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 to 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 at Janssen are striving to provide access to effective and affordable medicines and related healthcare services to the people who need them.
Due to the success of Janssen Oncology products and an expanding portfolio of innovative treatments we are looking to grow our Oncology team. We are looking for an experienced Regulatory Affairs Associate Director (Senior Manager) with extensive experience in clinical development in Oncology.
Your experience should include:
- Developing effective implementation of regional regulatory strategy and tactics to support global development and lifecycle management plans
- 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 labelling 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, Life-cycle management and Market Authorization applications
- Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs
- Providing line management, mentoring and guidance to Regulatory Professionals
- Ideally have extensive practical experience of working in the Oncology Therapeutic area.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.