The RFT Group
Director of Regulatory Affairs CMC
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Regulatory Affairs Director CMC
Our client is a young, exciting, publicly listed clinical-stage company dedicated to transforming the lives of patients in its therapy areas. With its novel and proprietary drug products and current clinical development programs, our client aims to provide improved treatments for patients with increased remission rates, faster onset of action, durable effects, and improved tolerability and convenience. This requires experience and a track record of successful development in complex and innovative areas, and excitement for creating something new and groundbreaking.
Overall Purpose
We’re looking for a Director of Regulatory Affairs CMC (combination products) to work closely with the existing regulatory team, internal and external experts, and collaborate and contribute towards successful execution of their pivotal clinical program and commercialization. This requires practical experience and a proven track record in overseeing CMC regulatory activities in complex and innovative areas, preferably with experience of inhaled products.
Key Duties and Responsibilities
- Lead the development and execution of the global CMC regulatory strategy across all pipeline programs, from Phase 1 through to marketing authorization, ensuring alignment with overall development strategy and company timelines.
- Author, review, and take overall accountability for high-quality CMC sections of regulatory submissions, including Module 3 (CTD), IMPDs, INDs, and responses to agency questions, ensuring compliance with eCTD requirements and international guidelines.
- Lead CMC interactions with regulatory agencies, including the FDA and EMA, taking primary responsibility for the preparation and execution of formal meetings (Type B/C meetings, scientific advice, EOP2) and ensuring robust follow-through on agency commitments and feedback.
- Provide CMC regulatory leadership for combination product development programs, working closely with technical development and device teams to ensure compliance with applicable regulatory frameworks across US, EU, and UK markets.
- Act as the CMC regulatory representative on cross-functional product development teams, providing strategic guidance on manufacturing, analytical, and quality matters and ensuring CMC regulatory considerations are integrated into program planning from the outset.
- Provide operational and technical support to the Senior Director, Device Regulatory Affairs.
- Support the establishment and ongoing development of the Quality Management System (QMS), including contributing to the authoring and review of CMC-relevant SOPs, quality agreements, and regulatory procedures in a growing GMP environment.
- Oversee the management and maintenance of CMC regulatory submissions and correspondence using regulatory document management systems, ensuring version control, audit-readiness, and compliance with document retention policies.
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- Proactively monitor and interpret changes in the global CMC regulatory landscape (ICH guidelines, FDA/EMA guidance updates, manufacturing and quality standards), communicate impacts to internal stakeholders, and adapt regulatory strategies accordingly.
- Champion the adoption of emerging technologies, including AI-driven tools within regulatory affairs and CMC operations, identifying opportunities to enhance efficiency, submission quality, and regulatory intelligence.
- Maintain and develop external regulatory networks and CMC expertise, proactively identifying training and development opportunities and keeping the organization at the forefront of evolving CMC regulatory science and best practice.
- Maintain a professional and credible image with regulatory agencies, CMC consultants, CDMOs, vendors, and internal colleagues, acting as an ambassador for the highest standards of CMC regulatory practice.
- Provide regulatory oversight of CMC activities conducted by external partners including CDMOs and regulatory vendors, ensuring deliverables meet quality standards and are aligned with submission timelines and agency expectations.
Person Spec
- Bachelor's degree or advanced degree (MS, PhD, or MD) in Life Sciences or a Health-Related discipline.
- Demonstrated experience authoring Module 3 (IND/NDA) submissions and Investigational Medicinal Product Dossiers (IMPDs), with a strong command of CMC documentation standards across global regulatory frameworks.
- Proven track record supporting CMC regulatory strategy from Phase 1 through late-stage development, with experience navigating the evolving requirements at key development milestones.
- Experience leading CMC interactions with the FDA including the preparation, coordination, and execution of formal regulatory meetings.
- Direct experience with End-of-Phase 2 (EOP2) meetings, including strategic preparation and managing agency feedback on CMC programs.
- Experience supporting the development and regulatory strategy for combination products, with an understanding of the applicable regulatory frameworks for both drug and device components.
- Experience contributing to the establishment and implementation of Quality Management Systems (QMS) in a regulated environment.
- Proficiency with regulatory document management systems and electronic submission platforms.
- Knowledge of global regulatory guidelines, GxPs, local regulations, and industry best practices.
- Ability to understand and interpret clinical data/information and its practical application in regulatory contexts.
- Experience of technical/regulatory writing (e.g. briefing books, responses to questions).
- Experience of working with multi-located cross-functional teams including in an outsourcing model using regulatory vendors.
- Proficient in pertinent software such as Microsoft Office Suite and Adobe Acrobat.
- Experience with a range of inhaled products.
- A genuine interest in the application of artificial intelligence and emerging technologies within regulatory affairs, and an enthusiasm for how these tools can enhance regulatory strategy and operations.
- Comfort operating within a small biotech environment, with the ability to work with agility, take ownership across multiple workstreams, and contribute beyond a narrowly defined role.
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Knowledge and Abilities
- Strong attention to detail with exceptionally high standards for document and submission quality.
- Excellent written/oral communication skills.
- Excellent organization skills.
- Team oriented and flexible.
- Able to manage conflicting priorities.
- The attitude and ability to be effective in a lean, small company environment in early-stage research biotech business in pre-revenue/profits phase.
- Ability to embrace and drive change across functions.
- Energetic and enthusiastic.
- An entrepreneurial, business-oriented mindset and a strong fit with the team; willing to “roll their sleeves up”.
Competencies
Technical Capability / Accountability / Decision Making / Communication / Collaboration / Leadership
Gerry Kennedy,
Managing Director,
Recruitment for Technology Ltd.
gerry@rftgroup.ie 00 353 87 2834400
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