200+ applicants

Company

BeiGene · 2 days ago

Director, Global Regulatory Lead

United States

Full-time

Remote

Director/Executive

$166K/yr - $226K/yr

10+ years exp

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BiotechnologyHealth Care

H1B Sponsor Likely

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Responsibilities

Provides high level global strategic and operational regulatory direction and leadership on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.

Uses extensive knowledge of global regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.

Supports the preparation and submission of global regulatory documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met including the review global submission documents in support of clinical trials and marketing applications, and their amendments to support investigational and marketing registration packages throughout the world.

Supports regional team to negotiate with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.

Maintains awareness of global regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of global regulation.

Integrates functional expertise with business knowledge to solve problems and makes good decisions for the overall business.

Manages and leads an effective global regulatory project team via indirect reporting structure.

Builds partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.

Manages critical issues, taking leadership for the regulatory contribution.

Responsible for assisting with the development and implementation of regulatory processes.

Mentors regulatory professionals and helps create a goal oriented culture.

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.

Regulatory AffairsDrug Development ProcessINDs/CTAsNDAs/BLAsCross-functional Team LeadershipGlobal Regulatory StrategyBusiness AcumenPC Literacy

Required

BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience in the biotechnical or pharmaceutical industry, and 5+ years of experience in a Regulatory capacity with broad and in-depth regulatory knowledge and substantial working experience.

Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends.

Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading cross-functional regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.

Strong business acumen and ability to make sound decisions that contribute positively to the business.

Strong strategic skills including creativity and effectiveness in identifying and addressing strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.

Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.

Excellent interpersonal, oral and written communication skills. Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders.

Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.

Strong negotiating skills and ability to think creatively and develop innovative solutions.

Proven ability to build trust and respect within the organization.

Ability to prioritize and handle multiple projects simultaneously.

Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Ability to work on a computer for extended periods of time

Must be willing to travel approximately 10-20%

Preferred

Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with both small molecules and biologics.

Has sufficient regulatory knowledge to integrate inputs from other countries/regions to develop a global strategy and can develop and lead execution of holistic regulatory strategy while considering risk/opportunity, timeline, resource.

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

10001+ employees

https://www.beigene.com

H1B Sponsorship

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2023 (28)

2022 (36)

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2020 (22)