Johnson & Johnson Careers
Associate Director EMEA RA
Requisition ID: 1805691654W
Who are 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. 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.
We are looking 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 we are striving to provide access to effective and affordable medicines and related healthcare services to the people who need them.
We have an opening for an Associate Director for EMEA Regulatory affairs lead to join our team. You will have extensive experience as a Senior Regulatory manager or Associate director in clinical development in Oncology. You will be filling products in the EU centralised procedures playing a core operational role with our oncology products.
- You will be providing regulatory advice on issues to the project team or reginal therapeutic area leader.
- Developing effective implementation of reginal regulatory strategy and tactics to support global development and lifecycle management plans.
- Continuously developing your understanding of the regulatory environment and competitor intelligence within your therapeutic area.
- Acting as a primary contact with EMEA you will be working through LOC and/or CRO for National Regulatory Agencies contacts.
- Determining timing and strategy for Regulatory Agency meetings and scientific advice you will prepare your team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies (RA's).
- Plan and develop briefing documents for your scheduled meetings with RA's, including determining content and review of documents
- Providing input and reviewing submission documents while you ensure that they are fit for purpose, supporting labeling statements as appropriate
- Ensuring Clinical Trial Applications protocols are developed and align with regional strategies, while ensuring submission packages are complete within agreed timelines.
- Providing Regulatory support throughout registration process and Life-cycle management, Market Authorization applications.
- Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate)
- Provide line management, mentoring and guidance to Regulatory Professionals
Do you have the following background, skills and education?
- Did you study ad BSc level or above in a specific or medical University degree ?
- Do you have regulatory experience in drug development and commercialization?
- Experience with EU regulatory procedures (CP, MRP, national), within project teams and/or a matrix organization
- Excellent soft skills in Negotiating, conflict handling and people management.
- Extensive experience in the Oncology therapeutic area
- Leading regulatory projects with an in depth knowledge of regulatory affairs, guidelines and practice of EMEA regions
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)