Senior Director, Regulatory Affairs (Oncology)
Our Clinical-stage Biotech client is seeking your expertise to add to their Regulatory function. Come join and exciting company focused on developing next-generation precision oncology therapeutics. Utilizing a proprietary delivery technology they are able to create next-generation cancer treatments. As the Architect of the Regulatory function you will guide the internal and external Regulatory function in clinical and CMC activities as the company's lead program is currently in a Phase 1 trial. With over $125M private investment and an over $200M IPO haul this company is well funded and ready to initiate additional preclinical and clinical development pipeline programs with your help.
You will be reporting to the Chief Medical Officer in this role and be asked to provide expertise and guidance on regulatory initiatives. You should come with multiple years of experience in oncology drug regulatory guidance from IND to Phase III and beyond ideally. If you are ready to join and exciting growing Boston Biotech and accelerate your Regulatory leadership this is the home for you.
Primary Role Responsibilities:
- You will serve as regulatory leader for regulatory filings on novel therapeutic technologies in oncology pipeline
- You will also serve as regulatory lead and primary point of contact for CMC team interactions with agency contacts
- Review and prepare clinical protocols, investigator brochures, informed consents, and other GCP documentation with internal teams
- You will drive drafting of clinical trial applications, amendments, meeting briefing documents, and applications for orphan drug
- You will have experience with the delivery of e-submissions in compliance and accordance with eCTD specifications
- You will have experience in drafting Development Safety Update Safety Reports (DSURs)
- Help establish and build internal SOPs and data capture systems
Primary Role Requirements:
BS/MS/Ph.D. with 8-10 years of regulatory affairs experience ideally with Biotech companies in Phase I-III clinical development stages.
- Experience with US IND applications, global applications and change controls
- Demonstrated project management skills to successfully achieve timelines and deadlines in accordance
- Self-starter qualities to build and guide a growing organization in Regulatory Affairs from CMC to Clinical standards standpoint with little infrastructure
- You will be the type that ideally thrives in a fast-paced biotech environment and work with internal teams across two sites and with external partnership with agencies and CMC contacts to guide regulatory compliance and procedures are achieved and reported