Maryland Licensed Regulatory Affairs Manager

A company is looking for a Manager, Regulatory Affairs, Pharmacovigilance. Key Responsibilities Oversee and execute all regulatory submissions of pharmacovigilance documents to global regulators Coordinate with functional groups to prepare necessary documentation for regulatory submissions Manage regulatory health authority commitments and timelines in collaboration with stakeholders Required Qualifications Bachelor's degree in a scientific/medical field; advanced degree preferred Minimum of 5 years in the biotechnology industry, with at least 2 years in Regulatory Affairs focused on pharmacovigilance Demonstrated knowledge of pharmacovigilance regulations and processes Strong understanding of ICH, GCP, and global regulatory requirements in the pharmacovigilance setting Experience managing individual case and aggregate safety reports

Apr 9, 2025 - 21:50

A company is looking for a Manager, Regulatory Affairs, Pharmacovigilance. Key Responsibilities Oversee and execute all regulatory submissions of pharmacovigilance documents to global regulators Coordinate with functional groups to prepare necessary documentation for regulatory submissions Manage regulatory health authority commitments and timelines in collaboration with stakeholders Required Qualifications Bachelor's degree in a scientific/medical field; advanced degree preferred Minimum of 5 years in the biotechnology industry, with at least 2 years in Regulatory Affairs focused on pharmacovigilance Demonstrated knowledge of pharmacovigilance regulations and processes Strong understanding of ICH, GCP, and global regulatory requirements in the pharmacovigilance setting Experience managing individual case and aggregate safety reports