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Regulatory Affairs Director – 6-9 months FTC

MarkerLondon - West CoinNegotiable

Vacancy summary

Reference: 07474

Job Type: Contract

Date Posted: 22 November 2018

  • Working for a global pharmaceutical company
  • Excellent opportunity to work for a company that truly value their employees
  • Joining a fast paced, proactive team

Regulatory Affairs Director – 6-9 months FTC

A Global Pharmaceutical company based in West London is currently looking to recruit a Regulatory Affairs Director to join their team. We are seeking talented individuals who are ready to hit the ground running on an initial 6-9-month contract and would thrive in joining this fast-paced department. 

Responsibilities include:

  • Managing the development of EU regulatory product strategy, product knowledge, regulatory requirements, coming up with the new ways to achieve regulatory approvals
  • Making sure that that EU regulatory product strategy is being developed according to the regulations
  • Responsible for maintaining the regulatory product strategy, identifying emerging issues that may impact the strategy and the business, creating the implementation plan which fits into new information and changes
  • Executing the regulatory product strategy and getting the approvals for the products with labels
  • Responsible for the preparation and content of high-quality regulatory dossiers
  • Managing the relationship with European Medicinal Agency (EMA) and National Regulatory Health Authorities within the EU
  • Making sure that all new changes in the EU regulatory guidance are included in regulatory product strategy
  • Making sure that product development program and life-cycle plans are according to the business model and strategy
  • May have global responsibility for specific projects that will expect: a knowledge of global regulatory requirement, creating Regulatory Development Plan (RDP), managing the Worldwide submission plans and responsibility for global regulatory documents such as clinical trials/marketing applications
  • Making sure that company obey Health Authority commitments
  • Organization and advisory regards Regulatory
  • Making sure that all regulatory teams are up to date with regulatory product plans, progress and operational issues and submission plans
  • Leading, managing and training the RA team members

Skills and knowledge:

  • A scientific degree (Bachelors or equivalent and above)
  • The ability to network effectively with senior stakeholders and decision makers
  • Extensive experience within EU Regulatory Affairs and EU Centralised Procedure
  • In-depth appreciation of CTD modules 1-5 but especially 3-5
  • Wide experience in Haematology/Oncology, Biologics and/or ATMP
  • Thorough understanding of drug discovery / drug development, drug manufacturing and marketing required
  • Proven strong experience within regulatory affairs showing consistent progressing in your regulatory affairs career to-date
  • Strong experience within relationship with European Health Authorities
  • Matrix management experience
  • Decision maker with leading and managing skills

Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Business in relation to this role.

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