Job Title:
Executive Director, Regulatory Affairs Labeling Client:
Gilead Sciences International, Ltd. Location:
Cambridge, United Kingdom Job Category:
Other EU work permit required:
Yes Job Reference:
48709b5ee874 Job Views:
54 Posted:
22.01.2025 Expiry Date:
08.03.2025 Job Description:
FUNCTION:
Regulatory Affairs (RA) Labeling POSITION OVERVIEW: Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. You will lead and oversee the Global Regulatory Affairs (GRA) Labeling organization, inclusive of labeling strategy and labeling operations/compliance. You will provide strategic input and operational leadership and management oversight of regulatory labeling across Gilead's product portfolio. EXAMPLE RESPONSIBILITIES: Leads the GRA Labeling function to ensure compliance with evolving global regulatory requirements. Leads a team of labeling strategists responsible for managing core labeling and US labeling. Accountable for driving effective and integrated cross-functional governance. Oversee the development and management of implementation of global labeling and review processes. Accountable for Gilead labeling activities, including representing the function during audits and inspections. Hires, develops, and retains diverse top talent. Ensures timely, high-quality labeling documents in collaboration with stakeholders. Leads Global Safety and Labeling Committee (GSLC) labeling governance discussions. Owns and manages the resource plans, performance, and budget for the GRA Labeling function. Drives digital innovation across the global labeling value chain. REQUIREMENTS: PharmD/PhD/MA/MS/MBA/BA/BS with significant relevant experience in prescription drug labeling. Strong experience leading development of regulatory labeling strategies, and representing Regulatory to cross-functional leaders. Significant experience in global prescription drug labeling across multiple markets. Proven ability to influence up, down, and across the organization. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. to recruit and employ the most qualified persons available for positions throughout the Company.
#J-18808-Ljbffr
Executive Director, Regulatory Affairs Labeling Client:
Gilead Sciences International, Ltd. Location:
Cambridge, United Kingdom Job Category:
Other EU work permit required:
Yes Job Reference:
48709b5ee874 Job Views:
54 Posted:
22.01.2025 Expiry Date:
08.03.2025 Job Description:
FUNCTION:
Regulatory Affairs (RA) Labeling POSITION OVERVIEW: Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. You will lead and oversee the Global Regulatory Affairs (GRA) Labeling organization, inclusive of labeling strategy and labeling operations/compliance. You will provide strategic input and operational leadership and management oversight of regulatory labeling across Gilead's product portfolio. EXAMPLE RESPONSIBILITIES: Leads the GRA Labeling function to ensure compliance with evolving global regulatory requirements. Leads a team of labeling strategists responsible for managing core labeling and US labeling. Accountable for driving effective and integrated cross-functional governance. Oversee the development and management of implementation of global labeling and review processes. Accountable for Gilead labeling activities, including representing the function during audits and inspections. Hires, develops, and retains diverse top talent. Ensures timely, high-quality labeling documents in collaboration with stakeholders. Leads Global Safety and Labeling Committee (GSLC) labeling governance discussions. Owns and manages the resource plans, performance, and budget for the GRA Labeling function. Drives digital innovation across the global labeling value chain. REQUIREMENTS: PharmD/PhD/MA/MS/MBA/BA/BS with significant relevant experience in prescription drug labeling. Strong experience leading development of regulatory labeling strategies, and representing Regulatory to cross-functional leaders. Significant experience in global prescription drug labeling across multiple markets. Proven ability to influence up, down, and across the organization. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. to recruit and employ the most qualified persons available for positions throughout the Company.
#J-18808-Ljbffr
