Associate Director/Senior Manager, Regulatory CMC
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, Repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer (NSCLC) and advanced solid tumors. Turning Point Therapeutics is driven to develop therapies that mark a turning point for patients in their cancer treatment.
Turning Point Therapeutics is seeking an Associate Director/ Senior Manager of Regulatory CMC. The position is responsible for working in a fast-growing, highly dynamic biotechnology environment, closely interacting with our in-house Regulatory Group and CMC Operations and Quality teams as well as external experts and strategic partners. The position will provide regulatory support for assigned corporate development programs and is responsible for the regulatory aspects of the Chemistry Manufacturing Controls (CMC) development for small molecules. The position will participate in global CMC regulatory activities as necessary to conduct clinical trials and achieve marketing approval of drug candidates. Serves as a resource to the CMC team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through marketing application. This position will report to the Director of Regulatory CMC.
- Supports the CMC regulatory affairs activities for compounds in development in line with US, European, International Conference on Harmonization (ICH), and other applicable requirements.
- Coordinates with Regulatory, Quality Assurance, Pharmaceutical Development, and other functional areas to develop and implement CMC regulatory strategy.
- Supports the regulatory function on assigned development teams providing CMC regulatory guidance and strategy including identifying and assessing regulatory risks.
- Collecting documentation from other line functions to support submission preparation.
- Manages the timely preparation, review, and submission of documents to regulatory authorities including FDA, European Medicines Agency (EMA), and other national authorities, to support the conduct of clinical trials and marketing applications.
- Ensures compliance of CMC activities with applicable regulatory requirements.
- Evaluates manufacturing processes and changes, assesses the regulatory implications, and support their implementation.
- Maintains current knowledge of the relevant guidelines and regulations and determine applicability to company activities.
- Other duties as assigned.
- Bachelor’s degree in life science or an equivalent combination of relevant education and applicable job experience may be considered.
- Additional consideration is given for applicants with an advanced degree in chemistry (PhD).
- A minimum of 6 years progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development.
- Level will depend on education and experience.
- A minimum of a Bachelor’s degree in life science (e.g. Chemistry, Pharmaceutics, Biochemistry, Biotechnology, Biology) or equivalent.
- Knowledge and understanding of US as well as global regulatory regulations and guidelines.
- Previous experience in authoring CMC components (Module 3) of Investigational New Drug (IND) Applications, IMPD’s for ex-US submissions. Experience in authoring New Drug Application (NDA)/Marketing Authorization Applications (MAAs) preferred.
- Ability to work in a cross-functional team environment and manage competing priorities.
- Strong interpersonal skill, attention to detail, and excellent organizational, computer, and documentation. Ability to meet deadlines and perform multiple tasks in a fast-paced setting.
- Demonstrated personal initiative, responsibility, flexibility, the ability to work under limited supervision, and the ability to handle multiple project assignments.
- 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.