Norgine BV

Regulatory Affairs Manager Benelux - Heverlee

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Job

Active since 25-07-2017 Job category Pharmacy
Location Heverlee Level Management
Educational level Master / Post-Graduate / ... Employment type Fixed term contract with option...
Hours 39 Salary -
Regulatory Affairs Manager Benelux


Reporting to; Associate Director Regulatory Affairs

Location: Heverlee (Belgium) or Amsterdam (Netherlands);

Tenure; Permanent



MAIN PURPOSE:

The Regulatory Affairs Manager plans and manages all regulatory activity associated within the business units Belgium, Luxembourg and The Netherlands (Benelux); elegible to act as local responsible for distribution of medicinal products in Norgine NV (Belgium).


KEY RESPONSIBILITIES & ACCOUNTABILITIES:

  • Responsible for planning and managing all regulatory activity associated within Benelux.
  • Manage the Regulatory Affairs team Benelux (currently 4 direct reports).
  • Responsible for storage and distribution of all products of Norgine NV (Belgium) in accordance with Good Distribution Practice (GDP). Act as a deputy responsible for GDP for Norgine BV (The Netherlands).
  • Responsible for handling complaints, quality defects and recalls for Norgine NV (Belgium).
  • Responsible for administrative release of products distributed by Norgine NV (Belgium).
  • Is a key member of the Benelux management teams emphasizing the regulatory quality and legal related interests of the business.

MAIN TASKS:

  • Manage the preparation of high quality documentation for all regulatory submissions, following current best practice standards.
  • Liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met in a compliant manner and proactively communicate with regulatory authorities in Belgium, The Netherlands and Luxembourg in order to expedite approval for submissions.
  • Manage submission strategy and plans for Belgium, The Netherlands and Luxembourg.
  • Provide introduction training to new staff.
  • Support or write applications for pricing and reimbursement.
  • Manage the regulatory affairs budget of Benelux.
  • Interact with industry trade associations.



SKILLS & KNOWLEDGE

  • Pharmacist or Physician.
  • Fluent level of Dutch, French and English language, both verbal as well as written.
  • Line management experience in a regulatory position (minimum 5 years). Works cooperatively within a team and leads a team as appropriate.
  • Exercises considerable autonomy in decision making and objective setting.
  • Excellent interpersonal and leadership skills.
  • Technical experience of Trackwise, Veeva Vault RIM and SharePoint is a plus.

Please send your application including motivation letter and resume via the Apply button on the screen.

Closing date; Monday 28 August 2017
More information
This listing is a full-time job

Job category Pharmacy
Industry / Industries Pharmaceutical
Region Netherlands
Keywords Regulatory Affairs, Registratie, Responsible Person, RP, FAGG

Contact information

Name Erwin Linger

Location

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