CMC Regulatory Manager (f/m/x)応募後で応募 求人ID R0035482 掲載日 06/15/2021 Location:Vienna, Austria
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a CMC Regulatory Manager in our Vienna office.
Here, you will be a vital contributor to our inspiring, bold mission.
Your tasks within this position:
Supports the development and execution of regulatory CMC investigational, registration and post-approval strategies for assigned products. Supports Regulatory, Pharmaceutical Development, and Commercial project teams for assigned products throughout clinical development and commercial lifecycle
Develops a solid understanding of global RA CMC regulations and guidelines, and participates in the development of strategies to enhance probability of regulatory success or enhancing regulatory compliance
Interacts and effectively communicates with other internal and external colleagues
Executes and manages regulatory submissions for assigned projects
Helps define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements.
With supervision, participates in Health Authority interactions and supports preparation activities for meetings with Health Authorities on CMC related matters
Ensures line management is apprised of developments that may impact regulatory success, communicating in a professional and timely manner
Evaluates change proposals for global regulatory impact with supervision and helps plan variations and amendments
The skills you need:
BS/BA Degree in Scientific Discipline, Advanced Degree preferred
4+ years pharmaceutical Regulatory CMC experience in a supportive role, or equivalent industry experience (e.g. Pharmaceutical development, Analytical development, Production. QA)
Ability to understand, apply, and articulate regulatory requirements for global drug development and post-market support initiatives required
Demonstrates attention to detail and problem-solving abilities
Exercises appropriate judgement when working with project teams
Exercises good judgement in elevating and communicating actual or potential issues to line management
Excellent written and oral communication skills required