Regulatory
Manager, Regulatory Affairs
Office Location: Pasadena, California, United States; San Diego, California, United States
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused 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. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
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.
Responsibilities
- Lead the preparation and submission of regulatory filings (e.g., IND, CTA/IMPD, annual reports/progress reports, briefing documents, etc.)
- Execute regulatory strategies to support product development, approval, and commercialization, ensuring alignment with the company's goals and objectives.
- 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.
- Create and maintain submission project plans, content plans, and responsibility matrices to ensure consistency and completeness to standards for all regulatory submissions.
- 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
- Monitor for and integrate regulatory intelligence/guidelines into program strategies and contribute to risk identification and mitigation planning within development teams
- Research and analyze regulatory information and maintain current regulatory knowledge
Requirements
- Bachelor’s or Master’s degree with at least five years of hands-on regulatory experience; or a PharmD, PhD, or other advanced degree with at least three years of hands-on regulatory experience.
- Strong knowledge of FDA and international regulatory requirements, regulations, and guidance.
- Proven ability to manage complex projects, priorities, and timelines within a collaborative, cross-functional matrix environment.
- Excellent written and verbal communication skills, with the ability to influence and negotiate effectively across all levels of the organization.
- Strong attention to detail and the ability to work independently, collaboratively within multidisciplinary teams, and effectively with external partners and vendors.
- Demonstrated success working in a fast-paced, entrepreneurial organization.
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.