Associate Director, Regulatory Affairs - Oncology at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, OncologyIndustries

Requirements

10+ years of experience in Regulatory Affairs or other relevant industry experience
Degree in a scientific field is preferred
Excellent verbal and written communication skills and interpersonal skills
In-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories
In-depth understanding of current global and regional trends in Regulatory Affairs
Capable of developing and implementing regulatory strategy
Capable of managing complex negotiations with Regulatory Authorities
Capable of leading a small team in preparation of submissions and maintenance of licenses
Demonstrated ability to act as primary Company contact with Regulatory Authorities
Previous people management experience

Responsibilities

Preparing and/or overseeing the preparation of technically complex regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures
Directing others in accomplishing Corporate Objectives
Submitting complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories
Preparation of the Company Core Data Sheets (CCDS) for assigned products
Contributing to the regulatory review of draft Product Company Core Safety Information (CCSI) and ensuring updates to the CCDS or CCSI are implemented
Ensuring product packaging and associated information is updated and maintained in accordance with the product license
Providing strategic regulatory advice as appropriate
Maintaining knowledge of regulatory requirements up to date and communicating changes in regulatory information to project teams and senior management in a timely manner
Initiating local process improvements and contributing to local and/or global process improvements, which have a significant impact for the Regulatory Affairs Department or other departments
Planning, scheduling and arranging own activities and those of direct reports (if applicable)
Assuming a leadership role in updating and preparing the Company for minor changes in legislation in assigned territories and actively participating in a broader cross functional team for implementation of major changes
Acting as a knowledgeable resource for Regulatory Advice in other departments

Skills

Regulatory Affairs

Regulatory Submissions

ICH Guidelines

Clinical Trial Applications

Marketing Authorizations

Safety Reports

Amendments

Supplements

License Renewals

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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