SRG are recruiting for a Regulatory Affairs professional to work on a 6 month contract based in Kent.
SRG are recruiting on behalf of a Global Pharmaceutical Company who have opened a new vacancy and are looking to recruit a Regulatory Product Licence Support Manager on an initial 6 Month contract to be based at their offices in Kent.
Maintain compliance by delivering the portfolio of one or multiple applicable regulatory obligations.
Product License Support Group comprises coordination of regulatory compliance starting at drug development stage and reaching through the lifespan of the Product.
Once a New Drug Application is approved, a host of activities are required to set up and maintain the new drug label and essential product information (known as drug listing data) to the client's website and FDA, the National Library of Medicine Website and the Drug Registration and Listing System team. Compliance activities continue with coordination of information in support of New Drug Application Annual Reports and NDA Periodic Reports.
- Support delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, certificates and samples sourcing, XEVMPD submissions and other post market scheduled regulatory compliance activities in accordance with 21CFR 314.81
- Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g. Drug listing and Establishment registrations,
- Delivery of Product License Support Portfolio in a timely and quality manner.
- Contribute to the completion of project tasks and/or milestones
- Organise own work to meet project task deadlines Learns and applies basic team effectiveness skills (e.g., commitment, feedback, consensus management) within context of immediate Work Team.
- Use technical skills to achieve assigned regulatory operational responsibilities to support submissions to the Regulatory Authorities.
- Apply fundamental knowledge of the relevant regulatory industry and local business environment.
- Have fundamental knowledge of clinical, regulatory and/or other relative stakeholder groups.
- Provide guidance to and/or may lead/co- lead moderately complex projects
- Leverages regulatory expertise, emerging market trends and technical skills to enhance operational support and relationships.
- Responds to colleagues questions about regulatory policies and procedures and direct them to appropriate resources.
- Undergraduate degree plus relevant experience as below, or demonstrated fluency with regulatory submissions publishing and understanding of application of technologies
- Regulatory Expertise: Demonstrated knowledge of Regulatory compliance requirements, processes and systems.
- Demonstrated Project Managements Skills: Competent illustration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.
- Technology: Experience and competency with Regulatory software, XML, Document Management, regulatory milestone reporting tools.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or +441753 589673
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