Manager, Regulatory Compliance – Belgium

Excelya>Full-time>Manager, Regulatory Compliance – Belgium

Job description

For one of our clients, we are looking for a Manager Regulatory Compliance

Reports to: 

EMEA Regional Therapeutic Area Leader

Job Description

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

Qualifications and Skills: 

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

• 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



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