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Regulatory Affairs (RA) Officer

  • Lab Ofichem
  • Lab Ofichem, Ter Apel
  • Parttime-Fulltime
  • 23 Jul 2021

Job description

The RA Officer carries out the work for Laboratorium Ofichem B.V. This is a part-time position for 24 hours a week with the possibility of full-time position in combination with tasks for the QA department. The position of RA Officer is a versatile function, in which you are responsible for the correctly compiling information and registration of API registration files.

Duties and Responsibilities of the RA Officer:

  • Ensure that the APIs produced by Laboratorium Ofichem BV are registered with international governments as part of a drug registration;
  • Developing and maintaining active substance master files ( ASMFs );
  • Obtaining CEPs and maintaining CEP records;
  • Issuing of letters of access, declarations of access and other declarations;
  • Supervising legal guidelines and advising internal organizations in the field of RA
  • Drafting and management of confidential disclosure agreements (CDA 's);
  • Supporting customers with registrations;
  • Communication with customers and registration authorities regarding registrations;
  • Inform customers and authorities of variations ;
  • Keeping up with monograph changes as well as changes in legislation and regulations.

Our offer:

A competitive salary with secondary employment conditions.

Company Profile

The Ofichem Group produces, develops and distributes active pharmaceutical ingredients (APIs ) for both humans and animals. These active substances are distributed worldwide to pharmaceutical manufacturers. The production of APIs is done in accordance to the Good Manufacturing Practices (GMP) guidelines by the business unit Laboratory Ofichem . The Ofichem group also has its own laboratory that not only analyzes its own APIs, but also performs analyses for third parties. The Ofichem Group also has its own R&D group that is continuously developing new products.

The business unit, Lab. Ofichem B.V. (Production API) produces a wide range of pharmaceutical products, including APIs for antibiotics (sulfonamides), APIs for the treatment of skin diseases such as psoriasis (fumarates), and products in order to counteract bone loss (bisphosphonates).

The business unit Ofichem B.V. distributes a wide range of raw materials for veterinary medicines. The business unit Ofipharma B.V. sources , packages, analyzes and distributes high quality pharmaceutical raw materials for human medicine.

If you are interested in the vacancy, please send your CV and motivation letter by email only to: recruitment@ofichem.com.

Acquisition in response to this advertisement is not appreciated

Job requirements

  • HBO / WO degree in (Bio) Chemistry, Pharmacy , Life Sciences ;
  • Experience as RA Officer is an advantage;
  • Experience in a GMP environment; experience with FDA is also preferred;
  • Correct language skills of both the Dutch and English language in word and writing.

Organizational Competences:

Integrity, Commitment, Accuracy , Pro-active, Quality Oriented

Function-related competences:

Communication, computer skills , coordination of activities, takes initiative, network skills , solution-oriented, collaboration, able to work independently

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Curriculum Vitae
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