CMC Regulatory Strategy Manager

GlaxoSmithKline; Philadelphia (Philadelphia County); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive program

Job summary

GlaxoSmithKline is seeking a senior CMC Regulatory professional to lead global regulatory activities for assigned lifecycle stages of GSK products. You will drive CMC submission strategies across IND/IMPD through NDA/BLA and lifecycle management, coordinating with development, QA, and manufacturing to align with evolving regulatory standards.

The role requires deep knowledge of worldwide CMC requirements, strong project management, and the ability to influence cross-functional teams to deliver

Qualifications

• BSc Life sciences or related scientific discipline (or PhD).
• Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
• Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise.
• Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
• Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
• Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
• Has broadened own knowledge base across regulatory functions to understand wider implications of emerging issues across projects.
• Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings.
• Strong interpersonal, presentation and communication skills with established internal networks.

Responsibilities

• Be responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
• Be responsible for CMC strategy development, with managerial support, for CMC submission documents from early phase clinical submissions through to marketing applications and early lifecycle management activities.
• Understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of medicinal products.
• Ensure all appropriate CMC regulatory aspects for clinical trials/product release are in place to avoid clinical holds and ensure continuity of market supply.
• Work in cross-functional matrix project teams including regulatory, development, quality and manufacturing to define regulatory CMC filing strategy.
• Maintain high quality standards and seek continuous improvement in responding to evolving regulatory environment.
• Ensure regulatory compliance is maintained and share best-practices within CMC Regulatory teams and other impacted functions.
• Engage in CMC Subject Matter Expert activities internally for compliance, harmonisation and efficiency.
• Deliver CMC regulatory strategy to support major inspections with managerial support.
• Developing experience in major filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/pre-Phase 3).

Skills

Communication

Digital Fluency

Influencing Without Authority

Learning Agility

Pharmaceutical Regulatory Compliance

Problem Solving

Regulatory Strategies

Strategic Leadership

Education

BSc Life sciences

PhD

Job description

GlaxoSmithKline is seeking a senior CMC Regulatory professional to lead global regulatory activities for assigned lifecycle stages of GSK products. You will drive CMC submission strategies across IND/IMPD through NDA/BLA and lifecycle management, coordinating with development, QA, and manufacturing to align with evolving regulatory standards.

The role requires deep knowledge of worldwide CMC requirements, strong project management, and the ability to influence cross-functional teams to deliver