Director – Regulatory Affairs – Global Labeling

Director – Regulatory Affairs – Global Labeling

Requirements

• PharmD/PhD with 6+ years’ relevant experience.
• MA/MS/MBA with 10+ years’ relevant experience.
• BA/BS with 12+ years’ relevant experience.
• 6+ years’ experience in prescription drug labeling.
• Significant experience leading development of regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple medicinal products.
• Proven track record in effectively setting and directing the regulatory labeling or related strategy to successful conclusion for one or more products.
• Significant experience working with a broad array of regulatory labeling documentation and processes, including core data sheets, prescribing information, and target product labels for both marketed and investigational products.
• Significant experience in NDA/BLA labeling and labeling negotiations.
• Strong track record of successes working and negotiating with regulatory authorities.
• Global prescription drug label experience: U.S., EU, and potentially more.
• Extensive experience participating in cross-functional projects and teams.
• Proven track record of effective people leadership as evidenced through cross-functional team engagement.
• Proven track record of successfully managing large scale, complex, time-sensitive projects.

Responsibilities

• Individual contributor, with potential leadership opportunities to mentor and coach others, and may manage team member(s).
• May be a standing member of the RA Labeling Leadership Team.
• Leads development of the labeling strategy for multiple products and indications.
• Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across one or more therapeutic areas.
• Provides strategic advice and guidance to cross-functional partners and stakeholders.
• Leads and facilitates cross-functional labeling and related forums and meetings, such as CLWG, TPL, and USPI team meetings.
• Leads or otherwise contributes to key system and process improvements.
• Represents or otherwise oversees other team members representing RA Labeling on RA Project Teams, at cross-functional submission team meetings, and on joint labeling / safety meetings with partner companies.
• Oversees and guides CCDS/USPI review, approval, distribution, and tracking. Ensures updates to the CCDS are implemented in the USPIs.
• Performs team and/or final review of ex-U.S. labeling, including reference market labeling and dependent market labeling as needed. Provides strategic input on ex-US labeling.
• Manages complex labeling negotiations with regulatory authorities.
• Coaches and advises less experienced colleagues in completing their work and developing their regulatory capabilities.
• Leads or otherwise contributes to special projects that advance the capabilities of Regulatory Affairs.
• Trains other RA Labeling colleagues or cross-functional team members in various matters relating to RA labeling.
• Ensures the team and the assigned work comply with established practices, policies, and processes and any regulatory or other requirements.

Preferred Qualifications

• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.