Director Regulatory Affairs, EU

Director Regulatory Affairs, EU

Intercept

London, United Kingdom

Job Description

CORE ACCOUNTABILITIES:

The successful candidate must be able to perform each of the following satisfactorily:

  • Develop and implement sound regulatory strategies in collaboration with US based Global Regulatory Strategy Lead and local consultants
  • Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.
  • Lead preparation, provide critical review, and ensure collection of documentation for regulatory submissions, as appropriate.
  • Write paper and electronic submissions to support regulatory submissions, as well as amendments and supplements to these applications and responses to regulatory agency requests, as required.
  • Oversee, manage and co-ordinate the regulatory collaboration with CROs or other partnering organizations to meet regulatory requirements related to new submissions or post marketing regulatory deliverables, as appropriate.
  • Participate as a full member of relevant R&D and Commercial teams.
  • Develop and manage regulatory project specific timelines, in keeping with Corporate objectives and actively participates on project teams advising on submission preparation timelines, processes, and requirements.
  • Assume other relevant assignments as directed by supervisor
    • Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team;
    • Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities;
    • Make Intercept a truly desired place to work.

Experience and Skills

QUALIFICATIONS:

  • Bachelor’s degree in a Life Science, advanced degree preferred;
  • Extensive Regulatory Affairs Leadership experience of working within the Pharma Industry (pharma, biotech, CRO);
  • Prior experience of having led (not contributed to) an EU regulatory procedure for a new drug.

REQUIRED KNOWLEDGE AND ABILITIES:

  • Scientifically competent, especially in clinical development;
  • Strong verbal and written communication skills are essential;
  • Excellent organization and multi-tasking skills;
  • Exceptional interpersonal skills and problem solving capabilities;
  • Proven negotiation skills;
  • Comfortable dealing with ambiguity and to be credible with senior leaders;
  • Ability to work effectively across a matrix organization;
  • Ability to work independently and prioritize with minimal daily instruction;
  • Ability to think strategically in order to improve current processes;
  • Learning agility and ‘scalability’ to take on increasing responsibility as Intercept grows;
  • Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity;
  • Understanding the legal and compliance environment.

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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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