Global CMC Regulatory Strategy Lead

GlaxoSmithKline; Upper Providence (Delaware County); In loco; USD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

GlaxoSmithKline is seeking a CMC Regulatory Affairs professional to lead global regulatory activities from early development through lifecycle management. You will shape strategy, ensure compliance, and collaborate with regulatory, development, quality and manufacturing teams to facilitate timely submissions.

You will influence cross-functional projects, drive continuous improvement, and provide SME guidance for major inspections and regulatory interactions.

Competenze

• In-depth knowledge of worldwide CMC regulatory requirements and successful dossier delivery across development stages.
• Experience in regulatory submission preparation from IND/IMPD through NDA/BLA/MAA and lifecycle management.
• Ability to interpret regulations, guidelines, procedures and policies for development, registration and manufacture.

Mansioni

• Own global CMC regulatory activities for assigned projects and adapt to changing priorities.
• Develop CMC submission strategy for early phase submissions through marketing applications and lifecycle management.
• Advise teams on CMC regulatory requirements to expedite submissions and approvals.

Conoscenze

Communication

Digital Fluency

Influencing Without Authority

Learning Agility

Pharmaceutical Regulatory Compliance

Problem Solving

Regulatory Strategies

Strategic Leadership

Formazione

BSc Life sciences or related scientific discipline (or PhD)

Descrizione del lavoro

GlaxoSmithKline is seeking a CMC Regulatory Affairs professional to lead global regulatory activities from early development through lifecycle management. You will shape strategy, ensure compliance, and collaborate with regulatory, development, quality and manufacturing teams to facilitate timely submissions.

You will influence cross-functional projects, drive continuous improvement, and provide SME guidance for major inspections and regulatory interactions.