Global Regulatory Lead CMC

IntelStack; Deutschland; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

IntelStack in Germany seeks a Regulatory CMC Specialist to evaluate change controls, define regulatory strategy (RAAT), and ensure compliant documentation for EU submissions.

You will review and dispatch final packages to Local Regulatory Affairs, monitor timely variations and renewals, coordinate responses to health authority questions, and oversee cross-functional planning for product changes.

Qualifikationen

• Experience conducting regulatory evaluation of change controls for CMC documentation.
• Ability to develop regulatory strategy and conduct Regulatory Impact Assessments (RAAT).
• Proven track record in coordinating submission packages and regulatory responses.

Aufgaben

• Provide regulatory evaluation of change control including data/documentation requirements and RAAT strategy.
• Review documentation and dispatch final submission package to Local Regulatory Affairs.
• Monitor timely submission and approval of variation packages, renewals, and CMC commitments; coordinate responses to health authority questions.
• Oversee overall planning of all CMC regulatory changes per product with cross-functional teams.
• Provide regular progress reports and updates.

Kenntnisse

Regulatory evaluation

Change control

Cross-functional collaboration

Regulatory strategy

Submission management

Jobbeschreibung

Keywords: Change control Assessment/Evaluation, Regulatory requirements, variation classification, Regulatory CMC Strategies, Lifecycle management of submissions, Compile, review, and dispatch overall submission package

Market Experience: EU, APAC, China, Japan

JD for GRL CMC-

• Provide of regulatory evaluation of change control (data/documentation requirements and regulatory strategy (RAAT (Regulatory Impact Assessment)))
• Review documentation and dispatch final documentation package to Local Regulatory Affairs
• Monitor timely submission and approval of variation packages, renewals and CMC commitment, Manage and coordinate responses to health authority questions
• Overall planning of all CMC regulatory changes per product together with relevant interfaces, G CMC RA in cross-functional teams
• Provide regular progress reports and updates

Provide regulatory requirements and regulatory strategy for post approval changes or tasks in Regulatory processes with special emphasis on CMC aspects