Merck
Executive Director, Regulatory CMC Small Molecule New Products
Merck, Rahway, New Jersey, us, 07065
Overview
Executive Director, Regulatory CMC Small Molecule New Products – Merck, Rahway, NJ Role location: Rahway, NJ. This role leads the CMC regulatory strategy for pre-approval and lifecycle management of small molecule and new modalities, including respiratory/inhalation, peptide, and antibody-drug conjugates (ADCs). The position collaborates across Regulatory Affairs CMC, R&D, Manufacturing and Global Human Health to ensure compliant, high-quality submissions and timely access to patients. The role also champions digital innovation within CMC regulatory operations and serves as a senior member of the Regulatory Affairs CMC Leadership Team. Responsibilities
Lead a small team of CMC regulatory scientists responsible for new modalities and traditional solid-oral small molecules, including pre-approval regulatory strategy and submissions (global clinical and marketing applications such as IND, CTA, NDA, and MAA) and limited CMC post-approval changes. Monitor regulatory developments with industry and agency connections and drive innovative regulatory approaches globally in partnership with Regulatory Affairs Global Regulatory Policy and External Advocacy teams. Act as CMC strategy lead for digital initiatives impacting the CMC Regulatory space, including internal and external digital efforts (e.g., generative AI authoring, Accumulus, SPQS, Digital CMC). Represent CMC Regulatory Affairs in executive forums, driving development and implementation of CMC regulatory strategy and plans for assigned projects/products. Communicate CMC regulatory strategy, risk, mitigation, and plans to Regulatory Affairs, R&D, Manufacturing and GHH management, product development teams, and executives. Establish strong cross-functional relationships with key stakeholders, customers, and external organizations. Perform risk assessments for strategic regulatory CMC decisions, approving appropriate risk levels and mitigations for significant issues. Ensure regulatory requirements are met and systems are used to maintain scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with Health Authorities. Evaluate business challenges of products/programs within the franchise and collaborate to develop new and improved solutions. Define resource requirements and allocate them to meet the profit plan, partnering with Manufacturing, R&D, and GHH Sales & Marketing to prioritize work and drive cross-divisional decisions. Education
Advanced scientific degree (MS or PhD) in Biology, Chemistry, Pharmacy, Engineering or related area with minimum 12 years’ experience in the pharmaceutical industry. Required Experience And Skills
Minimum 10 years’ experience in Regulatory CMC leading global programs with focus on respiratory/inhalation, peptide, ADCs, and traditional solid-oral small molecules, including pre-approval regulatory work (IND, CTA, NDA, MAA) and limited CMC post-approval changes. Minimum 7 years of significant People Management / Leadership experience with a track record of developing talent. Recognized as a leader with broad expertise in CMC regulatory strategy and dossier management across product development, registration, and lifecycle management. Strong track record of engagement and presenting/influencing at industry/agency meetings and conferences. Direct involvement in industry efforts on digital regulatory initiatives. Ability to anticipate and influence across divisions and external environment to minimize regulatory risk. Demonstrated ability to recruit, train and develop staff and drive continuous improvement. Flexibility to operate in a matrix-managed environment and support staff accordingly. Travel: 10% Required Skills
Key competencies:
Antibody Drug Conjugates (ADC), Biochemistry, Regulatory Strategy Development, Regulatory Compliance, Risk Analysis, eCTD, Digital Regulatory Innovation, Cross-Cultural Awareness, Leadership, Mentoring, Stakeholder Management, Regulatory Communications, Manufacturing Compliance, Documentation Standards. Preferred/Additional Information
U.S. Hybrid Work Model applies; salary range and bonus eligibility are per company policy. Travel 10%. No visa sponsorship. Equal employment opportunity statements apply. Applicants for California, Colorado and other states should review state-specific rights. Specific benefits and compensation details are provided on the Merck careers site.
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Executive Director, Regulatory CMC Small Molecule New Products – Merck, Rahway, NJ Role location: Rahway, NJ. This role leads the CMC regulatory strategy for pre-approval and lifecycle management of small molecule and new modalities, including respiratory/inhalation, peptide, and antibody-drug conjugates (ADCs). The position collaborates across Regulatory Affairs CMC, R&D, Manufacturing and Global Human Health to ensure compliant, high-quality submissions and timely access to patients. The role also champions digital innovation within CMC regulatory operations and serves as a senior member of the Regulatory Affairs CMC Leadership Team. Responsibilities
Lead a small team of CMC regulatory scientists responsible for new modalities and traditional solid-oral small molecules, including pre-approval regulatory strategy and submissions (global clinical and marketing applications such as IND, CTA, NDA, and MAA) and limited CMC post-approval changes. Monitor regulatory developments with industry and agency connections and drive innovative regulatory approaches globally in partnership with Regulatory Affairs Global Regulatory Policy and External Advocacy teams. Act as CMC strategy lead for digital initiatives impacting the CMC Regulatory space, including internal and external digital efforts (e.g., generative AI authoring, Accumulus, SPQS, Digital CMC). Represent CMC Regulatory Affairs in executive forums, driving development and implementation of CMC regulatory strategy and plans for assigned projects/products. Communicate CMC regulatory strategy, risk, mitigation, and plans to Regulatory Affairs, R&D, Manufacturing and GHH management, product development teams, and executives. Establish strong cross-functional relationships with key stakeholders, customers, and external organizations. Perform risk assessments for strategic regulatory CMC decisions, approving appropriate risk levels and mitigations for significant issues. Ensure regulatory requirements are met and systems are used to maintain scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with Health Authorities. Evaluate business challenges of products/programs within the franchise and collaborate to develop new and improved solutions. Define resource requirements and allocate them to meet the profit plan, partnering with Manufacturing, R&D, and GHH Sales & Marketing to prioritize work and drive cross-divisional decisions. Education
Advanced scientific degree (MS or PhD) in Biology, Chemistry, Pharmacy, Engineering or related area with minimum 12 years’ experience in the pharmaceutical industry. Required Experience And Skills
Minimum 10 years’ experience in Regulatory CMC leading global programs with focus on respiratory/inhalation, peptide, ADCs, and traditional solid-oral small molecules, including pre-approval regulatory work (IND, CTA, NDA, MAA) and limited CMC post-approval changes. Minimum 7 years of significant People Management / Leadership experience with a track record of developing talent. Recognized as a leader with broad expertise in CMC regulatory strategy and dossier management across product development, registration, and lifecycle management. Strong track record of engagement and presenting/influencing at industry/agency meetings and conferences. Direct involvement in industry efforts on digital regulatory initiatives. Ability to anticipate and influence across divisions and external environment to minimize regulatory risk. Demonstrated ability to recruit, train and develop staff and drive continuous improvement. Flexibility to operate in a matrix-managed environment and support staff accordingly. Travel: 10% Required Skills
Key competencies:
Antibody Drug Conjugates (ADC), Biochemistry, Regulatory Strategy Development, Regulatory Compliance, Risk Analysis, eCTD, Digital Regulatory Innovation, Cross-Cultural Awareness, Leadership, Mentoring, Stakeholder Management, Regulatory Communications, Manufacturing Compliance, Documentation Standards. Preferred/Additional Information
U.S. Hybrid Work Model applies; salary range and bonus eligibility are per company policy. Travel 10%. No visa sponsorship. Equal employment opportunity statements apply. Applicants for California, Colorado and other states should review state-specific rights. Specific benefits and compensation details are provided on the Merck careers site.
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