Associate Director of Regulatory Affairs

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

May 22, 2025 - 01:30

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