Beacon Regulatory Consulting, LLC provides regulatory expertise to support drug and biologics development.

Responsibilities include:- Manage the US team to support all regulatory activities for investigational and licensed products in the US, EU and 24 Emerging Markets- Provide leadership in conceptualization, prioritization, planning, development and implementation of regulatory-related projects for all Kedrion sites- Partner with core business units (Operations, Marketing, Quality Assurance, Medical Affairs, and Pharmacovigilance) to lead efforts in project development and regulatory strategies- Serve as the company appointed FDA, and other regulatory agencies, contact - Maintain expert knowledge on US and International laws and regulations to ensure complianceSelected accomplishments include:- Developed systems/processes for new product registrations and renewals- Established a Promotional Material Review process- Expanded the regulatory department

Responsibilities include:- Managed US product lifecycle for over 9 international Sponsors- Subject matter expert in providing regulatory strategy to Sponsors- Coordinated and compiled regulatory communications and submissions, to FDA, EU and Canadian authorities.- Kept abreast with new regulations and guidelines (USA and international) as they pertain to product development and clinical research and notify regulatory, quality and clinical colleagues.- Reviewed IRB/IEC/REB/Privacy Board approvals for protocols, Informed Consents, Authorization Forms including approvals for drug shipments and other documentation, as required.- Participated in RA/QA auditing, including the preparation of written audit reports and ensuring that all critical deficiencies found are corrected for:o Contractors such as testing laboratories, investigational product storage and distribution vendors, etc. for compliance with GXP (cGMP/GLP/GCP/GDP regulations as applicable)o Clinical study sites for compliance with local/national (e.g., FDA, EU, HC) and ICH Guidelines of Good Clinical Practices- Researched regulations and regulatory guidelines (USA, EU and Canada), as well as scientific literature, for regulatory projects and as requested by regulatory, quality and clinical colleagues- Performed other duties as required to accomplish the goals of CROfessionals Clinical Department, Quality Assurance and Regulatory Compliance DepartmentSelected accomplishments include:- Approval of Biologics License Application for a foreign manufacturer- Compilation, submission and maintenance of three INDs

Responsibilities include:- Provided Regulatory and QA support on multiple new development project teams - Responsible for GMP and GLP audits of contract research organizations, suppliers, vendors and third party manufacturers - Provided QA review for executed batch records and product release paperwork- Reviewed and approved all CMC changes by Reckitt and by Reckitt's third party manufacturers, contract packagers and distributors. Regulatory agency notification was dispositioned at the time of CMC approval (CBE-0, CBE-30, PAS or Annual reportable)- Processed product quality complaints and championed investigations as needed- Provided support for all submissions to Domestic and International regulatory agenciesSelected Accomplishments- Submission and approval of 2 NDAs- Co-developer of an Office of Inspector General (OIG) Compliance Program

Responsibilities include:- Lead a team of 3 Device Label Editors - Developed a disposable device label editing training curriculum, and facilitated the training of new device label editors- Responsible for the creation, review and maintenance for all disposable device labeling Selected accomplishments include:- Developed and facilitated corporate label approval training class- Successfully created/revised new company labeling for 150 devices within 6 months

Responsibilities include:- Responsible for the development and maintenance of labeling and specifications for all HPD disposable devices- Represented corporate labeling department on multiple cross-functional project teamsSelected accomplishments:- Authored the first CA/PA for Abbott

- Responsible for the preparation of Abbott Laboratories'​ device registration packages to meet requirements of Abbott Laboratories'​ International Affiliates. - Liaison between Abbott Laboratories' Manufacturing Plants and approximately 70 International Affiliates.