Regulatory Affairs Associate Manager

Regulatory Affairs Associate Manager

Kyowa Kirin International

Netherlands

Key Responsibilities:

  • Compliance with relevant regulatory legislation and guidelines and internal policies and procedures;
  • Planning and preparation of regulatory submissions within agreed timelines;
  • Provision of regulatory advice and support to KKI cross-functional teams, affiliates and partners;
  • Sourcing of information and preparation of responses to fulfil regulatory authority requests;
  • Acting on new safety information received, as appropriate, in a timely manner;
  • Maintenance of electronic records for all submissions and communications with regulatory authorities, together with any supporting documentation;
  • Preparation, attendance and follow up of meetings with Regulatory Agencies;
  • Mentoring of less experienced regulatory staff.

Position Requirements

  • Life science qualification, preferably with extensive experience in Regulatory Affairs gained in the pharmaceutical industry across global markets;
  • Expert regulatory knowledge;
  • Good negotiation, verbal and written communication in fluent English;
  • Analytical and problem solving skills;
  • Organisational and project management skills and attention to detail;
  • Understand and present scientific arguments;
  • Ability to apply regulatory and technical expertise in multi-disciplinary teams;
  • Ability to work independently while following company objectives, policies and procedures;
  • Identify quality requirements for the development and post-market maintenance of company products;
  • Devise regulatory plans for large projects.

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© EuroJobsites 2018

EuroJobsites is a UK 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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