Immediate Need for a part time Regulatory Strategist to support our clients needs. This person must have Oncology, IND, NDA, CMC authoring experience. They will be planning and strategizing for NDA for approval with FDA.
location: Princeton, New Jersey
job type: Contract
salary: $105 - 107 per hour
work hours: 9 to 5
- Design and execute, efficient and effective regulatory strategies for all product programs, such as Post Marketing Requirements (PMR), line extension developments, etc.
- Author briefing book for agency meetings (e.g., pre-IND, EOP-2, pre-NDA and other meetings as required).
- Author BLA/NDA and other applications for submission, as required.
- Responsible for preparing and submitting moderately to complex regulatory documents which require interactions with departments outside of Regulatory Affairs for investigational and commercial products, in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations, and original INDs/CTAs and NDAs/MAAs for assigned territories
- Strong communication, 10 to 15 years' experience working in a regulatory environment with effective project management skills
- Strong Experience in Regulatory strategy in particular with oncology, Process and Change Management, KPIs and Metrics, Project Management
- Experienced in HA liaison and seeking HA approval for products in US, EU and ROW markets
skills: CMC, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.