Michael Mullane Email & Phone Number

Long Beach, Ca, Us

Irvine, California, United States

Irvine, California, United States

Madison, New Jersey

Bensalem, Pennsylvania

- Managed FDA requests for Complete and Information Responses by coordinating with cross functional groups while observing aggressive timelines- Managed timelines, interactions and regulatory-related study activities with CROs- Maintained current knowledge of regulatory standards- Led work plans and provided direction to lower-level associates while maintaining the responsibilities described below of Senior Associate- Managed the submission of a product for approval in EU - Lead meetings with external vendor to discuss EU strategy and develop timelines - Coordinated internal cross functional teams to meet deadlines - Reviewed CMC, clinical, non-clinical and labeling documents to ensure they complied with EU regulations

Bensalem, Pennsylvania

- Led post-marketed regulatory activities for approved products including submission of CMC and labeling supplements and annual reports- Managed the preparation and submission of regulatory documents in support of ANDAs, DMFs, amendments and supplements in eCTD format- Managed the change control process from tracking in-coming changes and providing assessment of the changes based on FDA guidances- Coordinated and consulted with other departments on the content, review and assembly of regulatory documentation for submission- Maintained current knowledge of regulatory standards to proved expertise and guidance in interpreting governmental regulations and agency guidelines to ensure adequate and complete submissions- Keep abreast of paragraph IV certifications, patent and exclusivity status and labeling updates- Managed the intake and handling of pharmacovigilance activities (DPI, ADE, Complaints)

- Coach and execute counseling discussions with students and technicians;- Ensure accurate, safe, and timely prescriptions to patients;- Coordinate/Implement the training and development of technicians, interns and pharmacists;- Administer immunizations;- Maintain a perpetual schedule;- Maintain inventory levels by following defined ordering practices for warehouses and approved outside vendors (expired med, TIL, BOH);- Provide counseling to patients/clients in person and on phone;- Verify prescriptions (Assure the correct patient, drug, dosage form, quantity, day supply, number of refills, doctor, and labeling);- Oversee the preparation and dispensing of prescription medications to patients or medical practitioners;- Follow established policies, procedures and objectives, continuous quality improvement objectives, and safety, environmental and/or infection control standards;- Oversee the preparations of all necessary records on prescriptions and other pharmacy related records; - Utilize/maintain the ScriptPro robotic dispensing system.