Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals

Associate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)

Pasadena, California, United States · Director

Sponsorship not specified$180k-$200kDetected 19 days ago
Process ImprovementFDA RegulatoryResearchAnimal StudiesCommunicationMentoringOrganizational SkillsRegulatory Affairs

About the role

  • 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.

Responsibilities

  • Manage all submissions to FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB), including the timely and accurate FDA 2253 submissions of US promotional materials.
  • Support review and approval of corporate and external communications, as applicable.
  • Support launch readiness activities
  • Contribute to the development and continuous improvement of internal policies, SOPs, guidance documents, and review standards.
  • Collaborate effectively across functions to support timely and compliant material development and approvals.

Requirements

  • Bachelor's degree required
  • 7+ years of experience in Regulatory Affairs Advertising & Promotion within the pharmaceutical or biotechnology industry.
  • Direct Experience leading or reviewing US prescription drug promotional materials required.
  • Strong working knowledge of FDA-OPDP regulations and guidance governing pharmaceutical advertising and promotion, enforcement trends, and MLR processes and procedures
  • Working knowledge of PMR requirements in other countries
  • Familiarity with Veeva PromoMats or similar review systems
  • Experience supporting specialty, rare disease, oncology, or other complex therapeutic areas
  • Experience working in fast-paced or emerging biotech environments

Nice to have

  • 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'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 ideal candidate is a collaborative and solutions-oriented regulatory professional with strong communication and organizational skills and the ability to balance regulatory risk with commercial innovation.
  • The candidate should have experience leading or facilitating US promotional review committees (MLR) and oversight of vendors providing promotional material review (PMR) services in other countries.
  • Experience supporting product launches is preferred.

Compensation

  • California pay range
Apply directly at Arrowhead Pharmaceuticals →Create a free account for alerts like thisView Arrowhead Pharmaceuticals immigration profile

This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.