Regulatory Disclosures Manager
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Zest Scientific is looking to identify an experienced Medical Writing, Biostatistics or Regulatory professional for a leading Pharmaceutical organisation in Hertfordshire.
The Regulatory Disclosures Manager will be responsible for performing the coordination and preparation of document packages for health authority submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of the company as well as internal audits and inspections.
Responsibilities of the role:
- Ensure that you compile all materials required in submissions, license renewal and annual registrations.
- Recommending changes for labelling, manufacturing, marketing and clinical protocol for compliance.
- Monitoring and improving tracking/control systems.
- Keeping abreast of health authority procedures and changes.
- Direct interaction with health authority agencies on defined matters.
- Recommending strategies for earliest possible approvals of clinical trials applications.
- You will operate across teams to provide expert health authority guidance, perfectly placed to influence and inform on matters relating to data sharing and health authority requirements regarding transparency.
- Responsible for overseeing timely and accurate protocol and results postings to health authority websites, and providing anonymised clinical documentation to external requestors, you’ll have to maintain an impressive and useful knowledge of internal and external developments affecting the business, identifying the trends and health authority changes most likely to affect business operations and data sharing strategy, and taking action.
- Supporting projects and teams with carefully designed processes and resources, you’ll need to bring a clear vision for how health authority requirements can be translated into real world deliverables.
- Identifying the required policies, tracking clinical documentation and collaborating with teams on requirements for submissions, you’ll create and maintain a working model that supports the development process in achieving the highest standards when it comes to implementing data sharing policy.
If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then our client is the organisation for you. They will provide all the support you need to further your career here in ways you might never have considered. Best of all, you’re going to work with some of the most inspiring and friendliest people you could hope to meet.