Associate Director, Regulatory Affairs CMC at Gilead Sciences

Tokyo, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Serves as Core member of cross-functional PDM Project Team (region specific)
Acts as Regional Regulatory Lead on Regulatory Project Teams
Serves as Regional Lead and may lead cross-functional/cross-regional Regulatory Submission Teams
Participates on other Subteams, as applicable
Serves as contact with local Regulatory Authorities
Some positions may include oversight of computerized systems
Up-to-date knowledge of regulatory CMC requirements

Responsibilities

Prepares and/or oversees preparation of technically complex regulatory CMC submissions requiring interaction with departments outside Regulatory Affairs CMC for investigational and commercial products, in line with ICH requirements, regional requirements, and company policies (e.g., supplements, license renewals to clinical trial applications and marketing authorizations, CTNs for assigned territories)
Provides strategic regulatory CMC advice as appropriate
Oversees preparation and maintenance of country-specific labeling and product packaging (region specific)
Coordinates and facilitates development of regional Regulatory CMC strategy with affiliates for local meetings and interactions
Ensures up-to-date knowledge of regulatory CMC requirements and communicates relevant changes to project teams and senior management in a timely manner
Initiates local process improvements and contributes to local and/or global process improvements with significant impact for Regulatory Affairs CMC Department or other departments
Plans, schedules (description cuts off here)

Skills

Regulatory Affairs

CMC

FDA Regulations

Pharmaceutical Development

BLA Submissions

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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