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 Affairs to include non-clinical/clinical plans review, follow ups and pre-IND activities.

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 Germany Inspection for the manufacturing license and manufacturing certification obtained.- Hosted ISO 90001 and obtained the ISO 90001 certification. - Received China approval as a manufacturer site.- Created and approved Quality and supplier agreements with suppliers and customers. - Responsible for managing the compliance of site validation programs, Media fills, and stability studies. - Met with several government offices such as CFDA and Local Development office to present projects and strategy planning on production.July 2014 to October 2018Quality Operations DirectorOncoGenerix, Co. Ltd. China Site committee executive member. Responsible for leading the site quality operations: - Implemented site Quality Assurance and quality Control structure, policies and procedures.- Ensure the organization is in full compliance with the USA, China, Germany, and European cGMP requirements. - Obtained CFDA re-certification as a manufacturer.- Create several manufacturing and warehousing procedures for managing the purchasing, receiving, and storage of materials. - Implemented all Incoming, In process, and batch record release systems - Implemented most of the site policies. - Implemented site Mission, Vision, and Quality statement.- Created the Site Master file in compliance with EU requirements.- Created the site Quality Manual. - Established initial system and communication with authorities related to managing spills, storage of toxic chemicals, and MSDS managing. - Created most of the site Human Resources procedures including the Employees Handbook.

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 DINs. ISO Management Representative, Host FDA, Canada Health, European Union, ISO audits. Manage, prepare, review, implement and maintain product technical files, ADE periodic reports, Annual Product Review, and Annual Product Reports. Oversee the Preparation and implement of the site Quality Manual updates, Monitor and control market for Post marketing evaluation and reporting, Customer Complaints Program, Medical Device Program, Device and Drug Reporting, Recalls, Maintain site Licenses / Registration, and product listing to USA, Canada, Europe and any other countries not part of the EU community. Manage, control, review, and monitor product labeling and advertising materials for compliance with US and international labeling regulations and maintain the Quality organization on any regulatory updates, guidelines and/or new/changes to official product testing monographs.Added responsibilities since November 2013Direct Reports: Director of QA, QA/QC Laboratories, R&D

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 Department of Health Agency (DHHS), European Agency for the Evaluation of Medicinal Products (EMEA), and Medicines Control Agency (MCA). Responsible for managing the regulatory documentation (Change Control, Chemical Manufacturing Controls- New Drug Application (CMC-NDA), FDA and European communications on Field Alerts and Recalls among other regulatory activities.

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 as FDA, DEA/Canadian DHHS, MCA, and EMEA for routine and Pre-approval (PAI) inspections. Also, responsible for supporting site projects for quality, cost reduction and cycle time improvement. Associate Director, Quality AssurancePlan, organize and direct all activities related to the Quality and regulatory compliance activities such as method transfer, new/transfer product technology, validation support, material/product review and release, complaint handling, stability programs, FDA/DEA activities and Annual Product Reviews.Quality Assurance ManagerPlan, organize and direct all activities related to the sampling, testing and release of incoming raw materials, components, and finished products. Responsible for the coordination, preparation, and presentation of annual product reviews. Implement and maintain the complaint handling system.

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 manage the stability testing activities, audit programs, complaint review, trending, and annual product reviews.

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 to support all internal/external-auditing activities for the DuPont sites. External auditing includes FDA/DEA, Canadian and European support. Responsible for keeping site management abreast of changes to the regulatory requirements. Coordinated the sNDA, NDA file transfer to 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.)