80 applicants

Company

Original Job Post

BeiGene · 3 days ago

Director, Global Submission Operations Management

United States

Full-time

Remote

Director

$166K/yr - $226K/yr

10+ years exp

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BiotechnologyHealth Care

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Responsibilities

Interact with BeiGene's Senior Management to create, review, and approve submission dossiers for regulatory Health Authority review.

Provide leadership to Regulatory Submissions Operations Management teams in establishing submission timelines and deliverables.

Develop Submission Operations personnel to enable active participation in project teams and submission planning meetings.

Contribute to building a high performing team within the Regulatory Operations organization.

Provide guidance on submission standards, quality processes, and support electronic/paper submission publishing.

Act as a Subject Matter Expert for global processes supporting submission publishing and quality control checks.

Engage with industry experts and regulatory agencies on new guidance and regulations impacting submissions and related technology/systems.

Manage external vendors on expectations, timelines, and quality of work.

Serve as a primary lead on global programs within R&D and Global Regulatory Affairs.

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.

CTD/eCTDFDA regulationsEMA regulationsICH regulationsRegulatory submissionProblem-solvingHard-workingDetail-oriented

Required

Bachelor's Degree required with minimum of 10 years of Regulatory Operations experience in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 6 years’ experience in a regulatory operations leadership role.

Experience and knowledge with CTD/eCTD and working knowledge of FDA, EMA and ICH regulatory submission guidance and regulations.

Excellent oral and written communications skills.

Superior planning skills.

Detail-oriented and a self-starter.

Comfortable with broad responsibilities in an entrepreneurial, fast-paced, company environment.

Preferred

Master's Degree preferred.

Benefits

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Equity Awards

Employee Stock Purchase Plan

Company

BeiGene

Glassdoor

3.1

BeiGene is a global oncology company.

Founded in 2010

Cambridge, Massachusetts, USA

10,001+ employees

https://www.beigene.com

H1B Sponsorship

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Trends of Total Sponsorships

2023 (28)

2022 (36)

2021 (34)

2020 (22)