Edwin E. Rodriguez Schroeder Email & Phone Number

United States

Wilmingto, DE

From September 2020 to present completed several projects related to Data Integrity- BLA submission review, Quality Management System verification and optimization, FDA 483 responses/action plan implementation. In addition, working as a VP of Quality Operations/Regulatory Affairs for the implementation of site Quality Management System and Regulatory.

China

Site committee executive member. Responsible for leading the site quality operations and regulatory compliance: - Implemented the Regulatory Affairs structure, policies and procedures.- Ensure the organization is running smoothly and in full compliance with the USA, China, Germany, and European cGMP requirements. - Host in conjunction with company CEO the.

Glendale Heights

Serve as the primary corporate liaison / contact with domestic and/or international regulatory agencies (e.g., FDA Investigators, Notified Body Auditors) regarding the Medefil’s quality management system and regulatory submissions (510(k), ANDA, NDA [(505(b) (2)], sNDA. Responsible for maintaining Licenses for Medical devices –Canada/Europe, and Canada.

San Juan, Puerto Rico

Responsible to support drug product development and documentation review for regulatory submissions to USA and Europe. Facility location was in Campinas, Brazil with an office in San Juan, Puerto Rico.

Manati, Puerto Rico

Provide a wide variety of professional services to the Drug and Medical Devices industries. Some services provided: quality system review and optimization, regulatory audits, training, Federal/local licensing and registrations, and liaison between industry and FDA and local Department of Health.

Manati, P.R.

Manage the Regulatory Compliances activities such as: Federal/Local state licenses, Stability programs, Complaint handling/Investigations, Internal/External audit programs (Supplier Management Programs), implementation of product specifications, and the managing of regulatory inspections from different regulatory organizations such as FDA, Canadian.

Gurabo, P.R.

Associate Director, Quality Assurance/ Quality Engineering Plan, organize and direct the Regulatory Compliances, Quality Assurance and Quality Engineering activities such as: Computer Software Validation, internal/external audit programs, implementation of product specifications, Supplier Management Programs, and the managing of regulatory inspections such.

Guayama, P.R.

Plan, organize and direct all activities related to the QA department for Active Product Ingredients (APIs) and finished pharmaceutical products. Coordinate, and maintain the quality systems to support operations. Management of all coordination related to the sampling, testing and release of incoming raw materials, components, and finished product. Also.

Manati, P.R.

Regulatory Compliance ManagerReport directly to the legal department. Responsible for management of DEA/FDA compliance activities, at three facilities: Aguadilla, Manatí, and Caguas. Liaison between the DEA/FDA/Local Department of Health at the three facilities in Puerto Rico.Compliance ManagerManagement of the regulatory compliance offices in Puerto Rico.

Camden, N.J.

Covered a full range of FDA regulated industries including, but not limited to, Drugs (sterile/non sterile), Medical Devices (sterile/non sterile), Medicinal gases, and biologics. Collected evidence and prepared narrative reports of conditions observed during inspections for regulatory sanctions.

Bachelor Of Science (B.S.), Biology/Biological Sciences, General

Bachelor Of Applied Science (B.A.Sc.)