Health (Regulatory)

 

• Ensures all regulatory compliance with state and Federal agencies related to the health care industry.

 

• Training of personnel (such as management, sales, finance, and operations) for compliance awareness.

 

• Development, implementation and evaluation of policies and procedures for specialty pharmacy programs.

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• Drafting and negotiation of compliant specialty and retail pharmacy payer contracts for retail pharmacies.

 

• Drafting and negotiation of compliant limited-distribution drug contracts with drug manufacturers for retail pharmacies.

 

• Drafting, negotiation, maintenance and continuing compliance for specialty pharmacy accreditation contracts for standard terms of generally 2-3 years or longer, as may be negotiated, such as the Accreditation Commission for Health Care (ACHC), TJC (The Joint Commission), Utilization Review Accreditation Commission (URAC) and Verified Internet Pharmacy Practice Site (VIPPS), and analysis of data (data analytics) for various compliance initiatives.

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• Legal support for the development of compliant protocols and procedures, based on comparative analysis related to patient total cost of care utilizing legacy and current skill sets in statistical analysis.

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• Review and recommendations regarding proposed promotional materials to ensure compliance with FDA requirements and to identify and mitigate potential risks.

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• Consultation concerning relevant industry practices, state and Federal statutes and regulatory standards that affect the development and commercialization of pharmaceutical and biotechnology products, such as the 1863 False Claims Act (FCA) (31 U.S.C. § 3729 – 3733, “Lincoln Law”), 1977 Foreign Corrupt Practices Act, 1983 Orphan Drug Act, 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman), 2010 Physician Payments Sunshine Act, 2013 Drug Quality and Security Act (DQSA), Accreditation Council for Continuing Medical Education (ACCME) guidelines, clinicaltrials.gov research and reporting, Codey Law (New Jersey Physician Self-referral Law, N.J.S.A. 45:9-22.5 et seq.), drug development cycle, expedited programs for serious conditions, fraud and abuse regulations, good and compliant practices in various disciplines (GxP), International Committee of Medical Journal Editors (ICMJE) standards, International Society for Pharmacoepidemiology Guidelines for Good Pharmacoepidemiology Practice (ISPE GPP), New Jersey Board of Medical Examiners, Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines, privacy laws, product liability, promotion and scientific exchange, regulatory submission standards, “Stark Law” (42 U.S.C. § 1395nn, "Limitation on certain physician referrals"), transparency laws.

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• Liaison to state, Federal and international regulatory agencies, to facilitate the review and approval process for applications, commitment closures and supplements. 

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• Ensures compliance with regulatory standards through spot audits.

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• Assisted with the preparation of global regulatory strategies for assigned emerging market (EM) countries, including the review of existing country-specific competitor products, regulatory guidelines and relevant literature (such as advertising, labeling and promotional material). 

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• Developed a thorough understanding of regulatory guidelines and technical requirements for EM countries. 

 

• Ensured that all regulatory filings in assigned EM countries were accomplished in a timely manner.

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• Prepared controlled correspondence – any correspondence related to either the evaluation of clinical content, or that request evaluations of alternative bioequivalence (BE) approaches within the same study type (such as clinical, or pharmacokinetic), or relating to a review of BE protocols for drugs that reference listed drugs with risk evaluation and mitigation strategies (REMS) with elements to assure safe use (ETASU) – pursuant to the Food and Drug Administration Reauthorization Act (FDARA) (GDUFA) guidelines.

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• Ensured application of the appropriate user fees, pursuant to either the BIosimilar User Fee Amendments (BsUFA) to the Food, Drug, and Cosmetic Act (FD&CA), or the GDUFA guidelines, or the Prescription Drug User Fee Act (PDUFA) and then coordinated with relevant stakeholders to ensure timely payment of such applicable fees.

 

• Supported pharmacovigilance (Pv) risk evaluation and mitigation strategies (REMS) for assigned projects and products

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• Responsible for evaluating, negotiating and securing financially and administratively compliant and favorable contracts physician agreements, procurement, sourcing and vendor agreements, employment contracts, medical staff matters, managed care agreements, professional services, equipment leasing and purchasing, software license and any other legal documents as required with new and existing health plans.

 

• Utilizing risk tracking mechanisms, develops reports and analyses to expose potential risks and gaps that need corrective action or preventative action.

 

• Monitors all state and Federal regulations and industry developments and trends affecting the health space.

 

• Reports relevant changes in Federal and or state laws and industry developments and trends to management through detailed and analytical reports, and provides recommendations for changes to existing and proposed contracts, plans, procedures and protocols.

 

• Legal research for current trends and issues, periodic reports to management and training presentations.

 

• Legal support for the internal government relations teams on state licensing matters, such as new applications, credentialing, re-credentialization, audits and regulatory hearings.

 

• Provides pre-market and post-market compliance counseling and regulatory consultation regarding Federal and state laws, guidelines and industry standards impacting a life sciences company.

 

• Legal support for the procurement, installation, and qualification for compliance with Current Good Manufacturing Practices (CGMP) of equipment for manufacturing and laboratory use.

 

• Developed and implemented compliance policies, programs, standard operating procedures, work instructions and guidelines, relating to the distribution and commercialization of products regulated by the U.S. Food and Drug Administration (FDA), and experience providing FDA regulatory advice to biotechnology, life sciences, medical devices and pharmaceutical companies.

 

• Provides customized FDA compliance training covering areas such as the Office of Inspector General (OIG) guidance requirements, anti-kickback laws, false claims, fraud & abuse and promotional reviews.

 

• Review and recommendations regarding proposed promotional materials to ensure compliance with FDA requirements and to identify and mitigate potential risks.

 

• Conducted investigations and audits regarding employment-related concerns and code of conduct violations.

 

• Prepared reports, strategic plans, informational materials, guidelines and budgets for domestic and international records management and records retention efforts.

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• Regulatory compliance for assigned projects and products, aligned with the strategic goals of the enterprise.

 

• Managed the regulatory aspects of projects and products, such as the preparation and submission of applications and correspondence to state, Federal and international regulatory agencies.

 

• Reviewed and commented on safety aggregate reports for assigned projects and products.

 

• Reviewed all advertising, labeling and promotional material for assigned projects and products.

 

• Implemented corporate regulatory policies and protocols to support and maintain registrations for assigned projects and products.

 

• Assisted in gaining new product licenses, and maintained a portfolio of existing product licenses for assigned products.

 

• Prepared clinical trials directives (CTDs) and international registration documents (IRDs) in collaboration with the relevant subject matter experts (SMEs), for assigned projects and products.

 

• Coordinated the receipt, distribution and response to regulatory inquiries with the applicable strategists, aligned with the product goals, and consistent with enterprise procedures and including members of the rapid response team (RRT), to ensure the consistency of the response messaging. 

 

• Attended meetings with regulatory authorities, prepared background materials and presentations therefore, coordinated the logistics of other mandatory attendees, and then took minutes of meeting notes which were disseminated to all relevant enterprise personnel after the meeting, for review and comment.

 

• Ensured that comprehensive records of communications with governmental agencies and regulatory compliance tracking was maintained.

 

• Authored, complied and reviewed amendments, annual reports, correspondence, original submissions, supplements, other required correspondence related to abbreviated new drug applications (ANDAs), biologic license applications (BLAs), investigational new drug (IND) applications and new drug applications (NDAs).

 

 

• Legal support for the regulatory affairs department activities, such as clarification requests, coordination of submission timelines with overseas counterparts, detained shipments information, electronic publishing, Freedom of Information Act (FOIA) requests, product labeling updates, preparation of monthly regulatory reports, regulatory intelligence, sample submissions and tracked submitted correspondence.

 

• Responsible for maintaining and updating the applicable regulatory databases.

 

• Archived electronic and paper regulatory documentation pursuant to the applicable domestic and international document management and records retention statutes and applicable corporate policies.

 

• Legal support for regulatory issues related to various ancillary departments, such as customer service, distribution, information technology (IT), intellectual property (IP), logistics, manufacturing, marketing and sales.

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• Developed and implemented regulatory-related corporate policies, protocols and standard operating procedures (SOPs). 

 

    Last updated 210509_1614