SRG are currently looking for Regulatory Associate for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 12 Month basis to be based at their office in Brentford.
A Regulatory Executive is responsible for the timely production of documentation, management and maintenance of Global Product Information for Prescribing/Patient/Packaging Information and assisting in the preparation of the nonclinical content for various global regulatory dossiers.
- Authoring, development and maintenance of the Global Product Information.
- Authoring of the patient information in the Global Patient Leaflet.
- Authoring, development and maintenance of the EU product information.
- Generation of responses to regulatory agency questions related to prescriber and patient information.
The development and maintenance of the Global PI, together with support of local product information requires leadership of cross-functional teams and the ability to work with individuals at all levels of the business.
This role requires prior relevant experience and may include:
- Participation in the development of Development Core Safety Information.
- Development of Global PI for Product Line Extensions, with appropriate mentoring.
- Independent management of the Global PI for marketed products, including presentation of items at Global Labelling Committees.
- Authoring the Global Patient Leaflet and Global Packaging Component of the Global PI.
- Management of the development and maintenance of EU documents through the early product lifecycle.
- Active membership of the Regulatory Matrix Team and submission writing process.
- Awareness and application of relevant pharmaceutical regulation and new guidelines/policies relevant to product information.
- Supporting Local Operating Companies during implementation of Global PI wording.
- Authoring responses to labelling questions from regulatory agencies.
- Authoring Competitive Labelling Assessments.
- Authoring relevant sections of the Periodic Safety Update Report.
- Participation in other projects and activities, such as contributing to the implementation of changes to processes within GRA Labelling.
- Life sciences degree (Pharmacy preferred) or relevant experience, or PhD or equivalent relevant experience.
- Relevant experience includes pharmacy practice, regulatory affairs, medical affairs, clinical research, or pharmacovigilance.
- Excellent Scientific Regulatory Writing.
- Data analysis.
- Therapeutic / Product Knowledge.
- Regulatory Knowledge.
- Basic understanding of policy and processes relating to management of prescriber, patient and pack information.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: email@example.com or +441615077288
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