This role will be responsible for developing and executing on global regulatory strategies, tactics and deliverables associated with the development of our products in order to support development objectives and achieve successful drug registration. This position is also responsible for managing existing INDs/CTAs and initiating INDs/CTAs for pipeline products, subsequent FDA filings, as well as clinical trial applications and all other documentation in accordance with U.S. and global regulatory requirements.
- Develop and implement strategies for efficient high quality regulatory correspondence, clinical trial applications, and marketing application submissions and approvals.
- Responsible for directing activities related to the regulatory development of our products from research and development through statutory requirements pertaining to registration and post-marketing.
- Provide regulatory guidance and advice to product teams and senior management to achieve goals related to drug development and commercialization, including regulatory timelines, worldwide regulatory strategy, clinical trial application requirements, and chemistry, manufacturing and controls (CMC) development
- Provide oversight of the coordination, preparation and timely submission of applications (IND, BLA, etc.), updates and amendments to domestic and international regulatory agencies.
- Provide support for and coordination of regulatory meetings and information package development.
- Liaise with and coordinate with all relevant external organizations, including contract research organizations and other vendors providing research and development services to satisfy regulatory requirements.
- Serve as a liaison with FDA and other regulatory agencies, in coordination with regional regulatory representatives (internal or CRO) on a global basis.
- Ensure company compliance with all applicable guidance, regulations and laws.
- Monitor the development of new regulatory requirements or guidances and advise product teams and senior management of the impact on the business or development programs.
- A minimum of 8 years of experience in regulatory affairs within the pharmaceutical industry.
- Proven regulatory leader with successful tactical execution experience.
- Extensive experience in the drug development and approval process including a successful track record of success in IND/CTAs and BLA/marketing applications.
- Experience with the regulatory aspects of the development of biologics, particularly in rare diseases, is preferred.
- Experience in global clinical trial application processes preferred.
- Strong global understanding of applicable guidelines and regulations pertaining to drug/biologics development.
- Advanced degree in a scientific discipline preferred.
- Strong verbal and written communication and presentation skills.
- Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams.
- Self-motivated and results-oriented with high energy drive to define and achieve objectives that support the business.
Indeed - 14 months ago
Synageva BioPharma is a publicly traded biopharmaceutical company with headquarters, research and development facilities in Lexington, MA,...