Senior Regulatory Counsel - GxP and Global Patient Safety
Gilead is seeking a GxP and Global Safety counsel, reporting to the Lead Global Regulatory Counsel. The candidate will be responsible for advising and collaborating on a broad range of R&D and commercial related activities, including manufacturing, testing, labeling, pharmacovigilance, and all applicable GxP requirements. This role will be based in our offices in Foster City, California, however, for the right opportunity, we may consider this as a remote position.
The successful candidate will be able to work independently and possess strong knowledge of regulatory laws, rules and regulations, industry practices and standards, and have demonstrated experience in analyzing complex issues and developing innovative solutions to business challenges. The candidate will possess a strong business acumen and legal expertise to proactively identify, analyze, and navigate potential legal and compliance issues and risk within areas of responsibility and formulate and communicate compliant and practical solutions that meet business objectives. The candidate will liaise closely with CMC and Global Supply, Quality, Regulatory Affairs, and Global Patient Safety.
The candidate will work across Gilead's legal organization to coordinate and communicate legal input on matters in close alignment with compliance, Anti-Counterfeiting Team (ACT), Global Therapeutic Area Leadership (GTAL) and regulatory law functions across geographic and therapeutic areas.
Core Job Responsibilities Include
- Providing legal support and guidance on data integrity and compliance issues impacting CMC, product quality, GCP, GLP and GMP;
- Advising business on a variety of supply chain issues, including drug shortages, product recalls, compassionate use and expanded access supply, regional export and import requirements;
- Providing guidance and support on Quality Agreements, including review of internal agreements and external work with vendors and collaborators;
- Strategic partner and counsel for Global Patient Safety on safety related measures, including REMS and post-marketing safety commitments;
- Strategic partner and counsel for regulatory affairs on product labeling, post-marketing requirements (PMRs);
- Providing legal support for regulatory inspections, advice on responding of 483 findings, market actions, and related regulator communications;
- Support the lead regulatory counsel on a variety of legal matters;
- Proactively identify the need for, draft, and provide legal advice on corporate policies, SOPs, and guidance documents;
- Serve as part of matrixed teams and collaborate effectively, including partnering with other members in the Legal and Compliance Departments to ensure consistency in approach across areas of the overall business;
- Establish strong partnership relationships with global research and development teams, as well as key cross functional teams engaged in development activities characterized by a high-level of collaboration and mutual respect;
- Drive increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the business and other key stakeholders;
- Define, direct, and conscientiously manage the work of outside counsel;
- Accountable for providing senior stakeholders with training and updates, policy support and learnings to support effective risk management.
- U.S. Juris Doctorate (J.D.) degree; active law license in at least one U.S. jurisdiction,
- 7+ years of legal experience supporting clients in the pharmaceutical industry, preferably at a multinational company and/or a reputable, highly rated law firm, or a combination of both;
- Experience advising clients on FDA matters, GxP and Patient Safety;
- Ability to exercise judgement and independently determine and take appropriate action.
- Ability to translate complex legal requirements into practical suggestions and solutions.
- Ability to manage workload priorities in a matrix environment.
- Experience handling multiple projects in fast-paced environment, with a high degree of client service orientation, and performing successfully in cross-functional teams.
- Able to independently handle complex matters with minimal supervision. Understands when to elevate issues to senior management for awareness or decision.
- Has proven judgment in working through complex issues, including those with significant strategic risk to the company.
- Demonstrated excellent interpersonal, strategic thinking, communication and organizational skills.
- Consistent demonstration of Gilead's core values: Teamwork, Accountability, Inclusion, Excellence and Integrity
Critical Success Factors
- Judgment: Demonstrates expertise and sound judgment, understands how assigned responsibilities support Gilead's business objectives, and is able to provide practical, risk-balanced advice based upon a thorough understanding of the scope of an issue, taking full advantage of internal networks and external intelligence. Ability to work in grey areas and solution oriented.
- Collaboration: Works in close collaboration with others to gain a firm understanding of available legal, functional, and business resources, integrates information from a number of sources, capably navigates a matrixed environment and works well in a team in order to achieve optimal business results.
- Anticipation: Anticipates changes in law, enforcement, and/or business objectives, develops contingency plans, and adapts approach as necessary to manage risks effectively and mitigate issues before they arise.
- Influencing Skills: Builds strong relationships with business partners to tactfully influence and gain their support to drive desired outcomes. Represents Gilead externally to customers, suppliers, competitors, trade associations or government agencies. Resolves or avoids legal issues using negotiation skills and legal expertise/engage in external influencing efforts.
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