Manager/Sr. Manager, Regulatory Affairs

Arrowhead Pharmaceuticals, Inc.•San Diego, CA

54d

About The Position

This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements and guidelines, and develop and execute regulatory plans. This position will report to the Director, Regulatory Affairs and collaborate with regulatory and other departments to ensure alignment and consistency in regulatory strategies and submissions.

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

Nice To Haves

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

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