Johnson & Johnson Careers
Associate Director EMRL
High Wycombe, United Kingdom
Requisition ID: 1805681004W
The Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science.
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 single day, in more than 150 countries, we bring ground breaking science and the most creative minds in the industry together to think differently about diseases. We seek 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
Due to internal promotion we are looking for a EMEA Regulatory Liaison to join our team, you will hold responsible for aspects of strategic and tactical input in development, post-approval and Life cycle management, Liaison with Regulatory Agencies (RA) and Local Operating Companies, Input in document and process development and Clinical Trial Applications (CTA).
•Advising the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates
•Developing and ensuring effective implementation of regional regulatory strategy and tactics in support of the global development and life-cycle management (LCM) plan
•Developing a keen understanding of the regional regulatory environment, competitor intelligence and therapeutic area
•Providing input for developing and updating the Target EU SmPC based on your knowledge of the implications of regulatory strategy for labeling
•Ensuring appropriate implementation of scientific advice / Regulatory Agency comments into development and LCM plan
•Establishing and maintaining positive relationships with RA and effectively negotiate on product-specific labeling, study design, submissions content, and post-approval commitments
•You will act as primary contact with EMEA. Work through LOC and/or CRO for National Regulatory Agencies contacts, as appropriate
•Ensuring appropriate involvement and liaise with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings
•Planning and developing briefing documents for meetings with RA, including determining content and review of documents
•Providing input to and review submission documents so that you ensure that they are fit for purpose and support labeling statements as appropriate
•Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labeling
•You can advise the team on required documents and submission strategies in preparation of CTA and ensuring CTA submission packages are complete and available according to agreed timelines
•You will be responsible for providing regulatory support throughout registration process and LCM
Required skills, Knowledge and Education:
•Do you have either a University degree in a medical or paramedical (pharmacy, biology, veterinary etc.)? or equivalent by experience?
•You have a breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)
•Does your experience include EU regulatory procedures (CP, MRP, national)?
•You are experienced in working in project teams and/or a matrix organization, with Negotiating and conflict handling skills
•You have excellent people management and interpersonal skills
•Ideally you will have experience working in the Oncology therapeutic area
Does this sound like the opportunity for you? If so please click to apply.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)