BeiGene · 5 days ago
Director, Global Submission Operations Management
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BiotechnologyHealth Care
H1B Sponsorship
Insider Connection @BeiGene
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
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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
BeiGene is a global oncology company.
H1B Sponsorship
BeiGene 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 (28)
2022 (36)
2021 (34)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$6.79BKey Investors
Hillhouse InvestmentAmgen
2020-07-12Post Ipo Equity· $2.08B
2019-10-31Post Ipo Equity· $2.7B
2018-08-02Post Ipo Secondary· $903M
Recent News
2024-06-04
2024-06-04
2024-06-04
Company data provided by crunchbase