Johnson & Johnson Careers
Regulatory Affairs Manager
Requisition ID: 1905744352W
Regulatory Affairs Manager:
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.co.uk for more information.
We are looking for a Regulatory Affairs Manager to ensure the Management of processes to ensure compliance with regulatory requirements and an inspection ready culture. This includes:
Responsible for specific therapeutic area activities, questions & relations, including CVT
attendance as required.
Occasional therapeutic area technical and administrative activities as required.
Contribute to shaping local regulatory strategy.
May include day to day line management of direct report/s.
•Leading the adoption and implementation of new systems and processes to streamline
routine regulatory activities.
•Collaborating with, and influences cross-functional colleagues to ensure efficiency
gains and to support business continuity.
On occasion you will also include the occasional need to deputise for Head of RA with
Provide Regulatory support for a portfolio of promoted and non-promoted products
•Preparing and submits regulatory documentation as required.
•Monitoring deadlines for different cross-team projects to ensure they are met or
escalated to Head of RA.
•You will be responsible for the content of the local labelling documents released to prescribers
•Preparing and distributes local labelling documents within stipulated timelines following
receipt of relevant approvals from RRR.
•Preparing for and manages local procedures following the EMEA Regulatory Affairs
strategic plan, assuring timely execution and compliance and explaining RA strategy
•Implementing Risk Management Plans and when required co-ordinates of cross
functional team to implement/update Risk Management Educational Material.
•Ensuring compliance with all regulatory requirements for self and team
•Developing and maintaining in depth knowledge of regulations/legislation
•You will be up-to-date with and adapt early to local changes in the regulatory environment
•Supporting EMEA with collection of RA competitive intelligence as required
•Supporting and contributing to GRA-EMEA initiatives as requested by Head of RA.
•Contributing to local initiatives around lessons learnt and change management to
ensure efficiency gains.
Does this role look of interest? Please submit your application if you have the following skill, experience and education?
Over 5 years Regulatory Affairs experience at both operational and strategic level.
Strong data gathering and analytical skills.
Direct experience and strong knowledge of general regulatory requirements and guidelines.
Significant persuading/ influencing, negotiating skills.
Significant line management experience.
University Degree in Pharmacy, Biology, Chemistry or related Life Science
We respectfully request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Janssen-Cilag Ltd, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)