The FlexPro Group/Network Partners Company a professional services firm that serves the medical device, pharmaceutical and biopharmaceutical industries with core competencies in Regulatory Affairs, Packaging Engineering, Labeling, Quality and Project Management. www.networkpartners.com-- Manage pharmaceutical pre-approval & post-approval (global CMC) projects for drugs & biologics. -- Prepare, review & submit regulatory documents (e.g., IND/IMPD, BLA, MAA) in US/Canada, EMEA & APAC.-- Coordinate across client organization & external partners to project manage CMC regulatory issues. -- Maintain & track global regulatory requirements, records & official correspondences. -- Support process improvements.-- Mentor & train associates on best practices (Regulatory Apprentice Leadership Program).

-- Manage various Regulatory Affairs (RA) projects focused on FDA eCTD submissions (PAS, CBE/CBE-30, BLA/IND Annual reports, Post Marketing Commitments, and Distribution reports) for ADMA Immune Globulin product pipeline.-- Direct, assist and review documentation in preparation for regulatory filings with Subject Matter Experts(SMEs), including assessment of CMC sections of BLAs requiring updates.-- Establish and meet team timeline commitments made to FDA.-- Support FDA inspections and updating of ADMA SOPs and Site Master file.-- Provide regulatory strategies and ensure compliance with current regulations

-- Managed projects/operations involving internal departments, external contract manufacturing organizations (CMOs) & partners (Amgen, Lonza, Wyeth Biopharma, Meridian Medical, Cardinal Health). Responsibilities:-- Single point of contact for communicating and addressing quality control issues (e.g., lot release, process validation, method transfers) between Genentech departments’ worldwide and external parties. Designed and created standard operating procedures and process flow. Coordinated and managed transfer of raw materials, and quality control release testing method transfer activities (writing protocols/reports/specifications). Ensure that contract data records are completed in accordance with regulatory requirements, Genentech policies and procedures. Interface across all departments and sites to resolve all issues before final reviews. Develop/implement quality systems with contract manufacturers by working with all internal stakeholders (R&D, finance, manufacturing, quality assurance, regulatory, legal), and senior management. -- Manage QC technical/compliance data review (approve Certificate of Analysis), including preparation for internal management & FDA audits. -- Support CMC activities for various Genentech/CMO submissions and post market activities such as Product complaints, Annual Product Review (APRs) etc.-- Support compliance audits and regulatory inspections for new and qualified CMOs. -- Initiate, assess, and approve internal and external document change controls, Discrepancies and CAPAs -- Provide regular updates, status reports and presentations to internal departments and external partners.

-- Managed testing & analysis of Children’s Tylenol and Motrin products from development through product launch. -- Lead analyst responsible for hiring/overseeing temps, developing/validating analytical methods, securing management approval of protocols/reports, ensuring GMP/compliance & transferring methods/specifications/protocols to production.