Regulatory Scientist CMC

il y a 4 semaines

Paris, Île-de-France VCLS Temps plein
Associate Director, Regulatory Science CMC

We are seeking an experienced Associate Director to join 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:
  1. CMC Development Support: Oversee CMC deliverables for clients in the US and EU, ensuring compliance with regulatory requirements.
  2. Regulatory Strategy: Provide strategic guidance on CMC development pathways, regulatory submissions, and risk assessment.
  3. Due Diligence: Conduct thorough gap analyses and due diligence assessments to identify potential risks and opportunities.
  4. Client Engagement: Collaborate with clients and internal project teams to effectively address their CMC needs.
  5. Regulatory Intelligence: Stay updated on the latest EU/US regulatory guidelines and trends to inform strategic decision-making.
  6. Operational Efficiency: Contribute to process improvements and optimization within CMC operations.
Product Focus:
  1. Biological Products: Primarily focus on antibodies, ADCs, proteins, and vaccines.
  2. Small Chemical Entities: Experience with small molecules is a plus.
  3. Combination Products: Knowledge of device section requirements for CMC combination products is beneficial.
Requirements:

At least 5 years of experience in the pharmaceutical industry or CMC consulting, with experience in regulatory submissions, agency interactions, and consulting or CRO environments.

Strong analytical and problem-solving abilities, excellent communication skills, and the capability to work collaboratively across multidisciplinary teams.

Fluency in English; additional language skills are a plus.

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