Senior Associate, US Regulatory Affairs

BeiGene

1d•$93,600 - $123,600•Onsite

About The Position

BeOne is seeking an experienced and energetic person to manage, evaluate, and complete 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 Sr Associate 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.

Requirements

BA / BS in Health Science, preferred, with at least 2+ years’ experience in the pharmaceutical industry
Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical)
Experience with CTD/eCTD.
Experience with publishing documents in Adobe Acrobat Professional.
Working knowledge of FDA and ICH regulatory guidance and regulations
Understanding of FDA structure and function.
Knowledge/experience with regulatory requirements for other regions also desirable
Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle.
Excellent oral and written communications skills are a must as are superior planning skills
The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment

Responsibilities

With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC
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