Associate Director Regulatory Affairs

  • Freelance
  • Fulltime
  • Tijdelijk
  • Leiden, Nederland
  • Referentienummer: DT/20-059-DD

Derks & Derks Detachering

Temporary position for 6 months at a pharmaceutical company

Offer

  • a diverse job at a global pharmaceutical company
  • an interesting job because of the international contacts
  • a temporary contract for 6 months, with the possibility to extend

Organisation

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has tight lines all around the world. The organisation is looking for a highly experienced Associate Director Regulatory Affairs Manager.

Position

As an Associate Director Regulatory Affairs you will be responsible to ensure strategic and operational alignment of RA activities with other functional departments in AP-MENA/SSA and ensure adequate planning and resources to adhere to the targets defined in the Business (Review) Meetings. You will make sure that Regulatory Affairs Managers in AP-MENA/SSA prepare (tailoring for local submission), dispatch to agents and business partners and ensure submission to local authorities and maintain as directed by RAE. You will make sure that Marketing Authorization Applications (MAA) are made according to current legislation, in order to obtain and maintain marketing authorizations in the geographical business area of AP MENA/SSA. This is directly linked to the strategic business obligations of the affiliate to the European objective. You will support the Regulatory Affairs and Quality Director in overall quality improvement and assurance and management of the regulatory group. Together with the Manager you will also have specific regional and product responsibilities and tasks (RAM responsibility). In this position you will work in a small team and report to the director of RA of the MENA/SSA.

Profile

  • Master degree in pharmacy, chemistry of (medical) Biology preferred
  • at least 5 years‘ experience with international RA activities in the pharmaceutical industry
  • preferable additional team leader or project leader experience
  • experience in working in multidisciplinary teams
  • ability to work with well-organized project management, result oriented and working under pressure
  • excellent communication and writing skills (advise, convince, negotiate, listen, coach, present and edit)
  • coaching skills and capability to lead an experts team, with experts working at various levels & experience
  • relatively high abstraction level, to be able to switch to required levels and stand-points
  • ability to generate a realistic work-planning, derived from a vast number of data and information
  • good communication skills (positive & constructive attitude, desire and ability to work in multidisciplinary / international teams)
  • good knowledge of the regulatory rules, guidance and institutes in MENA/SSA territory
  • adequate knowledge to work with information technology systems (e.g. Windows, MS Office and Dbases)
  • Fluent in English language, both spoken and written

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-059-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Is this not the job you are looking for? Please visit www.derksenderks.nl/nl/nieuwe-baan/vacatures for other challenging positions in pharma, food and medical.

Tagged as: Life Sciences

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