Regulatory Affairs Director at Gilead Sciences

Beijing, China

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s degree or higher in Pharmacy, Life Sciences, Medicine, or a related scientific field; advanced degree (Master’s or PhD) preferred
Minimum of 15 years of progressive experience in pharmaceutical regulatory affairs
At least 8 years focused on oncology drug development and registration in China
Strong track record of leading successful NDA/BLA submissions and managing NMPA review processes

Responsibilities

Lead the development and implementation of comprehensive regulatory strategies for assigned products and programs in oncology and inflammation, from pre-IND/IND, NDA/BLA through approval and post-marketing phases, ensuring alignment with global plans and local regulation requirements
Serve as the China Affiliate Regulatory TA Lead for complex or high-priority molecules, indications, or development programs, providing strategic input to cross-functional teams including Clinical Development, CMC, Pharmacovigilance, and Commercial
Drive end-to-end NDA/BLA submissions and regulatory approvals, including leading cross-functional teams in dossier preparation, responding to HA questions, managing RTQ processes, and supporting inspection readiness
Lead and manage all interactions with CDE/NMPA and other local health authorities, including pre-IND, pre-NDA, major milestone meetings, and ad hoc communications; act as the primary regulatory point of contact for regulatory authorities in China
Oversee timely and compliant submission of clinical trial applications, amendments, annual reports, and other trial-related documents to ensure uninterrupted clinical development
Guide the preparation of key regulatory documents, including briefing packages, meeting requests, responses to information requests, and risk-benefit analyses
Proactively monitor and interpret evolving local regulatory requirements, guidance, and policies, and ensure rapid integration into China regulatory strategies; contribute to shaping new regulations through constructive engagement
Provide regulatory input into promotional materials review and lifecycle planning, ensuring compliance with approved labeling and local advertising regulations
Represent Regulatory Affairs in cross-functional brand teams and internal governance committees, contributing to product positioning and launch readiness
Mentor and guide junior regulatory staff; champion regulatory excellence and continuous improvement initiatives across processes, systems, and tools
Stay ahead of competitor landscape and regulatory trends in China, providing insights that inform strategic decision-making
Maintain close collaboration with global key stakeholders, such as GRL, GDL, and PSL, to provide timely China regulatory input and ensure alignment between local strategy and global development plans

Skills

Key technologies and capabilities for this role

Regulatory StrategyNDA/BLA SubmissionsINDCDE InteractionsPharmacovigilanceCMCOncologyInflammationHA InteractionsInspection ReadinessCross-Functional Leadership

Questions & Answers

Common questions about this position

What is the employment type for this Regulatory Affairs Director position?

The position is full time.

Is this Regulatory Affairs Director role remote or office-based?

This information is not specified in the job description.

What are the key responsibilities or skills required for the Regulatory Affairs Director role?

Key responsibilities include leading regulatory strategies for oncology and inflammation products from pre-IND to post-marketing, serving as China Affiliate Regulatory TA Lead, driving NDA/BLA submissions, managing interactions with CDE/NMPA, and overseeing clinical trial applications.

What is the company culture like at Gilead Sciences?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with people leaders driving an inclusive culture where employees feel developed and empowered; every team member plays a critical role in scientific innovations.

What makes a strong candidate for the Regulatory Affairs Director position at Gilead?

Strong candidates should have expertise in leading regulatory strategies for oncology and inflammation in China, experience with CDE/NMPA interactions, NDA/BLA submissions, and the ability to provide strategic input to cross-functional teams.

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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