Beschreibung

You will drive the global CMC strategy, from drafting complex regulatory submissions to negotiating with Health Authorities to ensure the seamless approval of vital medical assets.

Anforderungen

• •BSc in Life Science or Advanced Degree
• •7-10 years experience in CMC Regulatory Affairs
• •Expertise in global regulatory CMC requirements
• •Experience in product registrations and lifecycle management
• •Beneficial experience in clinical phase CMC development
• •Ability to manage Health Authority interactions
• •Knowledge of global regulatory guidelines
• •Fluency in English
• •Effective verbal and written communication skills
• •High computer literacy in Office software
• •Preferred experience with Veeva
• •Adherence to Sobi core values
• •Attention to detail and problem-solving abilities
• •Good judgement in communicating risks
• •Ability to represent Regulatory CMC in teams
• •Ability to develop solutions for complex issues
• •Independent motivation and detail-orientation

Aufgaben

• •Develop global regulatory CMC strategies
• •Ensure rapid approval of marketing applications
• •Write and compile CMC submission sections
• •Lead SME teams on eCTD Quality modules
• •Review dossier data to identify risks
• •Collaborate with stakeholders on risk mitigation
• •Manage Health Authority inquiries effectively
• •Negotiate with Health Authorities on CMC issues
• •Maintain project plans for CMC submissions
• •Evaluate manufacturing changes for global impact
• •Provide guidance on ICH and FDA guidelines
• •Align strategies with contract manufacturing partners
• •Represent CMC on cross-functional project teams
• •Store regulatory information in Veeva systems

Tools & Technologien

Benefits