Johnson & Johnson Careers

Regulatory Affairs Manager

High Wycombe, United Kingdom
Regulatory Affairs


Job Description

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.  

Role Purpose

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.

 

 

Key activities

 

  • •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

  • and patients

  • •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

  • to CVT.

  • •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.


Qualifications

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

Primary Location
United Kingdom-England-High Wycombe-
Organization
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Affairs
Requisition ID
1905744352W