Overview

Global Therapeutic Area (TA) Regulatory Liaisons – Associate Director at Gilead Sciences. The global regulatory affairs team supports strategic decisions to enable access for patients to our molecules. This role is within the Virology IC/GPS Franchise, covering the Intercontinental and Gilead Patient Solutions region, and working across territories in Asia, Latin America, Africa, Eastern Europe and the Middle East. As the Regional Regulatory Lead, you will lead, manage and oversee complex regulatory strategies for one or more products or projects in the Virology therapeutic area; define regulatory strategy, plans and objectives; manage regulatory submissions and other projects; and represent the IC/GPS regulatory franchise on cross-functional core and sub-teams. You will provide strategic and technical advice from development through the product lifecycle for HIV, Hepatitis and/or Emerging Viruses projects/products. You will oversee preparation and maintenance of regulatory submissions and related regulatory activities, guiding colleagues to thorough and compliant completion. You will also lead ad hoc or special projects to advance Regulatory Affairs capabilities.

Responsibilities

• Represent Regulatory Affairs and may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams
• Oversee and leads regulatory strategies for designated products in the region. This ranges from new product licenses to lifecycle activities.
• Oversee and guides the preparation, compilation, and timely filing of regulatory submissions and approves the authoring of regulatory documents as required and critically reviews documents for submission to regulatory authorities
• Oversee preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensure that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner.
• Oversee and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets. Make significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.
• Partner both within regulatory affairs and throughout the development and commercial organization. Collaborate with cross-functional partners to ensure optimal execution of the agreed regulatory strategy.
• Establish strong relationships with Gilead affiliates and distributor partners and serve as point person for knowledge for their product to these key stakeholders.
• Proactively identify regulatory or related risks/issues and develops mitigation and/or contingency plan.
• Participate and lead collaborative efforts across function in process improvement initiatives.
• Ensure own work complies with established practices, policies and processes, and any regulatory or other requirements.
• Have a good understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence.
• Participate and contribute to regulatory team meetings and be recognized as a knowledgeable resource for Regulatory Affairs in other departments.
• Understand and working knowledge of the use internal electronic systems for planning, preparing, tracking and archiving submissions to regulatory agencies.

Education & Experience

BA/BS or advanced degree in life sciences or related field with regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.

Knowledge & Other Requirements

• In-depth working regulatory knowledge, including ICH and regional requirements.
• An in-depth of current global and regional trends in Regulatory Affairs with proven effectiveness in applying this knowledge to optimize team deliverables.
• Previous experience of working with emerging markets and/or in the Virology therapeutic area would be an advantage but not essential.
• Methodical attention to detail.
• Must have a “can do” attitude and be “hands on” as and when required.
• Proven track record to manage, formulate and execute strategy.
• Strong interpersonal skills and understanding of team dynamics.
• Strong communication and organizational skills.
• Strong negotiation and conflict resolution skills.

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, please apply via the Internal Career Opportunities portal in Workday.

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Education and Training

Industries

• Biotechnology Research and Pharmaceutical Manufacturing