Senior Biologics Development Lead
il y a 7 jours
VCLS is seeking a highly experienced Senior Biologics Development Lead to oversee the development of biologics products. As a key member of our team, you will be responsible for guiding clients through the complex regulatory landscape of CMC development and ensuring compliance with EU and US regulations.
The ideal candidate will have at least 5 years of experience in the pharmaceutical industry or CMC consulting, with a strong background in regulatory submissions, agency interactions, and consulting or CRO environments.
Key responsibilities include:
- CMD development support: Oversee CMD deliverables for clients in the US and EU, ensuring compliance with regulatory requirements.
- Regulatory strategy: Provide strategic guidance on CMD development pathways, regulatory submissions, and risk assessment.
- Due diligence: Conduct thorough gap analyses and due diligence assessments to identify potential risks and opportunities.
- Client engagement: Collaborate with clients and internal project teams to effectively address their CMD needs.
- Regulatory intelligence: Stay updated on the latest EU/US regulatory guidelines and trends to inform strategic decision-making.
We offer a competitive salary of $120,000 - $160,000 per annum, depending on experience, plus benefits and opportunities for professional growth and development.
In this role, you will work closely with cross-functional teams to drive business results and contribute to process improvements within CMD operations.
Product focus includes biological products such as antibodies, ADCs, proteins, and vaccines, as well as small chemical entities and combination products.
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