Senior Regulatory Labeling Manager
- Experience Level
Senior Regulatory Labelling Manager
Home or office based in UK/US
PRA has been contributing to the battle against COVID since day 1 and whilst there is no
doubt that we are currently working in unprecedented times, PRA has been great at creating
a sense of unity amongst our employees and globally. Our Leadership have remained
dedicated to ensuring that our employees supported and productive so if you join PRA you
can expect increased technology and IT support for all global home-workers as well as access
to extensive health & wellbeing resources.
As a Senior Regulatory Labelling Manager, you will support the wider Global Labelling Strategy team and work cross-functionally to ensure client deliverables are met.
Key responsibilities will include:
- Provide strategic labelling guidance and oversight of end to end global labelling activities
- Develop labelling content in accordance with local regulatory requirements to support regional regulatory filings
- Provide strategic interpretations of labelling regulations and guidelines in the US, EU, Japan and other international markets
- Create and maintain compliant and competitive company Core Data Sheets
- Create labelling for innovative drug-device combination products
- Lead Labelling Working groups to propose changes to labelling documents and manage/document decision making process and supporting documents
- Plan and prepare for strategic labelling negotiations with Health Authorities during labelling reviews and negotiations
- Collaborate with stakeholders and Advise on data and evidence to support labelling claims
- Manage creation and maintenance of high quality labelling documents in accordance with local requirements, incl. EU QRD template/US formatting (SRPI and 508 compliance)/Country specific labelling templates for EU/US/Japan product information/SPL and other regional requirements
- Liaise and collaborate with Labelling Operations, Packaging Operations and Supply Chain to obtain submission mock-ups/artwork/specimens for local submission
- Support Labelling-related initiatives incl. continuous improvement of processes and staying up to date on regulatory requirements
- Ensure that Labelling compliance tracking is accurate and up to date
A strong communicator and able to proactively navigate change. Someone who can lead and energize a team.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- Degree in health or life sciences or similar
- 10 years or more of relevant experience
- Previous experience working in labelling is essential
- Previous experience working with drug/device combination products is desirable
- Regulatory Affairs experience required
- Fluency in written and spoken English
- Knowledge of the scientific principles of the drug development process
- Knowledge of regulations pertaining to drug product labelling
- Excellent oral and written communication skills
- Good project management skills
- Effective critical thinking skills
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
For more information please visit our website: www.prahs.com
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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