Regulatory Affairs Director, International - United Kingdom
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- Our company is an exciting new biopharmaceutical company, with Headquarters in the US.
- We plan to be the credible partner in progressive, non-viral Liver Diseases to physicians, patients, payers and the broader scientific community.
- As company develops towards commercialization in 2017, we are creating a European organization full of people who are committed to bringing new innovation in Liver Diseases.
- As part of our continued growth, we have a new opportunity for a Regulatory Affairs Director, International to join our International headquarters in London.
- This position will oversee the development and implementation of sound regulatory strategies for multiple products/indications across multiple territories within the International Region, including the preparation of submission-relevant documents relating to company’s development activities
- Develop and implement sound national and international regulatory strategies for multiple products/indications.
- Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.
- Write paper and electronic submissions, as applicable, to support development project plans and timelines for IND, NDA, and MAA and related submissions, as well as amendments and supplements to these applications and
- responses to regulatory agency requests.
- Collaborate with responsible departments and leads preparation, review, and collection of documentation for regulatory submissions.
- Provide critical review of all documentation supporting regulatory applications.
- Oversee, manage and co-ordinate the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements.
- Work with peers to develop standard operating procedures and departmental guidelines.
- Participate as a full member of relevant R&D and Commercial team(s) for the company’s products.
- 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.
- Review and approve protocols, reports, and documents used in regulatory submissions.
- Assume other relevant assignments as directed by supervisor
- Bachelor’s degree in a Life Science, advanced degree preferred
- Extensive Regulatory Affairs Leadership experience of working within the Pharma Industry (pharma, biotech, CRO).
- Strong verbal and written communication skills are essential.
- Excellent organization and multi-tasking skills.
- Exceptional interpersonal skills and problem solving capabilities.
- Proven negotiation skills.
- 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.
- Being a part of building our company’s International organization from the outset is a unique opportunity.
- This role will, however, demand an ability to work strategically and operationally in equal measures.
- The position provides high visibility and growth opportunities for talented individuals who would like to accelerate themselves in a growing organization.