Senior Director - Analytical Regulatory Science

Description

Senior Director - Analytical Regulatory Science

KEY RESPONSIBILITIES

The Sr Director, Analytical Regulatory Science, is responsible for supervising a team of scientists, who collaborate with product development, manufacturing and quality teams on the construction, documentation and defense of the analytical control strategies in regulatory submissions preparation, review and approval.

By balancing analytical knowledge and evolving regulatory expectations with manufacturing and analytical flexibility the incumbent will support right first time global approvals for CMC control strategies and maintain right to operate throughout the product lifecycle.

In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.

The incumbent will report directly to Head of CMC Regulatory Affairs Systems and Operations at Gilead.

JOB DESCRIPTION

• Drives and supervises team members to drive analytical control strategy development and justification in regulatory filings for projects throughout product lifecycle.
• Guides project teams on preparation of analytical filing content, and participates in authoring and reviewing of complex submissions and responses to questions from health authorities.
• Exercises expertise in the interpretation and implementation of ICH and regional guidelines with the goal of right first time approval of regulatory control strategies.
• Evaluates and drives the implementation of new regulatory and quality requirements for analytical control strategy in partnership with technical and manufacturing teams.
• Promotes continual improvement for analytical control strategies, quality compliance / business processes, and regulatory filing content taking into consideration internal experience and learning from the external environment.
• Ensures conformance to regulatory and quality requirements and internal procedures in the management of filing content and changes.
• Evaluates and communicates risks for CMC control strategies and quality compliance to CMC RA and PDM leadership.
• Develops meaningful and collaborative relationships with cross-functional teams and leaders across CMC RA and PDM.
• Works with CMC RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks.
• Demonstrates success in influencing without positional authority within a highly matrixed organization.
• Mentors and coaches team members to accelerate learning and professional development. Demonstrates and models Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities.
• May have cross-functional leadership roles, and may participate in business process development initiatives or represent the company in industry consortia.

QUALIFICATIONS

• A scientific degree with directly relevant professional experience in analytical chemistry or chemistry, with at least 14 years with a BA / BS or 12 years with an MA / MS, PhD, or PharmD.
• Demonstrated track record defining analytical control strategy approaches for products taking into consideration existing and emerging ICH and regional guidance.
• Experience creating appropriate analytical control strategies attributes through product lifecycle.
• Experience with clinical, premarket and post market submissions preparation including resolution of complex regulatory questions while maintaining manufacturing and analytical flexibility.
• Strong strategic thinking, decision making, prioritization skills, and communication skills (written and verbal) including experience presenting to senior leaders.
• Ability to influence cross-functionally to integrate regulatory and quality thinking and requirements into development plans and activities.

Experience leading or participating in cross-functional initiatives.

• Experience leading or participating in cross-functional initiatives.
• Demonstrated organizational leadership skills at a functional level.
• Demonstrated commitment to creating inclusion, developing talent and empowering teams.

Gilead Core Values

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

The salary range for this position is : $237,660.00 - $307,560.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit :

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States :

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.