The Lead Regulatory Corporate Counsel will be the point person for providing practical, timely, and high quality legal services in the regulatory area, which covers a broad spectrum of internal clients (Regulatory, Quality, Safety, R&D, Clinical, Compliance, Business Development, and Government Affairs). This position will report to the VP, Commercial and Regulatory Legal.
•Support life-cycle management of company products including compound development, clinical development, NDA submission, and commercialization.
•Advise on compliance with post-market regulations, including adverse event reporting and pharmacovigilance, recalls, and good manufacturing practices.
•Provide regulatory support for transactions, including conducting regulatory due diligence, negotiating key regulatory terms and supporting post-transaction integration activities
•Draft comments on proposed laws and regulations, FDA guidance documents, and industry group policy positions
•Serve as legal representative on grants committee (IIS and CME), label review group, material review board, and managed access committee.
•Provide regulatory support to brand attorneys on advertising and promotion issues
•Keep abreast of regulatory developments affecting clients anticipate potential obstacles in obtaining desired regulatory outcomes and generate revised strategies to solve issues (e.g., cell and gene therapies, clinical trial reporting, mobile medical applications, track and trace). Regulatory responsibilities include:
•Provide solutions-oriented advice for obtaining FDA approval, including advising on the preparation and filing of regulatory documentation with FDA, formal meetings with FDA, advisory committee meetings, label negotiations, complete response letters, dispute resolution proceedings, user fees, the 505(b)(2) pathway, the fixed dose combination drug rule, and special protocol assessments.
•Advise on issues specific to expedited FDA programs for serious conditions, such as accelerated approval, fast track designation, breakthrough designation, priority review
•Provide strategic advice relating Hatch-Waxman, pediatric, and orphan exclusivity.
•Advise on issues pertaining to FDA establishment registration and product listing.
•Provide counsel on import-related enforcement actions, including responses to FDA Notices of Detention, Import Alerts, and FDA/customs releases.
Clinical/Medical responsibilities include:
•Oversee the negotiation of confidentiality agreements, informed consent forms, agreements with contract research organizations, collaboration agreements, clinical trial agreements, and other agreements related to clinical trials with sophisticated counterparties such as such as hospitals, teaching institutions, universities, contract research organizations, and other clinical vendors
•Advise clients on issues concerning good clinical practices (GCP), IND safety reporting, clinical holds, IRB relations, HIPAA, clinical investigator disqualification proceedings, investigator-initiated research (IIR), pharmacovigilance.
Quality responsibilities include:
•Assist Quality organization in preparing for audits and inspections by regulatory authorities, responding to FDA Form 483s and warning letters, developing remediation work plans, and conducting market withdrawal/recall/field action analyses
•As the legal representative on the material review board (MRB), assess risks posed by critical process changes and product nonconformances and deviations.
***Relocation Assistance available for qualified applicants
· Law degree from an ABA-accredited law school
· 6-8+ years of experience advising on laws, regulations and industry standards applicable to the pharmaceutical or biotechnology industry and relating to research and clinical development, regulatory approval, commercialization, manufacture, complaint handling, pharmacovigiliance, and recalls.
· Ability to work independently with minimal supervision.
· Strong oral and written communication skills.
· Ability to analyze issues, discuss options, and recommend courses of action arising from activities governed by:
Good Clinical Practices (GCP) Good Laboratory Practices (GLP) Good Manufacturing Practices (GMP) Good Pharmacovigilance Practices (GVP) ICH Guidelines FDA regulations and guidance concerning advertising, promotion, and labeling Hatch-Waxman Act and Orphan Drug Act Anti-kickback statute and fraud & abuse laws HIPAA PhRMA/BIO codes False Claims Act OIG Guidance and advisory opinions Sunshine Act FDAMA 114 REMS requirements DQSA & track and trace PDUFA
Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.
Founded in 1989 in Cambridge, Mass., Vertex to...day has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For four years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit www.vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.