Director, Regulatory Affairs Strategy – Cell Therapy

• Contribute to and implement the global regulatory strategy for a complex CGT product or indication from current stage through key submission milestones; support product maintenance activities as needed.


• Serve as regulatory lead for a product, indication, or defined program component; may serve in a dual role as Global Regulatory Lead and regional regulatory lead.


• Ensure regulatory strategies enable an efficient path to approval with competitive labeling aligned to product characteristics and business, market, and patient needs; contribute to governance presentations.


• Drive strategy and execution for Health Authority meetings, responses to information requests, expedited pathway designations, and BLA development and submission.


• Maintain strong disease area knowledge; lead objective assessments of emerging data versus program aspirations; communicate risks and mitigation plans to senior management.


• Support delivery of all project-related regulatory milestones, including probability-of-success assessments and mitigation strategies.


• Lead preparation of regulatory strategy documents and target product labeling; support planning and assembly of the global dossier and core prescribing information with the respective teams.


• Operate as a core member of the Global Product Team and Global Regulatory Strategy Team, demonstrating strong strategic, communication, and collaboration skills to advance development objectives.


• Participate in non-project initiatives to enhance regulatory processes, tools, and practices; foster knowledge sharing across locations and therapy areas.


• Partner with country organizations and regional regulatory colleagues to align on evolving views, local considerations, and regulatory guidance.


• Provide mentoring and matrix support to less experienced colleagues; may have limited line management responsibilities.

Requirements

• An advanced degree in a science related field and typically five to eight years of experience and/or appropriate knowledge/experience.


• Understanding of global regulatory science and integration with program strategy.


• Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.


• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.


• Proven experience leading regulatory and cross-functional teams, and stakeholder management.


• Ability to think strategically and critically and evaluate risks to regulatory activities.


• Previous experience in leading Health Authority interactions in major markets.


• Excellent oral, written, and presentation skills.


• Strong organizational skills.


• Ability to work in a fast-paced environment in a hands-on fashion.


• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.

Demonstrates expertise in global regulatory strategy and drug development processes, with a strong ability to lead regulatory submissions and Health Authority interactions. Possesses excellent communication and organizational skills to manage multiple projects and align cross-functional teams effectively.

Highest-signal resume keywords

• Global Regulatory Strategy


• Regulatory Submissions


• Health Authority Interactions


• Stakeholder Management


• Drug Development Processes

ATS Optimization Keywords

Hard Skills

• Regulatory Strategy Development


• BLA Development


• Regulatory Documentation Preparation


• Probability-of-Success Assessments


• Emerging Data Assessment

Soft Skills

• Strategic Thinking


• Critical Evaluation


• Communication Skills


• Organizational Skills


• Mentoring

Industry Keywords

• Pharmaceutical Business


• Regulatory Affairs


• Complex CGT Products


• Project Management


• Fast-Paced Environment