Associate Director/ Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)
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
The Associate Director of Regulatory Affairs, Advertising and Promotion (Ad Promo) is a strategic role that partners cross-functionally with Marketing, Medical, Legal, Market Access, Corporate Communications, and other stakeholders to help ensure materials are compliant with country and local regulations, industry standards, and company policies while supporting business objectives.
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.
Responsibilities
- Provide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across multiple channels, including digital, social media, websites, emails, print, speaker programs, video testimonials, scientific congresses, and field communications, among others.
- Participate as a core member of MLR meetings and provide clear, practical, and risk-based regulatory recommendations.
- Confidently advise cross-functional teams on promotional strategy, claims development, fair balance, substantiation requirements, and risk mitigation.
- 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.
- Monitor and interpret evolving FDA enforcement trends, OPDP untitled/warning letters, and relevant industry developments to proactively advise internal stakeholders.
- 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.
- Provide mentorship and guidance to junior regulatory staff or consultants, as applicable.
- Participate in cross-functional initiatives related to process optimization, digital innovation, and operational excellence.
Requirements
- Bachelor’s degree required; degree in life sciences, pharmacy, regulatory affairs, or related scientific discipline preferred.
- 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
Preferred
- Product launch experience
- Experience supporting specialty, rare disease, oncology, or other complex therapeutic areas
- Global promotional regulatory experience
- Experience working in fast-paced or emerging biotech environments
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.
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Skills Required
- Bachelor's degree
- Degree in life sciences, pharmacy, regulatory affairs, or related scientific discipline
- 7+ years of experience in Regulatory Affairs Advertising & Promotion within pharmaceutical or biotechnology industry
- Direct experience leading or reviewing US prescription drug promotional materials
- Strong working knowledge of FDA-OPDP regulations, guidance, enforcement trends, and MLR processes
- Working knowledge of promotional material review (PMR) requirements in other countries
- Familiarity with Veeva PromoMats or similar review systems
- Product launch experience
- Experience supporting specialty, rare disease, oncology, or other complex therapeutic areas
- Global promotional regulatory experience
- Experience working in fast-paced or emerging biotech environments
- Current, valid authorization to work in the country where this role is located
What We Do
Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our 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. Our RNAi-based therapeutics are at the leading edge of genetic-based therapy with the potential to bring life changing treatments for patients. Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on actively targeted drug delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety. Our employees are nimble, science-driven, and innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics to add to our growing pipeline. Research and development activities are located in Madison, WI. Our R&D group includes fully-integrated capabilities for chemistry, biology, and toxicology. Madison is an exciting and sophisticated city that includes state government, the flagship campus of the University of Wisconsin, and major research organizations. Our HQ, clinical and regulatory operations are located in Pasadena, CA. Just north of Los Angeles and resting in the foothills of the San Gabriel Mountains, Pasadena is known for its natural scenic beauty, vibrant cultural and academic environment and rich architectural setting.
