What You’ll Do

• Accountable for line management and development of direct reports.
• Ensure the development of the Global RegCMC team members by identifying challenging objectives and enhance team visibility as key experts in submissions excellence (including Health Authority (HA) interaction and influence).
• As part of Global RegCMC, participate in the development of working processes and activities to increase the efficiency within Global RegCMC function.
• Accountable for strategy, planning, definition of content, preparation, review and approval of Global RegCMC submissions and responses to HA questions.
• Ensures that the Global RegCMC strategy for assigned products are consistent with the teams and business goals, missions and objectives and meet HA requirements.
• Identifies supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
• Accountable review and approval of CMC submissions and responses to HA questions in line with agreed global regulatory strategy, and within agreed timelines.
• Leads cross-functional teams responsible for the preparation of submissions and responses to HA CMC questions for assigned projects/products.
• Ensures effective communication of CMC regulatory strategy, risks, and overall plans to leadership and teams and key stakeholders.
• Accountable for all RegCMC related interactions, resolution of CMC issues and negotiation of CMC approvals with HAs in all regions.

Required Skills

• Minimum Bachelors Degree (preferably in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science)
• Minimum 12-15 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 8 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
• Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities
• Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions.
• Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics.
• Knowledge of global guidance, regulations and ICH/GMP requirements.
• Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure.

Preferred

Graduate degree is preferred

About this role

The Head Global Regulatory CMC (RegCMC) Lead is responsible for line management, with responsibilities for commercial activities for the biologics products portfolio. The Head Global RegCMC Lead assigns activities to the team members, supports setting regulatory CMC strategies, and provides coaching and development.

Who You Are

This candidate must have proven leadership and abilities to work cross-functionally globally.  Strong communication, RegCMC knowledge and interpersonal skills are required.  This role is responsible for defining RegCMC strategy, planning and the preparation of global RegCMC submissions to achieve timely approvals of initial marketing authorization applications and post-approval lifecycle changes with a focus on commercial biologic programs.  Responsibilities include actively leading the development and implementation of RegCMC strategy for specific biologics programs, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing RegCMC leadership.