TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.
The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark is building a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.
TrialSpark recently raised their Series C, and is putting the capital to work by in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.
About the Position
The Global Regulatory Lead is responsible for developing and directing the regional regulatory strategy, objectives, policies, and programs pertaining to developing and marketing TrialSpark’s late-stage assets. This role includes the lead regulatory responsibility for support of global registration and life cycle support and the leadership of regulatory strategy for projects that potentially will extend globally (United States and EU), coordinating departmental and cross-functional support.
- Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations.
- Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identifies and assesses regulatory risks associated with product development for TrialSpark’s drug assets.
- Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
- Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
- Provides guidance to all appropriate departments in TrialSpark to assure compliance with applicable regulations.
- Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel.
- Makes recommendations for regulatory department operating procedures.
- Actively trains/mentors’ junior staff; provides broader guidance on regulatory interpretation to TrialSpark’s staff.
- Consistently works with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, identifies and evaluates fundamental issues providing strategy and directions for major functional areas. Requires in-depth knowledge of the functional area, business strategies, and the company’s goals.
- BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent relevant experience.
- Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical industry in other areas. The regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as US and EU) to ensure appropriate leadership
- Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the HA(s).
- Ability to read, analyze and interpret scientific and technical information and regulatory documents.
- Ability to present complex issues in oral and written form
- Experienced in responding to inquiries from HAs. (EMA & FDA)
- Extensive experience with biologics and/or small molecule
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.