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
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.