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Regulatory Affairs Manager Benelux - Belgium, Netherlands   We are currently searching for a Regulatory Affairs Manager Benelux

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Functional titles : Regulatory Affairs Manager ,  Regulatory Affairs Consultant ,  Regulatory Project Manager ,  Regulatory Affairs Associate ,  Regulatory Affairs Assistant ,  Director Regulatory Affairs
Project Types : Permanent position ,
FTE : 100 %
Min.Experience : 3 year
Start Date : ASAP
End Date : N/A
Posted on : 05 September 2017

Project is currently here

Step 1
Application
Step 2
BrightOwl Screening
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BrightOwl Interview
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Company Screening
Step 5
Company Interview
Step 6
Budgets & Contracts
Step 7
Position filled

Project Description

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 for our company in (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.

Others

Project FTE 100%
Work from home:   Not Allowed
International Travel:   Yes
No. of Positions:   1

Personality

Adaptability Aggressiveness Analytical thinking Approachability Assertiveness Attention to detail Collaboration Communicative Competitiveness Coordination Creative thinking Critical thinking Curiosity Dependability Diligence Efficiency Flexibility Independence Individuality Innovative thinking Interest in knowledge Kindness Proactivity Perspective Problem solving Reaction to stress Responsibility Self-discipline

Knowledge

Lab scale batches Good Distribution Practice (GDP) dutch English French Regulatory submissions Regulatory Requirements Regulatory affairs Regulatory Compliance Understanding of regulatory guidelines Quality Management Quality Auditing Quality Assurance (QA) management

Skills and Expertise

pharmacist M.D english Dutch French Regulatory documentation Manage regulatory activities Writing regulatory documents Prepare regulatory documents Submit regulatory applications Interact with regulatory stakeholders Maintain Quality Management System (QMS) Manage Quality Management System (QMS) documentation Quality Management Veeva Vault RIM

Degree

Master Ph.D. Advanced Master

Languages

English
Professional Proficiency
Is a big plus
Dutch
Professional Proficiency
Is a big plus
French
Professional Proficiency
Is a big plus

Desired Skills & Experience

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.

 

Project opportunities at this company

No more opportunities available