Head of Global Regulatory Affairs, CMC Small Molecule

Role Summary

Head of Global Regulatory Affairs, CMC Small Molecule based in Morristown, NJ. The role leads CMC regulatory strategy and risk assessments across development projects and marketed products, aligning with global regulatory authorities to secure timely approvals while maintaining high standards of quality and compliance. You will provide leadership to a mid-to-large Regulatory CMC organization, shaping policy, strategy, and external representation with health authorities.

Responsibilities

• Provides Leadership to their group and is accountable for organizational design, people development (supervising, coaching, mentoring), resource allocation (recruitment, retention, talent development, succession planning etc.), and metrics. Demonstrates very strong leadership including influencing and negotiating skills, and conflict management and resolution. Capable of resolving and/or advising on very complex global organizational and regulatory/technical issues. Demonstrates the knowledge and behaviors that model the Sanofi and GRA Values/Principles/Competencies.
• Oversees the development of CMC regulatory strategy and regulatory risk assessments for all development projects and marketed products, in collaboration with other parts of GRA. Assures that positive and collaborative relationships are developed with CMC and Device teams to achieve the implementation of appropriate global regulatory strategies. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated, and mitigated as necessary.
• Oversees strategic negotiations with worldwide Regulatory Agencies, including directly with FDA and EMA, so that appropriate and pragmatic Regulatory CMC positions are negotiated with the highest Probability of Success (POS). Assures appropriate representation of Sanofi at Agency meetings; assures that contacts with Agencies are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships with Agencies.
• Oversees the preparation review and approval of Regulatory CMC submissions (including writing as applicable), for all development projects and marketed products to assure that they meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved. Assures directly that complex technical and regulatory CMC issues are appropriately resolved with optimal solutions. As applicable, support the regulatory inspection process for development projects and marketed products.
• Provides a vision and leadership for Policy and Regulation to assure that appropriate Sanofi representation in external activities is achieved. Monitors the review of local and international Agency regulations and guidelines. Assures that current Agency thinking, and trends (paradigm shifts) are understood and broadly communicated. Assures that associates take a leadership role externally, as appropriate, and that input is provided to position papers developed by external industry organizations and professional associations.

Qualifications

About You

• Core Experience: Minimum 10-15 years of direct Regulatory CMC experience preferred, with demonstrated progression in regulatory affairs roles and successful regulatory authority interactions.
• Leadership Background: Global Leadership experience with a mid-size/large Regulatory CMC organization, including organizational design, people leadership and development (supervising, coaching, mentoring), recruitment, retention, talent management and succession planning.
• Technical Expertise: Global Leadership experience with a mid-size/large Regulatory CMC organization, including organization design, people leadership and development (supervising, coaching, mentoring), recruitment, retention, talent management and succession planning.
• Global regulations/guidelines: Strong knowledge of key Agency/Industry thinking, trends and regulations/guidelines and be capable of resolving complex strategic technical and regulatory issues. Experience working for a Regulatory Health Authority is helpful but not essential.
• Education: Bachelor's degree required. Advanced degree (Masters, PhD) in a science or health field (i.e., Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences, etc.), or equivalent is highly desirable.
• Communication Skills: Demonstrated excellent communication and influencing skills internally and externally.
• Strategic Thinking: Demonstrated ability to assess regulatory risks, identify opportunities, and develop pragmatic solutions that align with business objectives. Demonstrated independence in thinking, anticipatory foresight, and be able to communicate effectively to broad, sophisticated audiences.
• Collaborative Leadership: Experience building and maintaining effective partnerships across functions and with external stakeholders, including health authorities.
• Travel: 20% travel expected, domestic and international

Education

• Bachelor's degree required. Advanced degree (Masters, PhD) in a science or health field (i.e., Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences, etc.), or equivalent is highly desirable.

Additional Requirements

• None beyond travel specification noted above.