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Regulatory CMC Lead

Employer
TrialSpark
Location
New York, NY; Open to Remote
Start date
Sep 18, 2022

View more

Discipline
Regulatory, Regulatory Affairs, Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

About TrialSpark

TrialSpark is a technology-driven drug development company focused on bringing new treatments to patients faster and more efficiently.

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.

The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the registrational trials may take nearly a decade and frequently costs $1B+. To address  this industry problem, TrialSpark has built a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.  Along with the focus on clinical trials, we are building an R&D team develop the licensed products and look for additional ways to make the drug development process faster and more efficient.

About the Position

The Regulatory CMC Lead is a critically needed leader in the TrialSpark regulatory team and is responsible for defining the regulatory component of   the CMC strategy defined for the company by the CMC and R&D leadership team.  In addition, they will be responsible for  planning and the preparation of global CMC regulatory submissions to achieve timely approvals for TrialSpark’s late-stage drug assets.  In addition, they will be responsible for maintaining regulatory CMC compliance once the drugs are approved.  Responsibilities include actively developing and implementing CMC regulatory strategy for TrialSark’s designated therapeutic areas, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading CMC Health Authority interactions, and providing regulatory CMC leadership to cross-functional program teams.  This position reports directly to the VP, Regulatory affairs and is a key member of the regulatory leadership team at Trialspark. Additionally, they are an integral member of the CMC team.

Responsibilities

  • In close collaboration with the Regulatory Affairs and CMC leadership teams, will be accountable for setting an innovative global CMC regulatory strategy across products that meets the business missions and objectives while meeting regulatory requirements .
  • Identifies supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines, particularly when these deliverables are from CDMO’s.
  • Accountable for strategy, planning, definition of content, preparation, review and approval of global regulatory CMC submissions and responses to Health Authority questions.
  • Accountable for review and approval of CMC submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.
  • Leads cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products.
  • Highlights and proactively communicates anticipated and ongoing critical Regulatory CMC issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate
  • Accountable for all regulatory CMC related interactions, resolution of CMC issues and negotiation of CMC approvals with HAs in all regions. (US & EU)
  • Establishes and maintains modes of effective communication and collaboration with the teams assigned projects/products.
  • Accountable for the coordination and overall global approval of regulatory assessments for CMC changes.
  • Defines and communicates the need for internal and/or external regulatory CMC resources to the Regulatory Affairs leadership team as required to deliver CMC submissions for assigned projects/products in all regions to the agreed timelines.

About You 

  • BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.
  • At least 7+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 5+ years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field. Deep Knowledge of global guidance, regulations and ICH/GMP requirements expected.
  • Demonstrated ability to set CMC regulatory strategy and lead a team of colleagues to execute the strategy.
  • Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities
  • Broad background of registration experience (eg small molecules and biologics)  gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions highly desired.
  • Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics
  • Execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities. 
  • Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure, particularly with the CMC and quality teams
  • Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.

 

We offer an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.

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.

Company

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.

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.

Find Us
Website
Phone
+1 510-545-3803
Location
16 East 34th Street floor 10
New York
NY
10016
United States
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