Associate Manager, Regulatory Affairs

BeiGene

1d • $103,000 - $138,000

About The Position

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Regulatory affairs Associate Manager manages, evaluates, and completes regulatory projects consistent with company goals. This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. The Associate manager will assist the Regulatory Affairs team member on cross-functional project teams and will assist on authoring and preparation of annual reporting and will manage regulatory submissions and regulatory archive. Essential Functions of the job: With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical and non-clinical. Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects. Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad. Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents. Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and provide expertise on regulatory matters. Develop and maintain current regulatory knowledge and advise management of significant developments. Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO’s as required.

Requirements

• BA / BS in Health Science, preferred, with 4+ years of experience in the pharmaceutical industry.
• Word, Excel, PowerPoint

Responsibilities

• Plan and manage regulatory activities related to assigned projects that span technical areas including clinical and non-clinical.
• Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
• Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad.
• Ensure regulatory submissions are maintained in compliance with regulatory requirements.
• Support and manage preparation of meeting requests and briefing documents.
• Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc.
• Participate on project teams and provide expertise on regulatory matters.
• Develop and maintain current regulatory knowledge and advise management of significant developments.
• Prepare and maintain regulatory archive.
• Work with external regulatory consultants/CRO’s as required.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees