The Executive Director of CMC Regulatory Sciences (CMC RS) leads the function and reports to the Head of Analytical Operations & Information Systems (AOIS) and is a member of the Analytical Operations (AO) extended leadership team. The Executive Director works closely with other Pharmaceutical Development & Manufacturing (PDM) functional groups to plan and author high quality regulatory submissions to world-wide health authorities. This role manages regulatory submissions that meet aggressive timelines, with content that is consistent across development programs, and established on a sound, scientific basis. The Executive Director develops regulatory submission strategies to manage a product through its life cycle and sunset. The group is responsible for small molecule drug development, biologics and medical devices in the company's pipeline.
The Executive Director is focused on organizational excellence and develops staff with skills in operational, technical and regulatory leadership to make good, timely decisions and achieve impactful outcomes. This role and group represent CMC RS in PDM sub-teams, with emphasis on late-stage development, commercial regulatory submission strategy and pediatric development programs. This role establishes career paths for employee development and executes in alignment with corporate priorities for inclusion and diversity. In addition, this role is specifically accountable for the CMC registration lifecycle for Rest of World (RoW) countries, Medicines Patent Pool, generic partners, voluntary licenses and establishes the framework for technology transfer.
Essential Duties of the Function:
Responsible for the preparation and oversight of technically complex clinical and commercial regulatory CMC submissions, taking into consideration ICH guidance, local statutory requirements, scientific principles and business policies and procedures.
Establish quality specifications for drug substance and products based on scientific knowledge, control strategies, and regulatory compliance.
Incorporate strategic regulatory guidance to the content of regulatory submissions and respond to health authority requests for information.
Incorporate operational design ranges to test methods to maximize regulatory flexibility in product registration life cycle management.
Responsible for CMC content of Rest of World (RoW) marketing applications, and address requests for information.
Prepare technology transfer packages and provide technical support to generic partners.
Apply up-to-date knowledge of regulatory compliance requirements and communicate changes in regulatory information to project teams and management.
Establish analytical control strategies and manage product risks aligned with technical requirements described in ICH Q8-Q12.
Manage the change control for AO-related post approval changes.
Provide justification and action limit assessment for drug product shelf-life extensions. In partnership with Data Sciences, apply statistical analytics and trend analysis to support retest/shelf-life extensions.
Manage AO controlled documents associated with commercial regulatory applications and commercial manufacturing.
Initiate and/or contribute to process improvements, which have a significant impact on the overall efficiency of the regulatory submission process.
Generally, accomplish results through lower management levels. Determine and establish organizational structures and supervisory relationships that are subject to upper management approval.
Knowledge and Skills:
BS, MS, or PhD with focus on Analytical Chemistry or related field is required, with 20+ years of experience in Analytical Chemistry/Regulatory Affairs.
Specific experience in analytical method life cycle management, technology transfer, drug stability, sterility assurance, dissolution science and authoring of technical CMC content for regulatory submission such as NDA, BLA, and MAA applications.
Proven ability to establish and lead high performing teams.
Excellent verbal and written communication skills, and interpersonal skills are required.
Strong business acumen and experience with CMC requirements for drug development of new molecular entities, with specific experience in regulatory submissions for marketing authorization.
Recognized as a knowledgeable resource for regulatory advice and strategy, and able to collaborate with CMC sub-teams in the preparation of complex submissions.
Must have in-depth knowledge of regulatory requirements, including ICH requirements and local requirements, and understanding of current global and regional trends in regulatory affairs.
Must be capable of developing and implementing regulatory submission strategy. Well versed in analytical control strategies for small molecules, biologics, parenteral drugs, medical devices and combination products