Associate Director Regulatory Affairs CMC
Associate Director Regulatory Affairs CMC
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$ 182070 - 235620
1 Vacancy
Job Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
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 CMCrelated 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 andsupport the development and maintenance of regulatory templates best practices and procedures.
- Coach and mentor junior regulatory CMC RA staff
Qualifications:
- Requires a Bachelors 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 strategiesin 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
For additional benefits information visit:
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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 disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
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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.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Required Experience:
Director
Employment Type
Full-Time
