Job Description

Director / Senior Director, Regulatory Affairs (Clinical & CMC)

August 2025

Department: Regulatory

Position Summary:

The Director/Senior Director, Regulatory Affairs will lead and execute global regulatory strategy and operations to enable the development of our therapeutics. This individual will oversee both Clinical and CMC regulatory functions, providing strategic and operational leadership across IND/CTA submissions, clinical development programs, and CMC activities. The ideal candidate will bring deep experience in protein and antibody therapeutics and hands-on expertise in early-stage biotech environments.

Key Responsibilities:

• Lead the development and implementation of global regulatory strategies for both clinical development and CMC to support company objectives and timelines.
• Serve as the regulatory lead on project teams, providing expert guidance on regulatory requirements, risks, and opportunities across the development phases.
• Partner closely with Clinical, Nonclinical, CMC, and Quality teams to align regulatory activities with development goals.
• Advise executive leadership on regulatory matters, timelines, and risk mitigation strategies.
• Lead preparation, submission, and management of global regulatory submissions (INDs, CTAs, amendments, safety reports, briefing packages).
• Lead the preparation, submission and management of briefing documents for agency interactions
• Represent the company in global regulatory agency interactions including INTERACT, pre-IND, End-of-Phase, and Scientific Advice meetings.
• Provide regulatory input into clinical development plans, protocols, and study reports and collaborate with clinical operations to enable the clinical study.
• Collaborate with the CMC team for developing strategy and review CMC sections of regulatory submissions (Module 3) ensuring alignment with evolving global requirements.
• Collaborate with manufacturing and quality functions to ensure compliance with regulatory expectations for GMP and biologics manufacturing.

Qualifications:

• Advanced degree (PhD, PharmD, or MS preferred) in a scientific discipline relevant to biologics development.
• 10+ years of regulatory affairs experience, with significant leadership responsibilities in clinical and CMC regulatory functions.
• Proven track record of regulatory leadership in the development of antibody-based therapeutics, ideally from IND through to late-stage development.
• Hands-on experience with IND, CTA, and global health authority interactions and writing regulatory documents
• Strong working knowledge of regulatory requirements and guidelines (ICH, FDA, EMA) for both clinical and CMC biologics development.
• Experience in early-stage company; comfortable with fast paced environment and building processes fit for purpose.
• Excellent written, verbal, and interpersonal communication skills; proven ability to influence cross-functional teams and senior leadership.

Preferred Attributes:

• Experience with immune-oncology, autoimmune and metabolic therapeutic areas.
• Ability to work in a fast-paced environment and ability to manage multiple product regulatory IND/CTA filings at the same time.

Company Overview TCG Labs-Soleil, established in partnership with The Column Group , a science-focused venture capital firm, is pioneering a novel venture capital-biotech model. Our core mission is to efficiently translate scientific insights into therapeutic solutions for patients facing serious diseases. This model supports scientific entrepreneurs from the initial idea to clinical proof of concept (PoC) by combining a dedicated fund (TCG Labs) with our independent, evergreen R&D center led by a top-tier scientific team (Soleil). Together, we create an integrated ecosystem that fosters the development of single-asset portfolio companies, strategically poised for transacting after clinical PoC.

EEO Statement TCG Labs-Soleil is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation can be directed to contact@tcglsoleil.com.

Benefits and Compensation TCG Labs-Soleil provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short and Long Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), 401k plan and PTO.

The anticipated salary range for fully qualified candidates applying for this role will be $168,000 - $356,250 annually (not including discretionary bonus, equity, and benefits). The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity.

Staffing Agencies TCG Labs-Soleil does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesnt have a signed agreement with TCG Labs-Soleil. Please do not send agency CVs/resumes through TCG Labs-Soleil website or TCG Labs-Soleil Employees. Inquiries must be sent to contact@tcglsoleil.com with the Subject Heading: Staffing Agency Request.

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