Norgine BV

Regulatory Affairs Executive - Amsterdam

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Nederlands

Vacature

Plaatsingsdatum 01-08-2018 Functiecategorie Farmacie
Standplaats Amsterdam Niveau Professional
Opleidingsniveau WO / PhD Dienstverband Vast contract - Bepaalde tijd m...
Uren 39 Salaris -
Regulatory Affairs Executive
Reporting to; Regulatory Affairs Manager Benelux
Location; Norgine B.V. Amsterdam
Tenure; Fulltime


MAIN PURPOSE:
The Regulatory Affairs Executive is responsible, for ensuring/preparing high quality documentation for straightforward regulatory submissions; liaising with relevant departments to ensure regulatory requirements for these submissions are met; communicating with regulatory authorities in order to expedite approval of these submissions with guidance or assistance as required.


KEY RESPONSIBILITIES & ACCOUNTABILITIES:

  • To prepare/ensure and submit, high quality documentation for straightforward regulatory submissions, following current best practice standards;
  • To liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met and to communicate with regulatory authorities in order to expedite approval of submissions, both independently and as directed by line manager;
  • To maintain and approve, product labelling for The Netherlands in cooperation with European regulatory and commercial contacts
  • To resolve straightforward regulatory issues and to assist in the resolution of more complex issues under supervision;
  • To participate as appropriate in project teams;
  • To participate in Change Control Procedures (Trackwise)
  • To prepare draft plans for submissions with agreed timelines;
  • To identify and provide information for incorporation in the Regulatory databases as appropriate;
  • To provide information on expenditure against budget for inclusion in periodic financial reports;
  • To maintain the paper and electronic filing systems (Veeva) for assigned products/countries, following Records Retention procedures.


SKILLS & KNOWLEDGE

  • Degree in a relevant life science subject or equivalent
  • Ability to communicate clearly in English
  • A fluent level of Dutch language is essential for the role
  • At least 3 years of regulatory experience or experience in the pharmaceutical industry and general knowledge of worldwide regulatory requirements (including GMP, GLP and GCP)
  • A good understanding of the drug development process
  • Awareness, understanding and an ability to interpret the ICH guidelines relevant to his/her technical/functional responsibilities, specifically for the those related to developing a Target Product Profile and delivering a product at the end of the development process
  • Demonstrates a good ability to analyse data
  • Focuses on customer needs, follows up on commitments and requests
  • Good interpersonal skills
  • Excellent verbal and written communication skills
  • Works cooperatively within a team
  • Experience with current MS Office and regulatory IT applications

Interested? Please provide us with your resume and motivation letter.
Meer informatie
Deze vacature betreft een fulltime functie.

Functiecategorie(ën) Farmacie
Branch(es) Farmaceutisch
Provincie(s) Nederland
Trefwoorden

Contactgegevens

Contactpersoon Erwin Linger

Vestigingsplaats

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