Closing Date: 11 Dec 16
Type: Full Time
Salary (£): On Application
> We have an opportunity for a Senior Regulatory Labelling Manager to join our highly motivated team. Working within the Regulatory function you shall report into the Regulatory Labelling Site Head. As a Senior Regulatory Labelling Manager you will be responsible for managing the development and maintenance of Roche Core Data Sheets (CDS) and associated product information documents. ...
We have an opportunity for a Senior Regulatory Labelling Manager to join our highly motivated team. Working within the Regulatory function you shall report into the Regulatory Labelling Site Head.
As a Senior Regulatory Labelling Manager you will be responsible for managing the development and maintenance of Roche Core Data Sheets (CDS) and associated product information documents.
• Provides strategic labelling support to teams and generate labelling scenarios for products throughout their development and maintenance lifecycle
• Take the lead and responsibility for complex CDS maintenance and development activities including the planning, creation of timelines and project management for CDS activities.
• Provide support for other CDS-related activities and initiatives as required.
• Support the implementation of CDS changes into the Local Product Labels (LPLs) and have involvement in tracking local label compliance and local label deviations.
• Support the review process for Product Label changes received from outside Roche (eg from Health Authorities).
• Networks and shares best practices within and across functions to ensure efficiency and consistency across teams
• Provide competitive labelling comparisons as required for CDS preparation.
• Support the Labelling Management team in the training of Program and Product teams on CDS policies and procedures.
• Maintain an overview of relevant global regulatory labelling requirements
Who you areYou’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
To be successful in this role, you will have/be:
• A B.Sc. in a life-science subject or in a closely related discipline and solid
experience/expertise in regulatory affairs (preferably labelling).
• Experience of developing new core data sheets for new molecular entities.
• An excellent teamworker with well-developed interpersonal skills.
• An accomplished communicator with excellent written and verbal communication skills.
• Able to successfully plan and organise your own workload.
• Committed to producing high quality outputs and demonstrate excellent attention to detail.
• Able to use Microsoft Office.
If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you. In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression.
To be considered for this position, please apply using the link below.
When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.
Closing date is 28th November 2016.
Who we areOur UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.
UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
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