Manager, Regulatory Affairs

Location

Coral Gables, FL | United States

Job description

The Regulatory Manager will provide hands-on support to the day-to-day Regulatory functions, including preparation, formatting, and editing of clinical components of documents for health authority submissions, maintaining the regulatory calendar of submissions, and, if applicable, managing Regulatory CRO interactions, as directed.

• Performs day-to-day regulatory activities for projects, including preparation of standard documents, such as INDs, NDS, CTAs, Meeting Requests, Briefing Book, NDA/IND/ODD, Annual Reports, DSUR, PADER, etc.
• Creation and coordination with cross-functional teams on regular document preparation and strategies.
• Organize and track the internal review process of regulatory documents, reconciliation of review comments, editing, formatting, version tracking, and finalization of the documents.
• Compile safety filings.
• Write submission cover letters and prepare the agency forms for submission.
• Distribution of regulatory documents to the Catalyst’s partners and Pharmacovigilance group
• Maintain the department’s database of regulatory submissions.
• Tracks recurring regulatory activities and manages submission timelines.
• Develops and manages project roadmaps and assists in developing regulatory plans.
• Schedules regulatory project meetings and writes/distributes minutes.
• Routinely monitors for new and revised FDA recommendations and assists in issuing impact analyses.
• Routinely monitors regulatory intelligence of the competitive landscape and assists in impact assessments.
• Submit files for study-specific regulatory documents from agencies to the trial master files.
• Assist in developing and maintaining regulatory-specific Standard Operating Procedures and Work Instructions
• Provide administrative support and other duties as assigned.
• Use knowledge of GCP and protocols

• Ability to comprehend regulatory discussions and process information learned across regulatory projects and documents.
• Ability to independently identify access solutions and determine the appropriate resolution plan.
• Ability to coordinate regular cross-functional team meetings. 
• Time management, organization, planning, multi-tasking, and prioritization skills in a fast-paced environment are required.
• Ability to maintain high accuracy and attention to detail while meeting deadlines for assigned projects.
• Excellent written and verbal communication skills and interpersonal skills.
• Ability to communicate effectively and collaboratively as part of a team respectfully.
• Ability to interface with professionals domestically and abroad.
• Ability to work independently, self-starter.
• Good problem-solving skills and analytical ability
• Strong computer skills to learn new programs as quickly as possible. Experience in MS Word, Excel, Outlook, and Adobe Acrobat is a must.
• Ability to compile submission-ready safety filings and standard regulatory documents.
• Submit regulatory documentation as needed.
• Occasional business-related travel is expected.  This is generally expected to be quarterly travel to the Company’s Home Office or related location. 

• Bachelor's degree required (Science preferred, Non-Science and Legal considered) or related targeted experience.
• Master’s degree (MS/MA) in Regulatory Affairs or related field – Preferred
• Clear understanding of Good Clinical Practice (GCP)
• Minimum of 3-5 years of clinical regulatory experience
• Familiar with clinical trial and drug development regulations

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

Salary