Job Description
The Regulatory Manager will provide hands-on support for day-to-day regulatory functions. Responsibilities include the preparation, formatting, and editing of clinical components of documents for health authority submissions, maintaining the regulatory calendar of submissions, and, where applicable, managing interactions with Regulatory CROs as directed. This position can be based in our corporate HQ office- Coral Gables, Florida or remote, with one trip per quarter to HQ.
Requirements Responsibilities (Included but not limited to): - 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
Education/Experience/Skills - 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
Catalyst is committed to providing competitive wages and comprehensive benefits including health, dental, and vision insurance, generous paid time off, a retirement savings plan with Company Match, and more. Further details about our benefits package can be found here: The base salary for this position will range from $115,000 to $138,000. Candidate experience, professional licensing, and geographic location will be taken into consideration. EEO Statement Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
Recruitment & Staffing Agencies: Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.
Job Tags
Odd job, Work at office, Remote work,