Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

Johnson & Johnson

EMEA Regulatory Affairs Liaison (Immunology & Pulmonary Hypertension)

Posted Jan 19, 2022
Job ID: JJJP00002222
Beerse, Antwerpen, Remote
(Feb 22, 2022 - Feb 28, 2023)
40 hrs/week
Payrate range

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a EMEA Regulatory Affairs Liaison (Immunology & Pulmonary Hypertension) to join our growing team.


Main Responsibilities:  

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.
  • Determine timing and strategy for Regulatory Agency meetings and scientific advice.
  • Prepare team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies. 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 country-specific submission packages are made available to the LOCs.



Job Requirements:

Education and experience:

  • University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience .
  • Broad 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).
  • Experience in working in project teams and/or a matrix organization.
  • Previous Pulmonary Hypertension and Immunology experience preferred.



  • 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.




  • For this position you can be located in Belgium or the Netherlands.
  • Flexible working hours.
  • You will work remotely in a diverse team.
  • This is a contracting position, with the possibility of an extension after the end date. You will receive a contract via our partner Randstad Professionals in Belgium or Yacht in the Netherlands. They can offer you a employment contract or a freelance contract (ZZP). 

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