Position Summary:
Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA development and maintenance for support of new and ongoing clinical trials, as well as planning for future MAA/NDA/BLA(s). This role requires an independent, self-directed, and highly motivated regulatory professional.
Position Responsibilities:
- Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements.
- Prepare and/or review CMC regulatory documents and submissions to support product development (e.g. ND/CTAs, DSUR, health authority briefing document, iPSP/PIP, NDA/MAA) Provide oversight of regulatory submission content and planning, to assure technical accuracy, compliance, and completeness.
- Assess proposed CMC changes (e.g., manufacturing processes, analytical methods, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies.
- Collaborate cross-functionally on the eTMF processes and compliance alignment.
- Represent regulatory on study and program teams throughout study conduct and product development.
- Support or lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required.
- Review relevant clinical and CMC documents (protocol, informed consent form, investigator’s brochure, and site quality documentation, and required regulatory forms) for regulatory compliance and consistency across submission components.
- Maintain current knowledge of US and international CMC regulation requirements that apply to company products and processes.
- Support or lead development of internal Erasca SOPs and processes, as needed.
- May support other global submission activities as appropriate, independently or in collaboration with the Regulatory Affairs project lead.
- Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.
Position Requirements:
- Undergraduate degree required; advanced degree preferred.
- 5+ years of experience in pharmaceutical or biotech regulatory affairs or related areas, including regulatory affairs for oncology products.
- Ability to translate regulatory requirements into practical workable plans.
- Diverse experience with regulatory activities including creation of systems and processes to support efficient and high quality submission of documents to regulatory bodies.
- Strong organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail.
- Ability to build strong relationships with co-workers of various backgrounds and expertise.
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
- Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.
- Strong learning orientation, curiosity, and commitment to science and patients.
