Yacht Life Sciences has a vacancy for an EMEA Regulatory Affairs Liaison (Immunology & Pulmonary Hypertension) to work for Janssen Biologics.

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.

A lot of cooperation needs to be done with the US, and there are regular early and late meetings (start 9:00 and done 18:00). Therefore, flexibility is expected.