Senior Director, Regulatory Affairs
Company: Intercept Pharmaceuticals
Position: Senior Director, Regulatory Affairs
Location: San Diego, CA
Posted: May 2, 2020
Job Type: Full Time/Exempt
Contact Name: Jackie Jones
Phone: prefer not to list
Oversee development and implementation of sound regulatory strategies for multiple products 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.
- 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, NOA, 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 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 the research and development 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.
- Mentor regulatory associates and managers.
- Assume other relevant assignments as directed by supervisor
- Bachelor's degree in Biology, Chemistry or life sciences, advanced degree preferred
- 10+ years of industry knowledge experience (pharma, biotech, CRO). Experience across different sized organizations (such as both biotechnology and pharmaceutical companies) is preferable
- 10+ years of regulatory experience.
REQUIRED KNOWLEDGE AND ABILITIES:
- 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.
- Strong verbal and written communications skills
- 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; Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
- Ability to have fun!