Global Regulatory CMC, Early Development Lead

Job Description

What You’ll Do

People management:

• Accountable for line management and development of direct reports.
• Developing soft and technical skills, ensuring coaching and mentoring of the assigned team, and conduct performance assessment.
• Managing team resources efficiently – ensure proper resources allocation, enhance knowledge sharing and support the team to prioritize activities.
• 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 interaction and influence).
• Participate in technical and soft skill development, coaching, and performance feedback of the people working in Global RegCMC community, if requested by their management.
• As part of Global RegCMC, participate in the development of working processes and activities to increase the efficiency within Global RegCMC function.

Product / Project Strategy:

• Designate adequate regulatory CMC resource to deliver the projects / products objectives as agreed and prioritized,
• Accountable to communicate and obtain, if needed, Global RegCMC Modality Head, Global RegCMC Head endorsement of strategies developed by the Global RegCMC teams.
• Accountable for the team’s effective communication and interactions with Health Authorities.
• Accountable for all team members’ deliverables.
• Accountable for consistent strategies and quality of regulatory CMC deliverables for early development programs
• While being assigned as CMC GRL for specific early development programs, takes accountability for strategy, planning, definition of content, preparation, review and approval of global regulatory CMC submissions and responses to Health Authority questions, ensures effective communication of CMC regulatory strategy, risks, and overall plans to leadership and teams.
• Ethically interacts with multiple international, cross-functional departments, industry peers and health authority contacts at all levels.
• Interacts with key stakeholders both internally and externally, including subject matter experts, partners and regulatory agency personnel.

Qualifications

The Global Regulatory CMC Development Lead also acts as Global Reg CMC Lead for assigned programs as needed.

This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, regulatory CMC knowledge and interpersonal skills are required.

· Minimum 10+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity with preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field

· Minimum BS in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.

· Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) 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

· Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.

· Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.

· Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.

· Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.

· Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities.

Additional Information

About This Role

The Global Regulatory CMC Early Development Lead is responsible for the line management of the team members with responsibilities for early stage of development activities for the small molecules portfolio. The Global Regulatory CMC Development Lead assigns projects to the team members, supports the team members in setting regulatory CMC strategies and their daily work. Ensures coaching is provided as needed and the talents of the team members are enhanced through the assigned projects and through development opportunities.