Johnson & Johnson

Associate Director Regulatory Affairs (Oncology)

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Job Description

Associate Director Regulatory Affairs (Onco)

Reports to: EMEA Regional Therapeutic Area Leader (Oncology)

Main Responsabilities

Strategic and tactical input in development, post-approval and Life cycle management

  • 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
  • Determine timing and strategy for Regulatory Agency meetings and scientific advice
  • Prepare team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies. Define attendance in consultation with GRL and CDT. Issue minutes and contact reports and disseminate correspondence, faxes, contact reports from contacts with Regulatory Agencies
  • Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed
  • Negotiate labeling with Regulatory Agencies, going through each of the back-up strategies if necessary

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
  • Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate)
  • Ensure timely MAA availability, track critical path activities
  • Responsible for submission and acceptance of MAA
  • Ensure country-specific submission packages are made available to the LOCs

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
Job RequirementsEducation and experience
  • University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
  • Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)
  • Experience with EU regulatory procedures (CP, MRP, national)
  • Experience in working in project teams and/or a matrix organization
  • Previous Oncology experience required
  • Negotiating and conflict handling skills
  • People management skills
  • Complex project management skills
  • Oral & written communication skills
  • Organization & multi-tasking skills
  • Excellent knowledge of English
  • Knowledge of the applicable therapeutic area
  • In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions
Primary Location
United Kingdom-England-High Wycombe-50-100 Holmers Farm Way
Other Locations
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Affairs
Requisition ID

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