Arrowhead Pharmaceuticals
Associate Director, Regulatory Affairs
Arrowhead Pharmaceuticals, Pasadena, California, United States, 91122
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.
Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. The company focuses on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. Our pipeline includes targets in the liver and lung, and we are leading the field in bringing the promise of RNAi to address diseases outside of the liver.
The Position This global regulatory lead position is responsible for leading a late‑stage cardio‑metabolic program, supporting multiple early‑phase global regulatory projects, and ensuring compliance with all relevant regulatory requirements and guidelines. The role reports to the Executive Director, Regulatory Affairs and collaborates with regulatory and other departments to ensure alignment and consistency in regulatory strategies and submissions.
Responsibilities
Lead the preparation and submission of regulatory filings (e.g., NDA, MAA, supplements, variations, IND, CTA, annual reports/progress reports, briefing documents).
Prepare and coordinate Health Authority interactions.
Manage regional regulatory affiliates (and consultants) in preparation and submission of global marketing authorization applications.
Create and implement submission project plans, content plans, and responsibility matrices to ensure consistency and completeness to standards for all regulatory submissions.
Monitor and coordinate timelines of key program activities and tracking of 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.
Ensure day‑to‑day regulatory requirements are met for assigned programs (e.g., archiving, submissions).
Liaise with CRO(s) for submissions and ensure accuracy.
Requirements
Education equivalent to a BS or MS, plus 8 years of hands‑on regulatory experience, or
Education equivalent to a higher degree (PharmD or PhD), plus 6 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.
Excellent written and verbal communication skills, including negotiation.
Ability to manage and execute on multiple projects ranging from complex to highly detailed administrative tasks.
Attention to detail and ability to work individually, within a multi‑disciplinary team, and with external partners and vendors.
Demonstrated ability to excel in smaller entrepreneurial organizations.
Writing de‑novo regulatory documents (e.g., cover letters, meeting requests, briefing books).
Experience in review of ICFs, Phase 1‑4 clinical protocols, IBs, etc., to ensure they meet regulatory requirements and agreements.
Preferred
Led or experienced in market application filing (BLA/NDA or supplements/variation with clinical data).
Led a health authority interaction (meeting or primary contact for IND/CTAs).
Preparing/Writing de‑novo regulatory meeting requests/briefing books.
Pay Range California: $180,000—$215,000 USD.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
California Applicant Privacy Policy.
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Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. The company focuses on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. Our pipeline includes targets in the liver and lung, and we are leading the field in bringing the promise of RNAi to address diseases outside of the liver.
The Position This global regulatory lead position is responsible for leading a late‑stage cardio‑metabolic program, supporting multiple early‑phase global regulatory projects, and ensuring compliance with all relevant regulatory requirements and guidelines. The role reports to the Executive Director, Regulatory Affairs and collaborates with regulatory and other departments to ensure alignment and consistency in regulatory strategies and submissions.
Responsibilities
Lead the preparation and submission of regulatory filings (e.g., NDA, MAA, supplements, variations, IND, CTA, annual reports/progress reports, briefing documents).
Prepare and coordinate Health Authority interactions.
Manage regional regulatory affiliates (and consultants) in preparation and submission of global marketing authorization applications.
Create and implement submission project plans, content plans, and responsibility matrices to ensure consistency and completeness to standards for all regulatory submissions.
Monitor and coordinate timelines of key program activities and tracking of 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.
Ensure day‑to‑day regulatory requirements are met for assigned programs (e.g., archiving, submissions).
Liaise with CRO(s) for submissions and ensure accuracy.
Requirements
Education equivalent to a BS or MS, plus 8 years of hands‑on regulatory experience, or
Education equivalent to a higher degree (PharmD or PhD), plus 6 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.
Excellent written and verbal communication skills, including negotiation.
Ability to manage and execute on multiple projects ranging from complex to highly detailed administrative tasks.
Attention to detail and ability to work individually, within a multi‑disciplinary team, and with external partners and vendors.
Demonstrated ability to excel in smaller entrepreneurial organizations.
Writing de‑novo regulatory documents (e.g., cover letters, meeting requests, briefing books).
Experience in review of ICFs, Phase 1‑4 clinical protocols, IBs, etc., to ensure they meet regulatory requirements and agreements.
Preferred
Led or experienced in market application filing (BLA/NDA or supplements/variation with clinical data).
Led a health authority interaction (meeting or primary contact for IND/CTAs).
Preparing/Writing de‑novo regulatory meeting requests/briefing books.
Pay Range California: $180,000—$215,000 USD.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
California Applicant Privacy Policy.
#J-18808-Ljbffr