Regulatory UK Liaison
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Hobson Prior are currently in search for a Regulatory UK Liaison to join a global biopharma organisation who are focused on changing the lives of patients living with severe diseases. This is an exciting opportunity to be responsible for UK-specific regulatory oversight on marketed and investigational biologic and NCE products at the organisation.
Development of Regulatory Strategies For the UK
- To evaluate relevant UK regulations and guidelines and the BREXIT process critically for their impact on new drug development activities/marketed products and advise the company appropriately.
- Develop and implement sound local regulatory strategies to support assigned development projects and the approved portfolio.
- Monitor the MHRA and advise department and company as appropriate
- You will provide timely local risk/benefit analyses of local issues affecting company's investigational/development/approved products/projects.
- Develop and advise on local contingency plans for assigned investigational/development projects.
- Work with the EU lead and GRL to manage the ongoing regulatory compliance for the organisation's UK products
Implementation of Plans/Compliance for the EU region
- Accountable to support the Global Regulatory Leader and/or EU lead for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant company procedures and regional/local country regulations.
- Communicate proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice.
- Lead the planning, preparation and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.
- Recognise potential regulatory risks to the operational plan and propose options to mitigate risks.
- Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents.
- Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL and/or EU lead.
- Maintain awareness of competitors' activities and share potential impact these activities may have on the product development program.
- Delivers project assignments supporting the business e.g. representation on functional workstreams.
- To ensure that appropriate, up-to-date records are maintained for compliance.
- Any other assigned duties.
- At least 5 years of Regulatory Affairs experience within biotech/pharma industry with a preference for a successful track record in biologic and pharmaceutical product submissions.
- In-depth knowledge of the drug development, CTA, product registration processes and the MHRA.
- Demonstrated experience preparing chemistry, preclinical and clinical CTA submissions.
- Proven ability in project leadership and representing the company in formal meetings including presentations to and negotiations ideally with the MHRA.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.