TP Therapeutics is seeking an Associate Director/Director, Regulatory CMC, who will report directly to the Vice President, CMC Operations. The Associate Director/Director, Regulatory CMC will be responsible for working in a fast growing, highly dynamic biotechnology environment, closely interacting with our in-house Regulatory Group, CMC Operations and Quality teams as well as contract manufacturing organizations, external experts and strategic partners. The incumbent will serve to provide a strong Regulatory leadership perspective in support of developing innovative CMC regulatory strategies for small molecule drug products in current and future clinical development. The position will also be responsible for hands on management of the collaborative preparation and submission of high‑quality CMC sections of INDs, IMPDs, and NDA.
- Develop and implement regulatory strategies for development projects to achieve optimal submission/approval results and ensure regulatory compliance including filing of all appropriate regulatory submissions for assigned programs.
- Coordinate all aspects of regulatory CMC submissions relevant to assigned projects or programs.
- Communicate CMC regulatory strategy, key issues and remediation activities needed throughout the project/product lifecycle, to project teams and appropriate management levels within and outside of CMC operations.
- Influence and negotiate within cross-functional teams to ensure quality submission planning and decision-making.
- Identify and assess regulatory risks associated with product development for assigned programs.
- Assist in defining strategies to mitigate risks.
- Guide the organization and preparation of high-quality submissions to ensure strategic direction and regulatory compliance with the current Guidelines and Regulations are met.
- Collect documentation from other line functions to support submission preparation.
- Perform CMC document management tasks including file transfer, storage, tracking, and archival of Regulatory CMC submission documentation to ensure databases are maintained to compliance by collaborating with regulatory affairs and regulatory operations function.
- Responsible for leading Agency meetings related to CMC sections.
- Monitor and analyze appropriate regulatory agency activities in areas of interest to the company.
- Degree in a life science discipline (e.g. Chemistry, Pharmaceutics, Biochemistry, Biotechnology, Biology) or equivalent.
- 5+ years in regulatory CMC in biopharmaceuticals preferred.
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
- Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
- Knowledge/experience of regulations, guidelines for NCEs and product lifecycle maintenance desirable.
- Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
- Effective planning, organizational and interpersonal skills.
- Reasonable approach to risk assessment.
- Excellent written/spoken communication and negotiation skills.
- Computer literacy.
EEO & Employment Eligibility
TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.
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