Be an early applicantLess than 25 applicants

Company

Original Job Post

Gilead Sciences · 2 days ago

Associate Director, Analytical Regulatory Sciences, Systems & Operations

Foster City, CA

Full-time

Onsite

Director

$178K/yr - $230K/yr

8+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

BiopharmaBiotechnology

H1B Sponsorship

Actively Hiring

Comp. & Benefits

Insider Connection @Gilead Sciences

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Prepares analytical filing content of complex submissions and related supporting activities. Prepares responses to questions from health authorities.

Interprets and implements ICH and regional guidelines with the goal of right first time approval of regulatory control strategies.

Evaluates and implements new regulatory and quality requirements for analytical control strategy in partnership with technical and manufacturing teams.

Evaluates and implements 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 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.

Demonstrates and models Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities.

May participate in business process development initiatives or represent the company in industry consortia.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Masters

Required

Bachelors and 10+ years of experience OR

Masters and 8+ years of experience OR

PhD and 2+ years of experience

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Paid Time Off

Company

Gilead Sciences

Glassdoor

3.9

Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.

Founded in 1987

Foster City, California, USA

10,001+ employees

http://www.gilead.com

H1B Sponsorship

Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (163)

2022 (216)

2021 (218)

2020 (226)