Associate Director Regulatory Affairs (Neuroscience/CVM) - Janssen Pharmaceuticals - Beerse
Johnson & Johnson Family of Companies
Région
Beerse
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
Qualifications
Job Requirements
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 (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 Neuroscience/CVM experience preferred
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
Primary Location
United Kingdom-England-High Wycombe-
Other Locations
Netherlands-South Holland-Leiden, Belgium-Antwerp-Beerse
Organization
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Affairs
Requisition ID
00001GF9