Job Details

Associate Director, Regulatory Affairs CMC

Job Description

We are seeking an Associate Director, Regulatory Affairs CMC candidate to sit at our Foster City, CA site.

Responsibilities:

• The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives.
• Responsible for preparing and/or overseeing the preparation of complex regulatory CMC submissions for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Work collaboratively with cross functional matrix teams to develop a CMC submission plan in accordance with business objectives.
• Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners and CROs) to develop and execute robust CMC regulatory strategies.
• Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Lead the preparation of risk assessments on major global CMC regulatory issues.
• Provides regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises.
• Coordinates and facilitates development of Regulatory CMC strategies with development and commercial project teams, affiliates for local meetings and interactions.
• Proven ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends, and to drive and implement strategic policy decisions.
• Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
• Ensures project teams, line management, and key stakeholders are kept apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Initiates process improvements, contributes to global process improvements, and support the development and maintenance of regulatory templates, best practices, and procedures.
• Coach and mentor junior regulatory CMC RA staff.

Qualifications:

• Requires a Bachelor's degree in a relevant scientific discipline and 10+ years of experience OR
• (Preferred) Requires a Masters degree in a relevant scientific discipline and 8+ years of experience OR
• (Preferred) Requires a PhD in a relevant scientific discipline and 5+ years of experience.
• Candidate must have relevant experience in Regulatory Affairs CMC or other relevant industry experience. Experience in scientific/ technical field is preferred.
• A proven track record of developing global CMC strategies in all phases of drug development including life cycle management.
• Collaborative, proactive, and highly organized approach to work.
• Demonstrated track record with strategic planning, problem solving, and working within a global matrix team environment, successfully managing CMC Regulatory activities and initiatives.
• Deep understanding of global regulatory requirements and guidelines.
• Excellent communication and interpersonal skills.

The salary range for this position is: $182,070.00 - $235,620.00. 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.

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

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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.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.