Head of CMC Regulatory Affairs – Strategy and Operations at Gilead Sciences

Foster City, California, United States

Apply Now

Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

PhD or MS with 14+ years of relevant professional experience, or BS with 16+ years of relevant professional experience – a degree in chemistry or a related scientific discipline is strongly preferred
Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives
Experience with CMC requirements for drug development of a range of product modalities
Comprehensive understanding of the biopharmaceutical industry, R&D, and product commercialization, including the regulatory framework
Experience designing, selecting, and implementing digital tools such as RIM, structured content authoring, LIMS, or GenAI applications with an enterprise mindset
Understanding of structured content, automation

Responsibilities

Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget
Own continuous improvement of the operating model and capability roadmap for the CMC RA function
Create and implement functional business strategies
Improve performance and operational excellence
Centralize key activities to support each team’s global product, pipeline, and people’s ambitions
Design, build, and lead a high-performing organization to drive strategic initiatives, centralize activities, and foster cross-functional support of CMC RA’s processes, systems, data, and tools
Define and track Key Performance Indicators for CMC RA
Collaborate with other functions to ensure that CMC RA systems are operating seamlessly connected with the broader enterprise
Partner with Regulatory Affairs, Quality, Technical Development, and Manufacturing stakeholders to align process and digital/data modernization strategies
Support centralized resource management for CMC RA resources defined in Gilead’s resource forecasting system (i.e., Planisware)
Manage CMC RA Operational Excellence activities with a goal of identifying synergies and efficiency across all CMC RA functions to reduce overall spending (responsible for leading the CMCRA leadership thought LRP, budget, etc.)
Manage cross functional teams, internal teams, and complex project teams (NPPs, RA / CMCRA teams, complex programs, etc.)
Oversee digital modernization of core CMC RA platforms (e.g., RIM) and integration across systems
Stand up for CMC RA (with enterprise thinking) and oversee a digital/AI fluency and enablement team aligned to strategic priorities
Create guidelines, systems, and processes for CMC RA knowledge management, in alignment and partnership with any broader initiatives in this space across the enterprise
Lead workforce capability design, training strategy, and upskilling initiatives

Skills

Key technologies and capabilities for this role

CMC Regulatory AffairsRegulatory StrategyOperations LeadershipCapability BuildingBusiness StrategyPerformance MetricsKPI TrackingCross-Functional CollaborationProcess OptimizationSystems ManagementData ManagementOperational Excellence

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What are the key responsibilities or skills needed for the Head of CMC Regulatory Affairs role?

The role requires developing strategy and capability roadmaps, leading operations and cross-functional teams, managing KPIs, partnering with stakeholders like Regulatory Affairs and Quality, and overseeing digital modernization and AI enablement for CMC RA.

What is the company culture like at Gilead?

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.

What makes a strong candidate for this Head of CMC Regulatory Affairs position?

Strong candidates will have experience in strategy development, operational excellence, cross-functional leadership, digital modernization, and managing complex projects in CMC Regulatory Affairs.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free