Senior Director, Regulatory Affairs
Abata TherapeuticsSalary not specified
Senior Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence at Gilead Sciences
Dublin, County Dublin, Ireland
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
- Act as Franchise Lead for Regulatory Affairs at the Pediatric Center of Excellence
- Provide leadership and mentorship for direct reports
- Oversee and guide development and execution of regulatory strategies, plans, and objectives for pediatric development across Virology, Oncology, and Inflammation therapeutic areas, aligned with global product development
- Oversee development of global pediatric regulatory plans and preparation of pediatric regulatory submissions
- Monitor progress and completion of global pediatric commitments
- Guide and advise colleagues in thorough and compliant completion of regulatory activities
- Act as Global Regulatory Lead and/or Gilead contact to/for regulatory authorities as needed
- Serve as senior regulatory representative and pediatric subject matter expert to cross-functional leaders and teams
- Play leadership role on regulatory leadership teams at the Pediatric Center of Excellence
- Participate in ad hoc or special projects/initiatives to improve or advance GRA capabilities
Responsibilities
- Accountable for oversight and leadership of the development and successful completion of global pediatric regulatory strategies, submissions, documents, activities, and other deliverables for products across Virology, Oncology, and Inflammation therapeutic areas to achieve strategic milestones and objectives
- Make significant contributions to the ongoing development and optimization of pediatric regulatory strategies, processes, standards, and practices in collaboration across Global TA regulatory liaisons
Skills
Regulatory Affairs
Global Regulatory Strategy
Therapeutic Area Liaison
Drug Development
Regulatory Agency Interactions
Licensure Management
Regulatory Filings
Cross-functional Collaboration
Pediatric Regulations
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