[Hiring] Associate Manager, Regulatory Affairs @BeiGene

Role 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.

• 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/CROs as required.

Qualifications

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

Requirements

• Computer Skills: Word, Excel, PowerPoint.

Benefits

• Medical, Dental, Vision.
• 401(k), FSA/HSA.
• Life Insurance.
• Paid Time Off.
• Wellness programs.
• Annual bonus plan for non-commercial roles.
• Incentive compensation plan for commercial roles.
• Opportunity to own shares of BeOne Medicines Ltd. stock.
• Eligibility for discretionary equity awards.
• Voluntary participation in the Employee Stock Purchase Plan.

Company Description

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. The listed range reflects the base salary or hourly range only.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].