BioSpace
Overview
Join to apply for the
Regulatory Affairs Manager
role at
BioSpace .
Location: Coral Gables, FL (HQ) or remote, with one quarterly trip to HQ.
Responsibilities 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
Benefits 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:
https://www.linkedin.com/company/catalystforrare/life/life-at-catalyst/?viewAsMember=true
Compensation 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.
Seniority level Mid-Senior level
Employment type Full-time
Job function Legal
Industries Internet News
Referrals increase your chances of interviewing at BioSpace by 2x
Coral Gables, FL
$115,000.00-$138,000.00
#J-18808-Ljbffr
Regulatory Affairs Manager
role at
BioSpace .
Location: Coral Gables, FL (HQ) or remote, with one quarterly trip to HQ.
Responsibilities 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
Benefits 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:
https://www.linkedin.com/company/catalystforrare/life/life-at-catalyst/?viewAsMember=true
Compensation 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.
Seniority level Mid-Senior level
Employment type Full-time
Job function Legal
Industries Internet News
Referrals increase your chances of interviewing at BioSpace by 2x
Coral Gables, FL
$115,000.00-$138,000.00
#J-18808-Ljbffr