Counsel - Regulatory Compliance

September 15

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Viatris

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Pharmaceuticals • Generics • Anesthesia & Pain Management • CNS • Cardiovascular

10,000+

Description

• Responsible for counseling clients on a wide range of regulatory compliance issues with focus on GxP and Quality processes for the development, manufacture, and distribution of drugs, biologics, medical devices, supplements, and cosmetics. • This position works collaboratively with cross-functional teams to develop communications with regulators, including responses to health authority inspections and inquiries, and post-marketing reports. • Provide timely and effective counsel related to compliance with GxP regulations from various health authorities (e.g., FDA, EMA, TGA, Health Canada, WHO). • Assist with development of corrective action plans and responses following regulatory inspections and inquiries. • Assist in developing materials for regulatory meetings and preparing teams participating in such meetings. • Participate in committee meetings to review internal quality metrics and participate in site or project governance committees, as needed. • Provide guidance on product quality incidents and post-marketing reporting obligations and actions. • Work cross functionally with Quality, Regulatory, and other stakeholders to advise on and support process and systems improvements, including development of global quality policies and training materials. • Prepare and edit written reports and communications for internal and external use related to regulatory and GxP compliance requirements and obligations. • Monitor the external environment and advise teams on policy and regulatory developments related to GxP and related activities. • Manage engagements with outside counsel to ensure effective and efficient use. • Perform related duties as assigned.

Requirements

• Juris Doctorate is required and 7 years of experience in Pharmaceutical or biotechnology industry as inside or outside counsel. • Three to five years of technical expertise in manufacturing and GxP auditing preferred. • Related experience/education may also be considered. • Seven years of Legal experience advising clients directly or under the supervision of lawyers. • Licensed to practice law in one or more jurisdictions is required. • Exceptional oral and written communication skills, including strong presentation capabilities. • Strong interpersonal and conflict resolution skills. • Ability to work in a collaborative, team-oriented environment. • Background/education in science related discipline is preferred. • Proficiency in speaking, comprehending, reading and writing English is required.