Regulatory Affairs Project Management

CYNTHIA BEIDLER RN, BSN, CRA

West Point PA ***** 267-***-**** *********@*****.***

SR. SPECIALIST REGULATORY AFFAIRS, QUALITY & COMPLIANCE & PHARMACOVIGILANCE SAFETY ANALYST

Hands-on senior specialist of regulatory affairs and quality and compliance with extensive experience in project management, continuous process improvement, procedural document steward and Administrator in VEEVA system as well as department SharePoint site. Proven ability to drive projects while implementing project management methodologies, while leading, training and developing high performing teams. Collaborate with various vaccine colleagues managing CAPA project to completion. Adept at analyzing processes and business needs by ensuring SOPs, PVAs and SDEA are followed to maintain regulatory compliance. Ensuring SOP and PVA are updated accordingly. Successfully leveraging industry knowledge regulatory requirements, strategic thinking, and communication skills to implement continuous improvements which streamlines operations to achieve complete compliance with regulatory requirements.

AREAS OF EXPERTISE

Sr. Specialist, Regulatory Affairs/Compliance Process and Systems Analyst Quality and Compliance & PV Safety Analysts

PROFESSIONAL EXPERIENCE

PA Dept. of Drug & Alcohol Programs (DDAP) (DevCare-ST Contract) Jan. 2024- Present

Regulatory Reform Specialist/Coordinator PM-

●Project Manage regulatory reform of the PA Commonwealth regulations for DDAP

●Collaborate with Licensing, Quality and Compliance

●Review of the regulations to facilitate pertinent parties to proper revisions to the regulations.

●Understanding ASAM guidelines and criteria and ensuring they align with 28 PA Code regulations.

●Successful creation of a survey, distribution to stakeholders to ensure collection of feedback for regulation reform.

●Ensure stakeholders feedback is incorporated into revision of the regulations.

●Manage the project timelines to ensure all contributors are staying on track for meeting timeline according to project projections.

Merck & Co, Inc., Upper Gywnedd August 2015 - April 2023

Sr. Specialist, Regulatory Affairs Compliance Process and Systems Quality Analyst-

●Successfully ensured proper documentation provided for Audits/Inspections from the auditor's request.

●Lead KPI monitoring metrics as compliance indicators, performance trends analysis of root causes.

●Ability to facilitate/anticipate issue resolution and prioritize cross-functional opportunities between interdepartmental teams and outsourced vendors via PVA.

●Ability to lead client meetings and managing project governance

●Ensure all parties are adhering to regulatory drug regulations with submission compliance

●Deviation and CAPA Business process owner within Global Quality Systems

●Leads global drug quality improvements for deviation investigations and provides strategic input for process improvement via collaborating on global drug development plans and enhances SOPs.

●Successfully manage multiple quality, compliance and document management projects and bring Audit/Investigation resolution to a close.

●Identified and resolved business process improvement for documentation and issues interdepartmentally as well as outsourced vendors per SOPs, Business Agreements and PVAs.

●Designed enhanced training (MS Stream videos, hold office hours); to prevent issue practices which may lead to quality deviations or non-compliance events.

●Participate in evaluation of preventive issue topics and write assessment reports, working in collaboration with the senior management team.

●Successfully manage multiple audit and inspection projects and bring resolution to a close.

●Provided continuous process improvement and understands the business process in products from end-to-end.

●Collaboration with various medical colleges on drugs such as vaccines, women’s health (oncology, breast cancer), cardiovascular, Infectious Disease projects for regulatory submissions.

●collaboration with medical affairs teams or contributing to strategic medical plans, scientific communications, or engagement activities with key stakeholders

●Managed vaccine project & maintenance licenses globally.

●Support quality-related information requests raised by various Country Health Authorities and/or vendors regarding product registrations.

●Manage, track and review global regulatory deliverables from external partners in line with the vendor manager.

●Leading project teams, ensuring updated compliance of dept. records and process-related documentation (process maps, job aids, project trackers, checklists)

●Comprehensive knowledge of FDA drug regulations and GCP/GCLP regulations

●Tracked compliance issues in Quality Management System (QMS), policies, and procedures and ensured continuous improvement, managed resolution of CAPA issues, and ensured practice is consistent and compliant with regulatory expectations and industry best practices.

●Track and manage multiple CAPA projects through and to completion.

Procedural Document Steward, Regulatory Affairs -VEEVA Subject Matter Experts (SME)

●Project Manager over entire processes of all functional area department SOPs, Execution Resource documents and maintaining compliance in VEEVA.

●Administrator of VEEVA system and SharePoint team sites for Inspections Readiness documents. Granting permissions to document owners in VEEVA and SharePoint team site.

●Troubleshoot system defects.

●Author, review, approve, and execute Process Change Control Documents (CCD) for VEEVA system RIMS (Regulatory Information Management System)

●Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases in accordance with Good Documentation Practices.

●Collaborate internal for approval of global submission plans in RIMS (Regulatory Information Management System)

●Maintain and organize internal files; agreements, supporting documents, meeting minutes.

●Assess and communicate potential regulatory risks and propose mitigation strategies.

●Successfully, works closely with process owners and manages the collaboration with authors and assists with updates/revision/obsoletion of documents.

in the system (VEEVA) and RIMS (Regulatory Information Management System)

.

●Participated in GRACS Quarterly Periodic Review Document Team, as a document expert. Tracked and managed the 3 year periodic review for the remediation cycle and workflows ensuring documents are in compliance.

●Ensure systems and documentation remain compliant with regulatory requirements, cGMP, 21 CFR Part 11, ICH E6 (R2) and in accordance with the company's SOPs and processes.

●Successfully managed and maintained all personnel CV and JDs for yearly review and signature on share point team site with 100% compliance.

Merck & Co, Inc., Upper Gywnedd Jun 2016- Jun 2017

Senior Specialist, Regulatory Submission Manager-Regulatory Affairs (RSM)-

●Facilitator of meetings to build and drive regulatory cross-functional teams for regulatory planning and execution of safety submissions to agencies.

●Collaborate internal for approval of global submission plans; ensure those plans can be executed with internal and external resources on time

●Supervised monitoring of vendors for compliance of regulatory submissions.

●Identified and assessed to actively resolve/escalate compliance risks impacting the successful submissions.

●Review scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.

●Support regulatory submissions for eTMF modules and RIM and labeling review and approval throughout the E2E labeling process.

●Lead continuous improvement activities, for business processes, tools, systems, metrics and analytics.

Merck & Co, Inc., Upper Gywnedd Jun 2016- Jun 2017

Dual role- Senior Specialist, Regulatory Report Coordinator (RRC)-

●Prepared submission of Aggregate Safety reports, PSURs, PAER, DSURs.

●Trained and mentored new hires to function in the RRC roles independently.

●UAT tester for Sportfire system for department use of tracking PV tends and KPI reporting to upper management.

●Provides information to Global Labeling Compliance, as required, to support internal and external ( i.e. Regulatory Authority) requirements and support audits/inspections as a labeling subject matter expert.

●Ensure the correct update CCDS for US and EU labeling and other key global labeling information are included in safety reports documents.

Merck & Co, Inc., Upper Gywnedd Aug-2015 – Jun 2016

Sr. Specialist, Global Aggregate Report Manager/ Project Manager-

● Prepared submission of Aggregate Safety reports, PSURs, PAER, DSURs.

Project Manager (PM) for Aggregate Reports-

●Created project plans and tracked status of reporting issues to department management, project sponsors and business partners.

DOCS (Merck-Upper Gywnedd) April 2015- Aug 2015

Senior Clinical and Regulatory Analyst – III-

●Managed preparation/submission of Aggregate Safety reports, through collaboration with Clinical Research/Safety & Risk Management, Labeling/Regulatory Affairs.

Clinical (Otsuka)- Remote & Office-Princeton NJ Nov 2013- Mar 2015

Aggregate Report Associate-Global PV-

● Managed Aggregate Safety Reports; Regulatory Intelligence POC for country regulations.

Teva -Drug Safety Associate-Horsham PA Oct 2013- Nov 2013

Aerotek (Teva Horsham PA) PV Aggregate Reports-

●Processed Periodic Adverse Drug Experience Reports; Safety Label Changes/review; Website & social media site monitoring.

Aerotek- (Merck Upper Gwynedd, PA) Jan 2011 – Jan 2013

Aggregate Reports/Projects Manager, Global-

●Prepared and managed Aggregate Reports; Maintained and reviewed Business Partner/CRO contract agreements.

inVentive Clinical Solutions-Newtown PA Aug 2010- Oct 2010

Clinical Data Reviewer (CDR) (Pfizer) – Short Term Contract (remote)

●Served as Clinical Data Reviewer; phase 3 data capture.

Covance -Princeton, NJ May 2008 – May 2010

Global Manager, Drug Safety Services-

●Managed Global Clinical Safety\PV projects of Serious Adverse Events in Trackwise system per SDEA.

●Work closely with local and global personnel to ensure input of PVAs and SDEAs meet regulatory requirements locally and globally.

●Created and reviewed PVA for management of vendors and/or clients

ICON Clinical Research North Wales PA May 2007 to May 2008

Clinical Research/ Drug Safety Associate-

●Clinical trial site patient monitoring, clinical data (CRFs) capture per study procedures and protocols.

Sanofi-Synthelabo Inc. -great valley PA June 2005 – May 2007 Clinical Safety Officer - Clin Ops-

●Ensured sites & CRA adhered to protocol for product storage, patient care and documentation.

SYSTEMS SKILL SET

Microsoft office VEEVA Analysis of Scientific Data Documentum TrackWise sharepoint elearning systems Teams & WebEx Remote Trainings/Presentations Inform Successful Facilitate Cross-Functional Team Collaboration Phase Forward EDC IVRS ESTAR Spotfire

EDUCATION

Holy Family College- Bachelor Science Nursing

Clinical Research Associate Program-Certification

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