Associate Director of Regulatory Medical Writing in California

Aramis Frost is partnering with a leading Biotech specializing in Oncology to find an Associate Director of Regulatory Medical Writing. In this pivotal role, you will oversee the regulatory writing strategy and contribute significantly to the development of cutting-edge oncology therapies. You will work closely with cross-functional teams to ensure timely and accurate submissions to regulatory authorities.

Key Responsibilities

• Lead the preparation and review of complex regulatory documents, including INDs, NDAs, and clinical study reports.
• Collaborate with project teams to develop writing strategies that align with clinical and regulatory objectives.
• Mentor and guide team members in best practices for regulatory writing and compliance.
• Maintain up-to-date knowledge of regulatory guidelines and industry trends specific to oncology.
• Engage with regulatory agencies as needed to facilitate the submission process.
...