Head of Regulatory Affairs EMEA

Head of Regulatory Affairs EMEA

Kyowa Kirin International

Marlow, United Kingdom

To provide leadership, strategic planning and resource management for the EMEA Regulatory Affairs (RA) organisation with the objective of ensuring that all Kyowa Kirin’s development and post-marketing regulatory activities comply with applicable legislation and aligned with company goals.

Key Responsibilities:

  • Ensure that RA activities are planned to comply with the relevant legislation and guidelines in respective territories.
  • Oversee the development and maintenance of Project and Product Regulatory Strategy in alignment with commercial and company strategy. Ensure communication to executive leadership, regional and global cross-functional teams to allow informed strategic decision making.
  • Oversee regulatory submissions process to ensure that high quality Marketing Authorisation Applications (MAA’s), Clinical Trial Applications (CTA’s) and responses to questions are prepared and submitted in accordance with Company objectives.
  • Oversee license maintenance activities to ensure that high quality submissions, such as renewals, annual updates, variations, etc, are produced and submitted, according to required timelines.
  • Ensure that regulatory submissions are reviewed and approved in accordance with relevant governance prior to submission.
  • Lead creation and maintenance of company policies, SOPs/ best practices to ensure compliance with current regulations.
  • Ensure selection and management of contractor resource, and monitoring of compliance of this resource, is carried out in accordance with Kyowa Kirin Core Policies and SOP’s.
  • Ensure that all changes under the company Change Control system that impact upon registered details of products are approved by Regulatory Department before implementation.
  • Ensure relevant company departments and licensing partners are kept up to date regarding relevant product regulatory status and information, including labelling.
  • Provide Regulatory support to current and future business partners and provide timely and effective support of due diligence activities to meet company goals for in-licensing/ out-licensing.
  • Accountable for activities associated with regulatory agency contacts including management and representation at meetings with regulatory agencies. Responsible for developing and maintaining an effective and collaborative relationship with competent authorities in the EMEA region.
  • Ensure Regulatory Affairs input into the review of promotional materials where necessary.
  • Accountable for recruiting, training, mentoring and reviewing performance of RA staff. Ensure all records of training are maintained according to company procedures.
  • Accountable to create the overall EMEA Regulatory action, budget and resourcing plans and support creation of global plans in consultation with Head of Global RA.

Key requirements include:

  • Life science qualification preferably with higher degree.
  • Extensive experience of global regulatory affairs in a pharmaceutical R&D and/or commercial environment.
  • Expert regulatory knowledge.
  • Capable of managing staff.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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