Senior Regulatory Counsel
Senior Regulatory Counsel
United Kingdom - Uxbridge
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Gilead is seeking a Senior Regulatory Counsel, reporting to the Lead Global Regulatory Counsel. The candidate will be responsible for providing regulatory law advice for the ACE region (Australia, Canada, Europe), as well as other markets as needed, in critical aspects of the business' regulatory law compliance and strategy throughout the product life cycle.
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 serve on the International Regulatory Affairs Leadership Team and liaise closely with the Regulatory organization, as well as groups within Global Supply, Quality, Safety and Pharmacovigilance. The candidate will work closely across Gilead's legal organization to coordinate and communicate legal input on regulatory matters in close alignment with ACE and regulatory leadership across geographic and therapeutic areas.
Core Job Responsibilities Include
- Provide regulatory law advice and interpretation for the portfolio of Gilead products;
- Provide legal guidance to the Regulatory organization and product teams with respect to interactions with regulatory agencies;
- Keep up to date and maintain knowledge advising on pertinent regulatory issues faced by the business in key markets;
- Support and collaborate in a matrix structure with legal colleagues in Foster City and International Affiliates;
- Support and facilitate the commercial business therapy area teams through close working with Legal groups that support these teams;
- Serve as regulatory law business partner to the International Regulatory Affairs Leadership Team;
- Follow developments in applicable laws and regulations in the ACE region and work with the Global Regulatory Policy and Governmental Affairs groups as well as external organizations on policy issues;
- Working with other attorneys within the legal department and the business, advising on complex regulatory-related issues including: product approvals, regulatory supply chain issues, packaging and labeling, transparency initiatives (e.g. EMA Policy 0070), Orphan Medicines, Paediatrics, regulation of Clinical Trials, GxP, compliance and inspection support, Marketing Authorisation Holder and Manufacturing Authorisation holder responsibilities, Pharmacovigilance, regulatory data protection (RDP), compassionate use (CU) and expanded access, dual brands, ATMP and Medical Devices;
- Providing regulatory-related legal advice concerning business transactions.
- Risk evaluation including penalties and the inter-section with competition law
- Fully qualified legal credentials in one or more geographies of operation.
- Fully admitted to practice law in the respective country or jurisdiction.
- Professional experience in-house and/or at a law firm working in biotech or the pharmaceutical industry and expertise with respect to EU laws and regulations, with extensive experience in pharmaceutical/regulatory law legal practice.
- 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.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
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