Senior Director, Regulatory Affairs – Client-Dedicated Embedded Role

Description

The company works in a client-dedicated embedded model. You join the client's development organization as its senior regulatory lead while remaining part of the company.

The client is a clinical-stage biotech developing RNA-based therapeutics for oncology and immune-mediated diseases, built on a new platform. It is small, moves fast and is entrepreneurial.

You set global regulatory strategy across clinical and preclinical programs, lead health authority contact, and make sure development plans, data packages and submissions move the portfolio forward. You are a key regulatory partner to senior client leaders and cross-functional teams, and the role comes at a critical stage of portfolio development.

The role suits an experienced regulatory leader with strong strategic judgment who is also willing to work hands-on in a small biotech.

Responsibilities

• Lead day-to-day regulatory strategy and operations across assigned development programs as the embedded senior regulatory lead.
• Build and run global regulatory strategies for clinical and preclinical assets, linking them to clinical, nonclinical, CMC and wider product goals.
• Act as the main regulatory adviser to client senior leaders and cross-functional teams on strategy, portfolio planning, prioritization, risk and key decisions.
• Lead engagement with health authorities, including the US FDA (with CBER where relevant), EMA, TGA and other agencies. Prepare meetings, write briefing packages, meeting requests and position papers, answer agency questions, and follow up after meetings.
• Oversee submissions such as INDs, CTAs, amendments, designations, marketing applications and lifecycle filings, matched to the stage of each program.
• Make sure regulatory strategy and submission plans fit with clinical, nonclinical, CMC, technical operations, biostatistics, pharmacovigilance and other functions.
• Work with R&D, clinical development and CMC leaders so study designs, development plans and data packages support regulatory discussions and future filings.
• Assess emerging data and development scenarios, and recommend practical strategies for regulatory challenges without losing scientific or regulatory rigor.
• Identify routes to expedited or facilitated review, including Breakthrough Therapy, RMAT, Fast Track, Orphan Drug and other designations where appropriate.
• Help build the client's regulatory capability, operating model, processes and governance, aiming for scalability, quality, efficiency and fit for purpose.
• Coordinate regulatory work done by external vendors, consultants and service providers, and ensure their output is high quality, accountable and well integrated.
• Give regulatory expertise to multidisciplinary teams, helping them reach clear decisions when priorities shift and infrastructure is thin.
• Track evolving global regulations, guidance, precedents and regulatory science for oncology, novel modalities, RNA technologies and platforms.
• Ensure regulatory work meets applicable rules, guidance, client requirements and company procedures.
• Build trusted relationships with client stakeholders, deliver high-quality work, and communicate regulatory risks, decisions and priorities clearly.

Requirements

• Bachelor's degree or equivalent in a scientific, medical, pharmaceutical or related discipline (required).
• Advanced degree such as an MS, PharmD, PhD, MD or equivalent (preferred).
• Significant, progressive regulatory affairs experience in biotech or pharma, typically 15+ years or an equivalent mix of education, training and directly related experience.
• Extensive experience creating and running global regulatory strategies from early development through late-stage clinical work and registration.
• Demonstrated experience with INDs and/or CTAs and major global regulatory submissions.
• Experience supporting or leading BLA, MAA or comparable marketing authorization activities (highly desirable).
• Oncology drug development experience (required or strongly preferred).
• Experience with novel or advanced therapeutic modalities, such as RNA therapeutics, gene therapy, cell therapy, genetic medicines or other complex biologic platforms (highly desirable).
• Experience with expedited programs and designations such as Breakthrough Therapy, RMAT, Fast Track and/or Orphan Drug Designation (preferred).
• Demonstrated experience leading FDA and other major global health authority interactions, including preparing for and leading formal regulatory meetings.
• Experience in a small or mid-sized biotech, or proven ability to work well in a highly entrepreneurial, resource-constrained setting (strongly preferred).
• Previous experience providing senior regulatory leadership across multidisciplinary teams.
• Expert knowledge of global drug and biologics regulations, regulatory strategy, and applicable ICH and regional requirements.
• Advanced understanding of rules for early and late clinical development, marketing applications and lifecycle management.
• Strong grasp of regulatory issues in oncology and in innovative or platform-based modalities.
• Ability to turn complex science into clear, practical, executable regulatory strategies.
• Ability to assess development and regulatory risks independently, weigh strategic options and advise senior stakeholders.
• Strategic thinking plus a willingness and ability to work hands-on, directly contributing to regulatory documents, briefing materials, strategy papers and submission plans.
• Ability to work inside an embedded client team and quickly earn credibility and trusted-adviser relationships with senior executives and cross-functional leaders.
• Proven ability to work autonomously in a fast-paced, changing and sometimes ambiguous environment.
• Excellent leadership, influence, negotiation, judgment and decision-making skills.
• Excellent written and verbal communication, including explaining complex regulatory issues to scientific, operational and executive audiences.
• Strong collaboration and interpersonal skills across organizational and functional boundaries.
• Ability to juggle several complex priorities and adapt strategy as program data, business priorities and regulatory expectations change.
• Strong organization and project leadership, focused on quality, accountability and timely delivery.
• Ability to coordinate internal specialists, external consultants, vendors and other regulatory contributors when needed.

Conditions

Standard schedule, Monday to Friday.

Office-based role. Work may take place in an office, a home office, at the client site or in a clinical development environment, depending on the agreed working model.

Regular contact with client leaders and cross-functional development teams is expected.

Domestic and international travel may be required, including for client meetings and health authority interactions.

Estimated salary for this role based in North Carolina: $180,000.00 to $210,000.00.

Benefits

• May be eligible for a variable annual bonus based on company, team and/or individual performance, under company policy.
• Choice of national medical and dental plans, a national vision plan and health incentive programs.
• Employee assistance and family support programs, commuter benefits and tuition reimbursement.
• At least 120 hours of PTO, 10 paid holidays a year, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability, per company policy.
• 401(k) retirement savings plan.
• Employee stock purchase plan that lets eligible staff buy company stock at a discount.
• Full benefits details are available on the company's total rewards site.