Senior Specialist, Regulatory Affairs
ImmunityBio, Inc.
9 hours ago
Remote friendly (Summit, NJ)
United States
Corporate Functions
Position Summary
- The Senior Specialist, Regulatory Affairs provides expertise in the development of regulatory compliance strategies and ensures conformance to Health Authority requirements.
Essential Functions
- Serve as a Regulatory Affairs subject matter expert to the team and organization.
- Approve, review, or prepare common technical documents (CTD) for technical content and regulatory compliance.
- Maintain compliance with US and International Health Authority regulations for both products under development and marketed products.
- Assist with developing and evaluating regulatory strategy.
- Track internal/external changes, trends, and developments in the regulatory environment affecting products.
- Author and review departmental SOPs and other SOPs impacting Regulatory Affairs.
- Perform other special projects and duties as requested.
Education & Experience
- Bachelor’s in life sciences required with 7+ years of relevant regulatory compliance experience in pharmaceutical drug development; OR
- Master’s in life sciences required with 5+ years of relevant regulatory compliance experience in pharmaceutical drug development.
- Knowledge/experience organizing responses to Regulatory Authority requests required.
- Experience with US and International Health Authority regulatory submissions preferred.
Knowledge, Skills, & Abilities
- Knowledge of FDA, ICH, and other guidance documents and requirements.
- Knowledge of organizing responses to Regulatory Authority requests.
- Strong knowledge of Health Authority regulatory requirements/guidelines.
- Strong project management and computer skills (including Microsoft Office).
- Strong document management experience (hard and e-copy).
- Ability to meet deadlines and adapt to changing requirements/priorities.
- Strong organizational skills; strong written/oral communication and attention to detail.
- Ability to manage conflicting priorities.
Working Environment
- Full-time (40 hours/week), Monday through Friday.
- Desk-based role; may sit for long periods and use computer programs; close study of scientific and regulatory documents.
Benefits & Compensation (as stated)
- Discretionary bonus and equity award.
- Base pay range: $135,000 (entry-level) to $150,000 (highly experienced) annually.
- Application window: closes 60 days from posting or sooner if filled/closed.
- The Senior Specialist, Regulatory Affairs provides expertise in the development of regulatory compliance strategies and ensures conformance to Health Authority requirements.
Essential Functions
- Serve as a Regulatory Affairs subject matter expert to the team and organization.
- Approve, review, or prepare common technical documents (CTD) for technical content and regulatory compliance.
- Maintain compliance with US and International Health Authority regulations for both products under development and marketed products.
- Assist with developing and evaluating regulatory strategy.
- Track internal/external changes, trends, and developments in the regulatory environment affecting products.
- Author and review departmental SOPs and other SOPs impacting Regulatory Affairs.
- Perform other special projects and duties as requested.
Education & Experience
- Bachelor’s in life sciences required with 7+ years of relevant regulatory compliance experience in pharmaceutical drug development; OR
- Master’s in life sciences required with 5+ years of relevant regulatory compliance experience in pharmaceutical drug development.
- Knowledge/experience organizing responses to Regulatory Authority requests required.
- Experience with US and International Health Authority regulatory submissions preferred.
Knowledge, Skills, & Abilities
- Knowledge of FDA, ICH, and other guidance documents and requirements.
- Knowledge of organizing responses to Regulatory Authority requests.
- Strong knowledge of Health Authority regulatory requirements/guidelines.
- Strong project management and computer skills (including Microsoft Office).
- Strong document management experience (hard and e-copy).
- Ability to meet deadlines and adapt to changing requirements/priorities.
- Strong organizational skills; strong written/oral communication and attention to detail.
- Ability to manage conflicting priorities.
Working Environment
- Full-time (40 hours/week), Monday through Friday.
- Desk-based role; may sit for long periods and use computer programs; close study of scientific and regulatory documents.
Benefits & Compensation (as stated)
- Discretionary bonus and equity award.
- Base pay range: $135,000 (entry-level) to $150,000 (highly experienced) annually.
- Application window: closes 60 days from posting or sooner if filled/closed.