RA and EC submissions knowledge and background such as Project/ Trial Assistants and CRAs;
  • Open to learn and develop;
  • Excellent organizational and time management skills;
  • Skills to handle multiple priorities and to work with deadlines and under pressure;
  • Excellent written and oral communication skills;
  • Fluent in written and verbal English and Dutch;
  • Computer skills.


What do we offer

  • Working with experienced and very professional and supportive team;
  • Possibility to grow within the Company;
  • Competitive remuneration;
  • Flexible working time;
  • Eligibility to the Company Bonus scheme;
  • Homebased.



Sari Steenhauer
T: 06 33 13 77 46.
When interested please react through the application process with your English resume.

About Kelly Services
It's more than a job. It's passion.
Our vision is to provide the world's best workforce solutions. We are authentic, the industry founder. We believe in relationships, not transactions. We value teamwork, realizing that we are stronger together than as individuals. We take seriously the promises we make. We are passionate, dedicated and driven to excel. With us it has never been about being the biggest. It has always been about being the best and doing the right thing.

At our core, we are a community. Each day we welcome into our community the varied talents of all people who embrace our culture of service, teamwork and integrity. We offer the opportunity to work with the best companies in the world, and to make a difference in the communities in which we live and work.

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