BeiGene · 3 hours ago
Associate Director, Global Regulatory Process and Compliance
United States
Full-time
Remote
Director/Executive
$143K/yr - $193K/yr
8+ years exp
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Responsibilities
Lead the activities of the Global Regulatory Affairs SOP Committee regarding life-cycle management of Global Regulatory Affairs SOP compliance. To include but not limited to:
Chair the SOP Review Committee to ensure requirements are followed per applicable work instruction.
Assist GRA personnel through the Document Change Process
Guide external personnel to Global Regulatory Affairs to comply with SOP Review Committee requirements
Schedule and conduct adjudication meetings for issue resolution
Manage all applicable trackers/spreadsheets associated with the Global Regulatory Affairs SOP Committee.
Distribute SOP committee monthly reports.
Function as the chair of the Inspection Readiness Team. Leading the team to achieve the following goals (to include but not limited to):
To function as the GRA single point of contact for all notifications of internal audits and Health Authority (HA) Inspections impacting Global Regulatory Affairs (GRA).
To identify and mitigate process gaps that could potentially be considered compliance risks.
To assess GRA CAPAs to determine if the impact of the corrective actions pose a future compliance risk to other regions/functional areas of GRA.
Assist with the planning and coordination of training curricula for the Global Regulatory Affairs team.
Generate Change Management Form for Curricula Owner
Coordinate the modifications with Quality Training
Monitor delinquent training and assist personnel to achieve compliance
Guide managers in assigning their personnel the adequate parameters for on-boarding
Own and ensure the R Reg Affairs Global Reg Process & Compliance curriculum is updated and accurate.
Continuous Monitoring and Reporting
Establish metrics and KPIs to monitor the effectiveness of compliance monitoring and quality management activities.
Collaborate with Quality System record owners to promptly resolve overdue and/or nearly overdue records related to KPI reports.
Consistently provide senior management with reports on the progress of quality initiatives.
Support the global compliance team’s activities as assigned to include serving as liaison to BeiGene compliance activities external to GRA (to include but not limited to):
Information Governance (IG) Team
Clinical Operations Emergency Response Team
Global Standards Committee
Act as the GRA Point of Contact for Quality Initiatives to include but not limited to Quality Training and Quality Document Management Activities. Partner cross functionally with Quality to disseminate Quality Training as reviewed in Quality informational meetings.
Partner with Internal Audit Group to Conduct Gap Analysis
Post audit/inspection support in response to action items generated from the activity.
Assist in procurement of GRA Product Liability Insurance Responses.
Perform other duties as assigned.
Independently lead/participate in GxP compliance activities (internal/corporate, CMO or supplier, CRO) and identify regulatory compliance gaps or risks.
Assess, manage training curricula in response to CAPAs/audits and assess corrective measures for internal and external GxP Compliance audits.
Work with Global Quality Compliance and Regulatory teams to ensure accuracy of compliance data across BeiGene network sites.
Perform duties as assigned to ensure compliance to global and local regulations.
Team to be established including direct reports.
Qualification
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Required
Bachelor of Science degree, in a related scientific discipline or relevant professional certification.
Requires a minimum of 8+ years’ experience in pharmaceutical, biologics, or biotechnology industry, with 5+ years of experience as a Regulatory Affairs compliance lead.
Spoken/Written fluency in English required.
Strong project management skill set.
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint), MS SharePoint.
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeiGene
BeiGene is a global oncology company.
10,001+ employees
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
Represents job field similar to this job
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
Leadership Team
John V. Oyler
CEO & Founder
Aaron Rosenberg
Chief Financial Officer
Recent News
2024-11-19
2024-11-12
Company data provided by crunchbase
