Biotech and Agricultural Medical and Healthcare Other Science and Tech
3 - 5 Years
Regulatory Affairs Manager
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 strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
Are you a Regulatory Affairs Manager ? Do you have some development experience in gene therapy and clinical trial regulatory management, extensive experience in post- approval and life cycle management (LFC), working with Regulatory agencies as well as local Operating companies, Clinical Trial Applications (CTA’s) and Marketing authorization applications (MMA) within the EMEA region?
Advising the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
Developing an understanding of the regional regulatory environment, competitor intelligence and therapeutic area
Acting as back-up for contact, drafting cover letters and assisting in the preparation for meetings with RA.
Liaise with LOCs, track and respond to queries in a timely manner
Assist in development and improving processes related to regulatory submissions
Drafting and reviewing document content (depending on level of regulatory knowledge / expertise)
Providing input to documentation to ensure they accurately answer posted questions.
Track dates of submissions and Regulatory Agency responses
Reviewing protocols and ensure alignment with regulatory requirements
Advising the team on team submission strategies in preparation of CTAs and ensuring completion of submission packages within agreed timelines.
Reviewing improving and approving clinical trial supply plans
Provide regulatory support throughout registration process, and lifecycle management
Assisting with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
Assisting with submission and acceptance of MAA
Ensuring country-specific submission packages are made available to the LOCs in accordance with agreed plans
ESSENTIAL EXPERIENCE SKILLS AND EDUCATION:
- You have University degree in related field (Medical, Paramedical, Scientific)
- 5 year + experience in Regulatory Affairs
- You have proven experience in managing a team within Regulatory Affairs
- You are a keen Project manager with extensive experience
- You have experience of submitting CTA’s.
- You have a background in providing regulatory support through the MMA Registration process and through lifecycle management.
- You have are a committed regulatory professional with a keen eye for detail
- You are an excellent communicator and with phenomenal interpersonal skill
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- Other Locations
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-France-Haute-de-Seine-Issy Les Moulineaux Organization
Janssen Cilag Ltd. (7360) Job Function
Regulatory Affairs Requisition ID
Open Positions from Johnson & Johnson Family of Companies