Senior Regulatory CMC Consultant (vaccine or mAb) - REMOTE
Under the direction of the functional area lead, this role will shepherd the CMC regulatory content and narrate the program history and plan (i.e., tell the regulatory story).
- Draft initial IND application-level content for CTD Modules 3 and 4 as a template to capture development work currently in progress for a vaccine candidate and to help focus development of the remaining content in a pro-active fashion.
- Conduct technical writing and author appropriate CMC-related content and documents (e.g., narrative program plans, briefing documents etc.).
- As needed, facilitate project meetings and coordination related communication (e.g., meeting agendas, meeting minutes, follow-up items).
- Coordinate day-to-day activities in the context of the related project schedule and influence changes and alignment to that schedule based on their expertise and experience (e.g., daily execution of contracted activities).
- Unique capabilities or experience required (mAb)
- vaccine or mAbs experience would be beneficial either in manufacturing, analytical or process development setting
- 8 years of vaccine experience in a biological/biopharmaceutical product development and/or analytical development setting vital.
- BS in a biological science or related field
- Excellent communications skills, both written and verbal
- Proactive solution oriented team player. Self-motivated individual.
- 4 years of experience authoring CTD Module 3 contributions to initial IND applications for biologics
- 6 years of experience in CMC regulatory affairs for biologics, including as CMC regulatory representative on project teams
- Technical and regulatory experience both in small to medium-sized biotech company (-ies) and in big biopharma settings that include early and late stage development biological products, ideally prophylactic vaccines
- Experience with biological products based on eukaryotic cell culture, ideally mammalian cell culture
- Experience participating in FDA meetings and in responding to questions from regulatory authorities
- Experience with US regulatory submissions and health authority interactions.
- Experience with license applications (BLA, MAA) and with CMC life cycle management (to add perspective to early development activities, i.e., beginning with the end in mind.
- Experience working remotely and with a virtual team.
Resumes without the appropriate Biotech/Pharmaceutical expereince will not be reviewed.