Manager/Sr. Manager – Regulatory Affairs
| Company | Arrowhead Pharmaceuticals |
|---|---|
| Location | San Diego, CA, USA |
| Salary | $120000 – $170000 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PharmD, PhD |
| Experience Level | Senior |
Requirements
- Education equivalent to a BS or MS, plus 5 years of hands-on regulatory experience, or Education equivalent to a higher degree (PharmD or PhD), plus 3 years of hands-on regulatory experience
- Experience with international regulatory submissions
- Experience using Veeva RIM and SmartSheets
- Knowledgeable in ICH and FDA guidelines relevant to clinical aspects of product development
- Ability to manage complex projects and timelines in a collaborative matrix team environment
- Ability to communicate effectively (verbal and written) to multiple levels in the organization with strong negotiation skills
- Ability to manage and execute on multiple projects ranging from complex to highly detailed administrative tasks
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
- Demonstrated ability to excel in smaller entrepreneurial organizations
- Writing de-novo regulatory documents (eg, Cover letters, meeting requests, briefing books etc.)
- Experience in review of ICFs, Phase 1-4 clinical protocols, IBs, etc. to ensure they meet regulatory requirements and agreements
Responsibilities
- Lead the preparation and submission of regulatory filings (e.g., IND, CTA/IMPD, annual reports/progress reports, briefing documents, etc.)
- Participate or lead the preparation for Health Authority interactions
- Collaborate with the global regulatory lead and regional regulatory affiliates (and consultants) in preparation and submission of global marketing authorization applications.
- Work with global regulatory lead to create and maintain submission project plans, content plans, and responsibility matrices to ensure consistency and completeness to standards for all regulatory submissions.
- Work with regulatory leads to monitor timelines and key program activities and tracking submission deliverables to maintain target submission dates.
- Assess and communicate regulatory requirements to ensure all development activities are conducted in compliance with applicable regulations and guidelines
- Ensure timely and accurate communications of regulatory updates and decisions to internal stakeholders.
- Provide regulatory support and guidance to various departments, programs, and teams with a strong emphasis on frequent interactions with technical teams
- Review technical documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals
- Research and analyze regulatory information and maintain current regulatory knowledge
- Ensures day-to-day regulatory requirements are met for their assigned programs and manager (i.e., archiving, submissions)
- Liaises with CRO(s) for submissions and ensures accuracy
Preferred Qualifications
- Experience in submission of CTAs globally (i.e. EU, UK, Canada, New Zealand, Australia, Taiwan)
- Filing experience (new IND, and/or BLA/NDA original / efficacy supplements)
- Maintenance of INDs, CTAs, BLA/NDAs
- Preparing/Writing de-novo regulatory meeting requests/ briefing books