Sr Regulatory Affairs Associate at Gilead Sciences

Sao Paulo, Sao Paulo, Brazil

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Pharmacist / Biochemistry degree
Extensive experience in the pharmaceutical/biotechnology industry and in particular R&D companies
Fluent in English
Extensive knowledge and proven experience on post-registration changes / line extensions / labeling updates regulations, including the new API framework
Extensive experience in small molecules regulation and desirable experience in biologics regulation

Responsibilities

Support the definition, development and execution of regulatory strategies for maintenance of registered products, including variations, line extensions, labelling updates, renewals and annual reports
Manage GMP applications and renewals; maintenance of legal documents (operating license and CRF)
Manage labeling and artwork updates
Support monitoring competitors as part of the regulatory intelligence activities
Provide proper regulatory advice to main stakeholders considering business needs and assuring no commercialization disruption due to variations, as applicable
Monitor regulations and changes in the regulatory environment and participate on discussions related to regulation changes (Trade Associations, ANVISA) in order to keep the internal stakeholders updated on potential risks and opportunities that could impact ongoing and future projects
Lead internal discussions and projects to support public consultations to capture Gilead´s contributions for shaping the regulatory environment and, for new regulations, support and assure the implementation of Brazilian requirements
Review and approve promotional and non-promotional materials according with local regulations, ethics code and Gilead´s business conduct
Support local processes improvements and contributes to local and/or global processes improvements which have a significant impact for RA and other departments; assess proposed changes to local procedural documents and impact on existing process

Skills

Regulatory Affairs

Regulatory Compliance

CMC

Supply Chain

Quality Assurance

Cross-functional Collaboration

Negotiation

Portfolio Maintenance

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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