Regulatory Affairs, UK liaison - 12m contract - Remote

Reference: RS050221A

Expiry Date: 05-07-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

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Job Description

Regulatory Affairs, UK liaison - 12m contract - Remote

Global Biopharma Company with a substantial pipeline of products in mid to late development as well as a respectable portfolio of marketed products is seeking a RA Uk Liaison on a 12 month contract. (Remote working).

ROLE:

There are two aspects to this role:

The first is to be responsible for UK-specific regulatory oversight on marketed and investigational biologic and NCE products. To do this the candidate should be able to advise the development teams on local strategy and procedures. In line with this the role will serve as the primary regulatory liaison between the MHRA and the Client and will provide leadership and oversight of the transition of the MHRA through BREXIT to help ensure any impact on business continuity is minimised. In addition, the role is anticipated to include liaising with a contract organisation that provides the local affiliate regulatory resource to ensure alignment.

The second aspect, as or if time allows, is to prepare and deliver regulatory operational plans for assigned projects/products within the broader EU region. Provide strategic and operational regulatory input and guidance in cross-functional teams and manage quality regulatory submissions to agreed project targets. To achieve this the candidate must be able to work flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.

Accountabilities:

  1. Development of Regulatory Strategies for the UK:
  1. 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
  2. Develop and implement sound local regulatory strategies to support assigned development projects and the approved portfolio
  3. Monitor the MHRA and advise department and company as appropriate
  4. Provide timely local risk/benefit analyses of local issues affecting company’s investigational/development/approved products/projects.
  5. Develop and advise on local contingency plans for assigned investigational/development projects.
  6. Work with the EU lead and GRL to manage the ongoing regulatory compliance for UK products.

     2. Implementation of Plans/Compliance for the EU region:

  1. 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 UCB procedures and regional/local country regulations.
  2. 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.
  3. Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
  4. Identify potential regulatory risks to the operational plan, and propose options to mitigate risks.
  5. Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
  6. Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL and/or EU lead.
  7. Maintain awareness of competitors’ activities and share potential impact these activities may have on the product development program
  8. Delivers project assignments supporting the business e.g. representation on functional workstreams
  9. Ensure that appropriate, up-to-date records are maintained for compliance
  10. Assist in development of regulatory standards and SOPs
  11. Provide input into Regulatory Strategy Plans and project budget as delegated by GRL
  12. Assist in due diligence activities for in-licensing opportunities.

EXPERIENCE:

  • 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.

Please do contact me ASAP if this sounds like you.

To Apply!

To apply for this role, please contact me, the Clinical & Medical Hiring Lead, asking for Roland Schnapka, on +44 (0)207 801 3387 or send a full CV to roland@advtalent.com. Alternatively, please press the red “Apply for position” button and follow the registration process.

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