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Associate Director, Regulatory Affairs EMEA
High Wycombe, United Kingdom
Requisition ID: 1805625278W
Job Title: Manager, Associate Director, Regulatory Affairs
Business: Janssen UK
Department: Global Regulatory Affairs
Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
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 labelling
• 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 region. Work through regional regulatory networks 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 Global Regulatory Leader and compound development team.
• Issue meeting 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 labelling with Regulatory Agencies.
EU Marketing Authorization Application (MAA)
• Provide oversight and regulatory leadership throughout registration process
• Provide regulatory leadership 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 where required country-specific submission packages are made available to the local operating companies
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
Clinical Trial Applications (CTA)
• Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labelling
• Advise team on required documents and submission strategies in preparation of CTA
• Ensure CTA submission packages are complete and available according to agreed timelines.
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)
• Experience with centralised EU regulatory procedures (MAA, variations, paediatric investigation plans, Orphan designation, scientific advice procedures.
• 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 oncology or haematological oncology therapeutic area, experience of biological, immunotherapy or cell based therapies would be desirable. • In depth knowledge of the regulatory environment, guidelines and practice of the European Union.
What we’re about
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each
• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Unique in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson.
United Kingdom-England-High Wycombe
Janssen Cilag Ltd. (7360)