79 applicants

Company

BeiGene · 4 hours ago

Associate Manager, Regulatory Operations

Remote (US)

Full-time

Remote

Mid Level

$95K/yr - $130K/yr

4+ years exp

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BiotechnologyHealth Care

H1B Sponsor Likely

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Responsibilities

Partner with cross-functional team members to develop, gain approval and execute on the regulatory strategy/submission plan (specifically for the regulatory submissions in the RoW), and manage the associated timelines, deliverables and resources.

Develop and maintain high level and detailed regulatory timelines that utilize project management software tools, with input from cross-functional team/key stakeholders, ensuring that regulatory timeline are aligned with corporate goals.

Facilitate regulatory team and working group meetings (schedule, prepare / distribute documentation, prepare agendas and meeting minutes, ensure action item follow-up; meeting leadership and discussion facilitation experience required).

Partner with key stakeholders to plan and track regulatory documents for submissions in line with ICH requirements, and other regional requirements and scientific and company policies and procedures.

Facilitate the transparent and timely communication on the submission-related activities and ensure that all stakeholders are fully informed and stay current on the submission activities and their status.

Proactively identify, resolve and escalate issues that may jeopardize project completion on time

Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, and regulatory project management practices.

Qualification

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Regulatory project managementDrug development knowledgePMP certificationProject management toolsMS Office proficiencySelf-awareness

Required

Bachelor’s or higher degree in a related field with 4+ years of experience in (bio)pharmaceutical industries, preferably in regulatory project management, (bio)pharmaceutical project management and/or related discipline.

Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills.

Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers’ expectations.

Accountable for their work; shows initiative and leadership, displaying integrity in everything they do, thriving in a team environment, and seeks excellence as the measure of success.

Must be able to understand and communicate scientific and business elements associated with the therapeutic area(s) of assigned projects.

Moderately proficient with project management tools including Smartsheet, MS project and document management system.

Proficiency with PC utilizing the MS Office suite of applications.

Working knowledge of drug development and regulatory agency regulation, guidelines, and submissions.

Self-directed individual; works independently and collaboratively with direction in matrix organization.

Preferred

PMP or similar certification preferred.

Proficient with project management tools (Microsoft Project, Smartsheet, etc).

Benefits

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

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

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

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Trends of Total Sponsorships

2023 (28)

2022 (36)

2021 (34)

2020 (22)