Why choose RAS?

Staying on top of the constantly shifting regulatory landscape in the United States and in other countries isn’t easy, but the success of your business depends on it. Failing to comply with regulations is not an option, regardless of which stage in the drug, device, biologic, or combination product area you operate in. Abiding by the law is a major commitment to your shareholders, employees, customers, and ultimately patients. Trust experts whose number one priority is to simplify compliance with honest, accurate and timely regulatory advice.

How can we support your program?

Meet the Team

Barbara J. Patterson

Corporate Senior Vice President, Regulatory Affairs & Compliance Management

Head shot of Barbara J. PattersonBarbara joined Charles River with the acquisition of The Primedica Group, where she was the Senior Director of Regulatory Compliance.

 

 

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    With over 30 years of experience, Patterson has played a pivotal role in developing a world-class regulatory affairs and compliance organization. She was promoted to Corporate Vice President, Global Preclinical Services Quality Assurance & Compliance. In this role, Barbara was instrumental in leading numerous quality assurance and compliance initiatives that helped the company achieve a reputation for excellence among clients. In 2014, her role was expanded to include Regulatory Affairs, and she was promoted to Corporate Senior Vice President, Regulatory Affairs & Compliance soon after. In this role, Patterson will assist the company in maintaining the high standards required by clients and regulatory agencies worldwide. Barbara holds a BA degree from Pennsylvania State University.

Melanie Drayton

Senior Director, Regulatory Affairs

Head shot of Melanie DraytonAs a former investigator at the Office of Regulatory Affairs (ORA) and project manager at the US FDA Center for Biologics Evaluation and Research (CBER), Melanie has deep experience in the design, development, manufacture, distribution, and post-marketing surveillance (pharmacovigilance, adverse events, and safety issues) of biological, combination, medical device, and pharmaceutical products.

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    Over the course of her career, she has inspected, investigated, and reported on FDA-regulated biologics, bioresearch monitoring, drugs, dietary supplements, and medical devices.

    Melanie also served as an independent consultant, offering strategic, sustainable solutions for her clients’ compliance and regulatory programs, including the creation and reorganization of quality systems, quality system remediation, auditing, due diligence, quality management system assessment, and strategic planning. An experienced auditor, she has conducted audits of manufacturers and suppliers, contract test laboratories, and contract sterilizers and performed FDA mock inspections/ISO audits for life science companies. Melanie has specialized in quality and regulatory compliance of life science products for more than a decade, and is considered a subject matter expert for several regulatory authorities.

Stephanie Cochran

Associate Director of Regulatory Affairs

Head shot of Stephanie Cochran, MS, PMPStephanie is a former Lead Consumer Safety Officer for FDA’s Center for Devices and Radiological Health (CDRH), Office of Compliance, primarily responsible for resolving process-related challenges and expediting responses to highly complex, high-level inquiries of post-market medical device product recall actions.

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    During her tenure at the FDA, she effectively served in various capacities including Investigator, State Liaison, and Emergency Response Coordinator for FDA’s Office of Regulatory Affairs (ORA).

    Her varied roles with both ORA and CDRH have improved her experience as a skilled liaison and regulatory expert, fostering communication and understanding between diverse working groups, clients, and the FDA. Additionally, she maintains the ability to effectively interpret regulatory policy and guidance, spanning multiple product areas. Prior to joining the FDA, she worked as a Health Physicist for the Tennessee Department of Environment and Quality. She earned an MS in Basic Medical Sciences from University of Alabama at Birmingham and a BS in Chemistry from Tennessee State University.

Miriam Rosario

Associate Director of Regulatory Affairs

Head shot of Miriam RosarioMiriam is a trained quality systems professional with extensive experience in FDA and ISO quality systems requirements and an extensive background in CGMP environments for medical devices, biologics, finished pharmaceuticals, in vitro diagnostics, dietary supplements, API, and combination products.

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    Over the course of her career, she has managed multiple plants for numerous companies in the US and South America. She has audited numerous companies in the US, South America, Europe, and Asia, and has served as a worldwide independent consultant.

    She is a subject matter expert for industry regulations, including QSR, 21 CFR Parts 11, 111,211, 820, ISO 9000/13485/14971 and the Medical Device Directive, and can readily advise clients on supplier qualification and management, production and process controls, equipment qualification, CAPA, investigations, recalls, MDRs, establishment registration/licensing, and product listings. Miriam graduated with a BS in chemistry from the Universidad de Puerto Rico, Bayamon & Manati, and is multilingual.

Sam Mooney

Manager, Regulatory Affairs

Head shot of Sam MooneyAs a communications and research professional, Sam manages a team of specialists who study global government regulations to ensure that Charles River clients have access to the latest guidelines and news that may impact their development projects.

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    Supporting the pharmaceutical, biotechnology, and industrial and agrochemical sectors, as well as manufacturers of sterile products, Sam and his team communicate the latest regulatory intelligence, report on trends, and advise Charles River’s project management teams regarding USDA, FDA, EMA, China, and other global regulatory authorities’ guidance documentation.

    Sam holds a BS in journalism from Indiana University, and has assured quality and conducted research for companies like Eli Lilly and CNBC. Sam’s deep experience in information management systems drives his team’s collection and dissemination of global regulatory data to support our clients’ programs.

Alison Carter

Regulatory Affairs Specialist

Head shot of Alison CarterAlison has worked in the field of fraud protection for over 20 years. She began her career at American Investigative Services, Inc. as a private investigator, conducting background checks, insurance fraud investigations, and loss prevention.

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    Alison worked at Fidelity Investments as part of their background investigations team, primarily working on background checks for new hires and current employees. She then served as a consultant monitoring Code of Ethics violations and electronic communications for potential violations under the SEC and FINRA.

    Alison moved to the Fraud Investigations department at Fidelity, where she conducted fraud investigations, monitored internal client account activity for any suspicious activity, and prepared reports for internal clients, industry peers, and even the FBI. After taking some time off to care for her children, she joined the law offices of Moody, Famiglietti, and Andronico as their Operations Coordinator. She was primarily focused on managing audit confirmations, both internal and external, and preparing statements for partners and clients.

    Alison received her AS in paralegal studies from Newbury College and a BS at the Northeastern University College of Criminal Justice.

Amber Polia

Regulatory Affairs Specialist

Head shot of Amber Polia Amber came to Charles River from TetraGenetics, where she served as a research associate for four years. She worked on recombinant ion channels for therapeutic antibody discovery while analyzing pertinent data, fostering relationships with new and existing vendors, and presenting project findings at company meetings.

 

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    Amber also worked as a temporary research assistant in the Molecular Neurogenetics Unit at Massachusetts General Hospital’s location in Charlestown, MA.

    Amber has a Bachelor of Arts degree in neuroscience from Boston University.