Regulatory Affairs Manager
- Prepare standard regulatory documents including INDs, NDAs, CTAs, Meeting Requests, Briefing Books, Orphan Drug Designations (ODDs), Annual Reports, DSURs, and PADERs.
- Author cover letters and prepare agency forms for submission
- Organize and track the internal review process of regulatory documents, including reconciliation of review comments, editing, formatting, version control, and finalization within the Veeva RIM Platform
- Compile and submit study-specific regulatory documents and safety filings to trial master files
- Submit and distribute regulatory documents to Catalyst’s partners and the Pharmacovigilance group
- Track recurring regulatory activities and manage submission timelines
- Maintain the department’s regulatory submissions database
- Develop and manage regulatory project roadmaps; assist in developing regulatory plans
- Schedule regulatory project meetings and draft/distribute meeting minutes
- Provide administrative support and other duties as assigned
- Collaborate with cross-functional teams to define strategies for document authoring and preparation
- Collaborate with Regulatory Operations to enhance regulatory submission and information management capabilities within the Veeva RIM platform
- Support the implementation of the Veeva RIM platform in collaboration with internal and external stakeholders and vendors
- Assist in the development and maintenance of regulatory-specific Standard Operating Procedures (SOPs) and Work Instructions
- Use knowledge of GCP and study protocols to support regulatory compliance
- Monitor new and revised FDA recommendations and assist in preparing impact analyses
- Monitor regulatory intelligence related to the competitive landscape and assist in preparing impact assessments
- Support impact assessments related to new releases or updates made to the Veeva RIM platform
- Bachelor’s degree required (Science preferred; Non-Science and Legal backgrounds considered)
- Master’s degree (MS/MA) in Regulatory Affairs or related field–preferred
- Minimum of 3–5 years of clinical regulatory experience
- Familiarity with clinical trial and drug development regulations
- Solid understanding of Good Clinical Practice (GCP) and end-to-end regulatory submissions and archival processes
- Experience compiling and submitting regulatory documents and safety filings
- Proficiency in Veeva Regulatory Information Management (RIM) platform–required
- Strong computer skills, including MS Word, Excel, Outlook, and Adobe Acrobat
- Ability to quickly learn and adapt to new software and platforms
- Excellent written, verbal, and interpersonal communication skills
- Strong organizational, planning, and time management abilities with attention to detail
- Effective problem-solving and analytical skills
- Ability to work independently as a self-starter while maintaining a high degree of accuracy under tight deadlines
- Ability to understand complex regulatory discussions and synthesize cross-functional input across documents and projects.
- Able to coordinate cross-functional team meetings and interface professionally with internal and external stakeholders, both domestically and internationally
- Demonstrated ability to collaborate respectfully and communicate clearly within a team environment.
- Capable of identifying access or process issues and proposing appropriate resolution plans
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