Director of Regulatory Affairs
EnergyHubSalary not specified
Director, Global Therapeutic Area Regulatory Liaisons - Oncology at Gilead Sciences
Foster City, California, United States
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
- 12+ years of experience in Regulatory Affairs or other relevant industry experience
- Degree in a scientific field is preferred
Responsibilities
- Act as the Global or Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic area (Oncology)
- Define the regulatory strategy, plans and objectives for assigned products or projects
- Lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams
- Serve as a Gilead contact to/for regulatory authorities
- Oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities
- Play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities
- Help develop the TA's Regulatory leadership pipeline through coaching and mentoring other Regulatory colleagues
- Lead all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures
- Ensure responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidance is met for assigned product(s) and territories
- Prepare and/or manage others’ submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs
- Submit or ensure submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories
- Ensure preparation of the Product Company Core Data Sheets (CCDS), regulatory review of draft Product Company Core Safety Information (CCSI) and ensure that any updates to the CCDS or CCSI are implemented in a timely manner
- Ensure product packaging and associated information is updated and maintained in accordance with the product license
- Act as project team representative and may act as submission team representative for specified products
- Represent Regulatory Function at internal meetings
- Work proactively to build contacts with local Regulatory Authorities
- Participate in industry trade groups and regulatory affairs professional societies
- Maintain knowledge of highly complex regulatory requirements
Skills
Regulatory Strategy
Regulatory Submissions
Oncology
Global Regulatory Affairs
Therapeutic Area Management
Cross-functional Team Leadership
Regulatory Authority Liaison
Regulatory Labeling
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
