Back to job search

EMEA Regulatory Liaison

Do you have broad regulatory experience, from Development over Clinical Trial Applications to Marketing Authorization Applications ? You are fluent in English and have strong interpersonal an communication skills ? Our global pharma client is looking for an EMEA Regulatory Liaison, this is a remote position. Triggered ? Then check out the info below and don't hesitate to apply.

Job description
Our client is looking for an EMEA Regulatory Liaison to join their Global Regulatory Affairs Department.

Responsibilities

  • Strategic and tactical input in development, post-approval and Life cycle management of small /large molecules
    • Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates
    • Drive understanding of central and national regulatory requirements
    • Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan
    • Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area
    • Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labeling
    • Ensure appropriate implementation of scientific advice / Regulatory Agency comments into development and life-cycle management plan
  • Liaison with Regulatory Agencies and Local Operating Companies
    • Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments
    • Act as primary contact with EMEA. Work through LOC and/or CRO for National Regulatory Agencies contacts, as appropriate
    • Ensure appropriate involvement and liaise with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings
  • Input in document and process development
    • Advise team on required documents and processes to support Regulatory Agency contacts and submission
    • Plan and develop briefing documents for meetings with Regulatory Agencies, including determining content and review of documents
    • Provide input to and review submission documents to ensure that they are fit for purpose and support labeling statements as appropriate
    • Define, generate and submit appropriate data-driven (regional/local) responses to Regulatory Agency questions
    • Ensure necessary regulatory activities are planned and adequately tracked in company systems
  • Clinical Trial Applications (CTA)
    • Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labeling
    • Advise team on required documents and submission strategies in preparation of CTA
    • Ensure CTA submission packages are complete and available according to agreed timelines
  • Marketing Authorization Application (MAA)
    • Provide regulatory support throughout registration process
    • Provide regulatory support throughout life-cycle management
  • Resource Planning and Management
    • Determine resource requirements for assigned projects and anticipate needs for major filings
    • Provide line management, coaching and guidance to Regulatory Professionals as appropriate

Profile
Education and experience

  • University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
  • Breadth of regulatory experience in drug development and commercialization of vaccines (e.g. experience in multiple products, multiple phases of development,)
  • Experience with EU regulatory procedures (CP, MRP, national)
  • Experience in working in project teams and/or a matrix organization

Skills

  • Negotiating and conflict handling skills
  • People management skills
  • Complex project management skills
  • Oral & written communication skills
  • Organization & multi-tasking skills

Knowledge

  • Excellent knowledge of English
  • Knowledge of the applicable therapeutic area
  • In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions

Benefits

  • A balanced salary package based on your capabilities and experience.
  • Existing right to work in Europe required.

Vacancy number : 18201