Director of Regulatory Science
il y a 1 mois
VCLS is seeking an experienced Associate Director to lead our Regulatory Science CMC team. As a key member of our team, you will play a pivotal role in guiding clients through the complex landscape of CMC development and regulatory compliance.
Key Responsibilities:
- CMC Development Support: Oversee CMC deliverables for clients in the US and EU, ensuring compliance with regulatory requirements.
- Regulatory Strategy: Provide strategic guidance on CMC 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 CMC needs.
- Regulatory Intelligence: Stay updated on the latest EU/US regulatory guidelines and trends to inform strategic decision-making.
- Operational Efficiency: Contribute to process improvements and optimization within CMC operations.
Product Focus:
- Biological Products: Primarily focus on antibodies, ADCs, proteins, and vaccines.
- Small Chemical Entities: Experience with small molecules is a plus.
- Combination Products: Knowledge of device section requirements for CMC combination products is beneficial.
Requirements:
Experience: At least 5 years in the pharmaceutical industry or CMC consulting, with experience in regulatory submissions, agency interactions, and consulting or CRO environments.
Skills: Strong analytical and problem-solving abilities, excellent communication skills, and the capability to work collaboratively across multidisciplinary teams.
Values: Commitment to our PIPE values—People, Innovation, Passion, and Excellence—demonstrating a proactive approach to personal and professional growth while fostering a positive team environment.
Languages: Fluency in English; additional language skills are a plus.
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