Associate Director of Regulatory Affairs

Job Summary

A company is looking for an Associate Director of Regulatory Affairs.

Key Responsibilities:

• Develop and implement regulatory strategies for clinical trials and marketing applications
• Prepare, review, and submit regulatory applications to health authorities for timely approvals
• Identify regulatory risks and develop strategies to mitigate them while collaborating with cross-functional teams

Required Qualifications:

• A minimum of a bachelor's degree with 6-8 years of experience in pharmaceutical regulatory affairs
• Proven track record of managing complex regulatory submissions and clinical trial applications
• Strong knowledge of global pharmaceutical regulations, including FDA and EMA requirements
• Proficiency in medical and technical writing for regulatory documents
• Experience with CMC regulatory, device, and/or diagnostic submissions is a plus