Job Title: Associate Director, Regulatory Operations
Job Number: 21998
Location: Cambridge, MA
Casebia Therapeutics is seeking an Associate Director of Regulatory Operations with a passion for delivering breakthrough therapeutics for patients. The candidate will play an integral part in the growing Regulatory team and will support the developing life-changing therapies using Casebia’s proprietary gene-editing technology. The ideal candidate will have at least 7 years in Regulatory Operations within the biotech or pharma industries. The AD Regulatory Operations oversees the technical preparation, submission, and archiving of all regulatory submissions, and ensures that all submissions to regulatory authorities are produced on time per project timelines and comply with regulatory authority requirements. This person plays a critical leadership role to effectively publish and submit timely, high-quality, compliant regulatory submissions.
- Working with project teams, develop regulatory submission plans for all submissions, using appropriate project management tools and techniques, to ensure proper tracking of all regulatory submission deliverables.
- Responsible for the creation, assembly, and publishing of global submissions, including, INDs, CTAs, MAAs/BLAs, Annual Reports, Periodic Safety Reports, etc.
- Interface with Project Management, Project Leads, Regulatory Leads, Medical Writing and/or content authors to discuss routine and non-routine submission preparation.
- Liaise with functional source areas to ensure documents are compliant and submission ready. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
- Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
- Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
- May manage contract staff and vendors as needed to support Regulatory activities.
- Identify potential risks to submission plans and propose risk mitigation strategies.
- Provide recommendations on resource needs for regulatory operations activities including the need for outsourcing (e.g., eCTD vendor, SPL vendor).
- Serve as system owner for regulatory publishing tools and systems (eg, eCTD publishing tools, regulatory information system (RIM), electronic document management system (EDMS), library system, and electronic templates), and ensure that regulatory publishing tools and systems are implemented, validated, and maintained in accordance with company SOPs and applicable regulations.
- Bachelor’s Degree
- 7+ Years of eCTD publishing experience (global eCTD filing experience preferred)
- Experience in a small biotech company environment preferred
- Submission and Document Level Publishing experience
- Knowledge of health authority procedures/guidance's regarding electronic submissions required
- Experience with IND and CTA submissions
- Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic
- Knowledge of industry trends regarding electronic submissions
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Excellent organization, written/verbal communication, and attention to detail
- Knowledge of health authority procedures/guidance's regarding electronic submissions
- Knowledge of Electronic Document Management Systems and Publishing Systems
- Ability to balance multiple tasks to meet priorities and timelines
- Strong attention to detail
- Ability to work independently with minimal supervision, and to take ownership and responsibility
- Ability to work cooperatively with teams including alliance partners and influence cross-functionally
- Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities
- Demonstrated ability to communicate clearly, concisely, and effectively