VP, Regulatory Affairs

POSITION SUMMARY:

The Vice President of Regulatory Affairs reports to the Chief Medical Officer and leads regulatory strategy and execution across Rigel’s commercial portfolio and clinical development programs in hematology and oncology. The portfolio includes TAVALISSE (fostamatinib), REZLIDHIA (olutasidenib), GAVRETO (pralsetinib), and VEPPANU (vepdegestrant). Development activities include R289 in lower-risk myelodysplastic syndrome, other investigational agents in hematology/oncology and clinical programs evaluating opportunities for existing products.

This leader brings demonstrated commercial regulatory experience and provides strategic and practical guidance on marketed-product compliance, advertising and promotion, labeling, lifecycle management, and development from investigational applications through approval. The role partners with Commercial, Medical Affairs, Clinical Development, Pharmacovigilance, CMC, Quality, and Legal, and leads internal regulatory personnel and external service providers.

Employees designated as onsite or hybrid are expected to be onsite at Rigel’s South San Francisco headquarters during business hours on Wednesdays and Thursdays each week. Employees designated as remote are expected to be onsite during business hours on Wednesdays and Thursdays at least twice per month, and more frequently as business needs require.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead registrational strategy for investigational agents, including R289 in LR-MDS.
• Lead regulatory strategy for marketed products, including launch support, ongoing commercialization, label maintenance, supplemental applications, and lifecycle opportunities.
• Provide regulatory leadership for the medical, legal, and regulatory review of promotional materials, including sales materials, websites, digital campaigns, congress materials, and patient communications. Evaluate claim support, fair balance, risk disclosures, and consistency with approved labeling and applicable requirements.
• Oversee interactions with FDA’s Office of Prescription Drug Promotion (OPDP), Form FDA 2253 submissions, and advisory or required pre-dissemination submissions, as applicable. Provide practical guidance and training to commercial teams and review agencies.

Clinical development and regulatory leadership

• Lead prescribing information, patient labeling, packaging, and labeling negotiations and updates. Coordinate implementation of approved changes with Safety, Medical Affairs, Commercial, CMC, Quality, and supply partners.
• Oversee regulatory tracking and fulfillment of postmarketing requirements and commitments, including confirmatory study obligations where applicable, in partnership with Clinical Development and Safety. Coordinate required regulatory reporting with the responsible functions.
• Develop integrated regulatory plans for clinical programs, including R289 and potential new indications or combinations for existing products. Advise on study design, endpoints, development milestones, and evidence needed to support approval.
• Serve as the primary regulatory interface with FDA and coordinate interactions with EMA, MHRA, Health Canada and other health authorities, directly or through partners and service providers. Lead agency meeting strategy, briefing packages, negotiations, and responses.
• Coordinate regulatory activities with business partners.
• Direct preparation, review, and timely submission of investigational new drug applications (INDs), new drug applications (NDAs), supplemental NDAs, clinical trial applications (CTAs), marketing authorization applications (MAAs), amendments, annual reports, and other required filings, as applicable to Rigel’s responsibilities and licensed territories.
• Partner with Clinical Development, Medical Writing, Biostatistics, Nonclinical, CMC, Pharmacovigilance, Quality, and Legal to ensure consistent regulatory strategy and submission content. Oversee regulatory labeling, writing, operations, and electronic submission activities through internal staff or service providers.
• Provide regulatory assessment of biomarker and companion diagnostic requirements for relevant oncology programs, coordinating with clinical teams, diagnostic partners, and health authorities as needed.
• Represent Regulatory Affairs on development and portfolio leadership teams. Present regulatory risks, options, timelines, and recommendations to the Chief Medical Officer and executive management.
• Support business development due diligence, in-licensing, acquisitions, and product integration. Assess regulatory risks, approval histories, labeling, outstanding obligations, and the transition of applications and regulatory responsibilities.
• Lead, mentor, and develop the regulatory team, including Regulatory Affairs directors, managers, CMC Regulatory Affairs Director and medical writers; manage consultants, vendors, budgets, and resources across commercial and development priorities. Establish clear responsibilities and effective collaboration with licensing partners.
• Maintain effective regulatory procedures, document management, submission records, and inspection readiness. Partner with Quality on audits, inspections, and corrective actions affecting Regulatory Affairs; monitor changing requirements and train affected teams.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Bachelor’s degree in a life sciences or related scientific discipline, or equivalent relevant experience; an advanced degree is preferred.
• At least 15 years of pharmaceutical or biotechnology industry experience, including a minimum of 10 years in Regulatory Affairs, with progressive leadership responsibility.
• Demonstrated commercial regulatory experience with FDA-approved prescription medicines is required, including advertising and promotional review, OPDP interactions and submissions, labeling, post-approval changes, and lifecycle management. Experience supporting product launches and ongoing commercial operations is required.
• Strong working knowledge of FDA requirements for prescription drug promotion and labeling, including evaluation of promotional claims, benefit and risk presentation, and collaboration with Commercial, Medical Affairs, and Legal.
• Proven success leading regulatory strategy, FDA interactions, and NDA or supplemental NDA submissions through approval, with experience supporting clinical development from early studies through registration. International regulatory submission experience is preferred.
• Hematology or oncology regulatory experience is required; experience with hematological malignancies, biomarker-defined populations, oral small molecules, accelerated approval pathways, and postmarketing commitments is preferred.
• Experience leading regulatory teams and external providers, managing competing priorities, and delivering high-quality submissions in a commercial biotechnology environment. Experience with product in-licensing and regulatory transfers is preferred.
• Strong scientific judgment, analytical and problem-solving skills, and the ability to explain regulatory risks and recommendations clearly. Effective negotiation, written communication, and cross-functional leadership skills are essential. FDA advisory committee experience is preferred.

COMPENSATION AND BENEFITS:

The anticipated salary range for this position is $335,000 to $380,000. The actual salary offered will depend on several factors, including experience, qualifications, geographic location, internal equity, and business needs.

This position is eligible to participate in Rigel's annual bonus program and is eligible for equity incentive awards, subject to the terms of the applicable plans. This position is not commission-based.

Rigel offers eligible employees a comprehensive benefits package, including medical, dental, and vision coverage; life and disability insurance; flexible spending accounts; a 401(k) plan; paid time off; paid company holidays; and other benefits.

WORKING CONDITIONS:

• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
• WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.