Regulatory Affairs Assoc II CMC at Gilead Sciences

Cambridge, England, United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Ph.D., Masters or Bachelor’s in pharmacy, chemistry or related field with experience working in scientific/technical group within a pharma company
Experience with small molecule/synthetic pharmaceuticals (preferred)
Collaborative, proactive, and highly organized approach to work
Demonstrated track record with strategic planning, problem solving, and working within a global matrix team environment
Good understanding of the drug development process
Excellent verbal and written communication skills and ability to interact well with colleagues

Responsibilities

Provides support for designated regional regulatory activities for PDM CMC Project and Commercial Teams, Regulatory Project and Regulatory Submissions Teams, with focus on Small/Synthetic Molecules
Assists designated CMC RA leads in identifying and ranking risks, proposing risk mitigation plans. Shadows leads while they develop and execute robust CMC regulatory strategies
Under the guidance of more senior staff, oversees the preparation of CMC regulatory submissions for investigational and commercial products with solid scientific foundations, in compliance with ICH and regional requirements, and in alignment with company policies and procedures
Becomes proficient in utilizing computerizing systems as per established business processes, both within and outside of the GxP environment
Trains and learns how to prepare regulatory submissions which require some interactions with other members in the CMC regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures
Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the CMC regulatory department
Participates in group meetings and provides tactical approaches to addressing issues of low to moderate complexity
May participate in other Subteams and in non-product related projects; may contribute to local process improvements, which have an impact on the working of the CMC Regulatory function or other departments
Learns how to interpret regulatory guidelines and how to comply with statutory requirements
Learns how to provide regulatory impact assessments for changes managed in the quality systems and participates in technical risk assessment exercises
Proactively invests in own development to acquire regulatory skills and knowledge, with manager support
Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and regulatory trends

Skills

CMC

Regulatory Affairs

Small Molecules

Synthetic Molecules

ICH

Regulatory Submissions

Risk Mitigation

Regulatory Strategy

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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