Senior Small Molecule CMC Lead
il y a 6 jours
This is a senior leadership role responsible for delivering post-approval activities for commercial small molecule products across global markets.
Key Responsibilities:- Develop and execute a comprehensive CMC Regulatory strategy to ensure timely advice to the technical team.
- Manage all regulatory aspects related to Change Control requests, ensuring seamless delivery of necessary documents.
- Lead project management activities to support CMC post-approval work, guaranteeing quality and timeliness.
- Liaise with Local Affiliates to develop efficient regulatory strategies, aligning with country requirements and agreed timelines.
- Represent CMC Regulatory in relevant governance meetings and activities.
- Prepare and compile regulatory documents to support submissions, adhering to country-specific requirements.
- Generate gap analysis and risk management support for each submission as needed.
- Identify rate-limiting deliverables and interdependencies across technical and regulatory aspects.
- Provide regular status updates to stakeholders and manage documents through the document management system.
We seek an individual with extensive experience in CMC technical roles, specifically lifecycle management of small molecule products. Key qualifications include:
- At least 10 years of experience in CMC technical roles, with 5+ years in lifecycle management of small molecules.
- Proven track record of effective stakeholder management throughout asset lifecycles.
- Organized and independent, with ability to manage multiple activities concurrently.
- Degree in Pharmacy or relevant science/technical subject.
- Fluency in English.
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