Johnson & Johnson Careers

Senior Regulatory Project Manager

High Wycombe, England
Regulatory Affairs


Job Description

Requisition ID: 1805649872W

Janssen-Cilag Ltd, pharmaceutical company of Johnson & Johnson, is recruiting for a Senior Regulatory Project Manager, located in High Wycombe, the United Kingdom.

At 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. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

We are Janssen.

Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Role Purpose

To provide regulatory support for a portfolio of promoted and non-promoted products ensuring:
- regulatory documentation is prepared in line with the current UK and Irish regulatory requirements, is of high quality and submitted to MHRA and HPRA in line with strict timelines
- MHRA and HPRA quires are addressed promptly
- product information is released to prescribers and patients line with strict timelines
Initially the role is focusing on projects with deadlines linked to the UK’s exit of the European Union in March 2019.


Key Role Activities


• Prepares and submits regulatory documentation
• Monitors deadlines for different projects to ensure they are met
• Responsible for the content of the local labelling documents released to prescribers and
patients
• Prepares and distributes local labelling documents within stipulated timelines following
receipt of relevant approvals
• Prepares for and manages local procedures following the EMEA Regulatory Affairs
strategic plan, assuring timely execution and compliance
• Partner with allocated commercial teams to provide regulatory expertise and support
• Collection of regulatory competitive intelligence as required


Qualifications
Essential Technical Knowledge, skills and experience
 
• Regulatory Affairs experience at operational level
• Direct experience and strong knowledge of UK and Irish regulatory requirements and guidelines
• Strong attention to detail and problem solving skills
• Strong data gathering and analytical skills are essential
• Strong persuading / influencing, negotiating skills are required
• University Degree in Pharmacy, Biology, Chemistry or related Life Science
• Registered member of the Organisation for Professionals in Regulatory Affairs




Primary Location
United Kingdom-England-High Wycombe
Organization
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Affairs
Requisition ID
1805649872W