Regulatory Scientist CMC-Biologics
il y a 2 semaines
As an Associate Director, you will play a pivotal role in guiding clients through the complex landscape of CMC development and regulatory compliance. You will provide expert consulting services, including strategic advice, gap analyses, and due diligence, to ensure the successful development and commercialization of their biological products.
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.
Join our team and make a significant impact on the development of innovative biological products.
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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