Director of Regulatory Affairs
EnergyHubSalary not specified
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
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the salary for the Associate Director, Regulatory Affairs CMC position?
This information is not specified in the job description.
Is this a remote position, or what is the location requirement?
This information is not specified in the job description.
What are the main responsibilities for this role?
The role involves serving as a Core member of cross-functional PDM Project Teams, acting as Regional Regulatory Lead, leading Regulatory Submission Teams, participating on Subteams, serving as contact with local Regulatory Authorities, and overseeing preparation of complex regulatory CMC submissions.
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, developmental, and empowering environment where every employee feels included and able to fulfill their aspirations.
What makes a strong candidate for this position?
Strong candidates are passionate, ambitious individuals ready to make a direct impact, with leadership potential to evolve culture and empower teams, suited for roles involving complex regulatory CMC submissions and cross-functional leadership.
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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