Alejandra C. Ryder, RPh, MBA

Licenses, Education and Professional Memberships

****-******* ********** ********** ** New Jersey

****-**** ***, ******* *********** State University

****-**** **, Pharmacy, Rutgers, the State University of New Jersey

2014-Present Regulatory Affairs Professional Society (RAPS) member

Experience

Novartis Consumer Health, Parsippany, NJ

Manager, Regulatory Affairs 8/2006-3/2007

. Worked closely with marketing and legal departments in order to ensure

optimal positioning of OTC Cough and Cold medications' labeling and

advertising for compliance with the OTC Drug Monograph regulations.

. Managed responses to FDA inquiries regarding Nicotine Patch NDA.

. Prepared Annual Reports for Lamisil AT, Lamisil Solution.

. Managed the compilation of the briefing book for a meeting with the FDA

regarding a Non-Steroidal Anti Inflammatory Drug. This process involved

close collaboration with QA, Formulation and Marketing departments.

GeneraMedics Inc., Liberty Corner, NJ

Manager, Regulatory Affairs 5/2005-8/2006

. Collaborated closely with contract manufacturers in order to compile and

submit ANDAs for sterile products using Common Technical Document (CTD)

format.

. Verified tagging of package inserts for electronic submission to FDA.

Generated label templates for submission to FDA.

Akros Pharma Inc., Princeton, NJ

Manager, Regulatory Affairs 2/2000-5/2005

. Interacted with Manufacturing, Packaging, Analytical and Labeling

departments at Japan Tobacco (parent company) to prepare the Chemistry &

Manufacturing Controls (CMC) section of INDs.

. Developed CMC IND templates using CTD format.

. Managed the compilation of INDs.

. Prepared CMC, Clinical and Non-Clinical IND Amendments for Anti-Viral

compounds.

. Coordinated reporting of Serious Adverse Event Reports to regulatory

authorities in US, Europe and Japan.

. Provided Regulatory approval for all labeling for clinical trial

materials.

Akros Pharma Inc., Princeton, NJ (ctd.)

Electronic Document Management System Administrator 5/2001-5/2005

. Liaison between Qumas and Akros Personnel to identify the document

requirements of each department within Akros.

. Acted as Akros Development Team Leader for the design, writing of

specifications, testing, and implementation of Qumas System at Akros.

. Trained all employees on the use of the system.

. Used, maintained and managed the system.

Boehringer Inlelheim, Ridgefield, CT

Clinical Drug Coordinator, Materials Management 10/1996-5/1999

. Represented Pharmaceutics Department in project team and project sub-team

meetings.

. Developed Materials Management Budget for assigned projects.

. Coordinated the procurement, release, packaging, labeling and shipment of

all materials necessary to run clinical trials for five to seven drug

products each of which had one to five active clinical protocols.

Schein Pharmaceuticals, Brewster, NY

Drug Information Specialist 8/1995-10/1996

. Provided information regarding drug therapies to health care

professionals.

. Procured information on adverse reactions. Compiled and submitted

MedWatch Forms (Form 3500).

. Reviewed Quality Assurance records in response to product quality issues,

and met with department heads to discuss changes in procedures which

could improve product line and limit complaints.

Languages

Spanish - Native bilingual fluency

French - Conversational fluency

Volunteer work

Member of the International MOMs Club 2007-present

Treasurer 2011-present

Nut and Magazine Manager - Girl Scout Heart of NJ Troop 80689 2011-

present

Clothing Drive Coordinator - Readington Township School Association 2013-

present

Contact this candidate