Regulatory Consultant - Liaison
Are you looking to establish your regulatory career?
Join a larger pharmaceutical company as a Regulatory Consultant. This is an exciting opportunity to be responsible for UK-specific regulatory oversight on marketed and investigational products. You will also need to prepare and deliver regulatory operational plans for assigned projets. You will also be expected to provide strategic guidance within cross fuctional teams and regions.
- 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
- 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 UK products
- Support the Global Regulatory Leader (GRL) 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 procedures and regional/local country regulations.
- 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.
- Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
- Identify 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
- Ensure that appropriate, up-to-date records are maintained for compliance
- Assist in development of regulatory standards and SOPs
- Provide input into Regulatory Strategy Plans and project budget as delegated by GRL
- Assist in due diligence activities for in-licensing opportunities
Skills and Requirements
- Minimum of 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.
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