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Regulatory Affairs Senior Lead

  • Job type: Permanent
  • Location: North Holland
  • Salary: Competitive
  • Job reference: 534160/001_1528886337
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 13/06/2018

Regulatory Affairs Senior Lead

A global biotechnology company specialising in rare diseases and orphan drugs are giving the opportunity for a Regulatory Affairs Senior Lead to join the team in Amsterdam. They operate in over 100 countries and their core therapeutic areas are Haematology, Immunology, Neuroscience and Oncology. The role will be in an external manufacturing facility to oversee the commercial, operations, and Regulatory Affairs functions are performed. You will also be responsible for the regulatory support for the company's product portfolio within the local facility and the Benelux RA Team.

This is a versatile and diverse position and your time will be separated over the following responsibilities; National Regulatory Authority Interactions (20%); Country Regulatory Affairs Product Responsibilities (20%); Product Labelling Implementation (30%); Promotional Material Review (20%); Regulatory Intelligence & Regulatory Affairs Inspection-Readiness (10%).

Responsibilities

National Regulatory Authority Interactions

  • Primary contact with the Dutch Regulatory Authorities
  • Develop professional and effective working relationship with National Health Authorities
  • Support EU and regional Regulatory Affairs Strategists in their Health Authority communications

Country Regulatory Affairs Product Responsibilities

  • Ensure for assigned products the handling of local registration activities, marketing authorization and variation submissions in close collaboration with EU RA Strategy team according to Shire EU RA operating model and local regulations.
  • Ensure regulatory affairs review and approval of promotional materials
  • Ensure appropriate RA support for local product launches

Product Labelling Implementation

  • Ensure that final product labelling complies with HA approval and Company Core Data Sheet (CCDS)
  • Provide consolidated feedback from relevant LOC functions regarding text translations to EU Regulatory Strategists & Regulatory Labelling
  • Request creation of artwork (updates) where required based on national HA approval; review all packaging artworks for assigned products (centralised, MRP and national) for consistency with the marketing and local requirements (e.g. blue box, trademark and design requirements).

Promotional Material Review

  • Issue and update the abbreviated prescribing information for promotional material in line with local requirements
  • Review promotional materials and patient support materials on Shire products according to global Shire procedure and applicable codes of practice
  • Participate in local review teams and work to local regulations / requirements/codes for the review of local promotional and non-promotional materials

Regulatory Intelligence & Regulatory Affairs Inspection-Readiness

  • Proactively monitor applicable local regulations and ensure clear communication of country regulatory requirements to LOC / Benelux functions and global RA
  • Monitor the status of competitor marketing authorisations as agreed with the local business
  • Support permanent inspection-readiness of LOC RA for assigned products in accordance with local regulations and internal standards and policies

Requirements

  • Knowledge of National and EU Pharmaceutical legislation
  • Strong scientific background
  • Strong written and verbal English communication skills
  • Exhibits leadership capabilities
  • Works under general direction in line with international strategic objectors

Package

  • Salary ranging between €70,000 - €80,000, depending on candidate experience
  • 5-10% KPI Bonus

Apply:

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact Matthew Lancaster or phone +44203758831

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