Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.
Global Regulatory Affairs provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of investigational or approved products.
The Regulatory Associate/Sr. Associate, under the direction of a Global or Regional Regulatory Lead, will assist in the creation and submission of regulatory documents.
• Support and coordinate efforts associated with the preparation of regulatory documents or submissions with Global Regulatory Leads (GRLs), Regional Regulatory Leads (RRLs), and CMC Regulatory Lead
• Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications
• Provide primary authorship to routine regulatory correspondence to maintain IND, IMPD, CTA, NDA and MAAs (including submission TOC, AR, PSUR, PADER, PBRER, DSUR, CCDS, labeling, and IB)
• Create cover letter and forms for applicable submissions
• Complete CTA Questionnaires for all studies on monthly basis
• Create and maintain product regulatory history documents through EDMS and appropriately archive all regulatory documents and agency communications
• Assist the Global or Regional Regulatory Lead and CMC Regulatory Lead, by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label and managing the process for responding to worldwide regulatory agency questions, and tracking and finalization of the RTQs and deliverables globally
• Actively support regulatory compliance and ensure compliance of submissions to regulatory agencies including updates to standard operating procedures, work instructions, or policies
• Participate in global regulatory team (GRT), study team, and ad hoc meetings as a regulatory affairs representative
• Assist GRT meeting management (eg, agendas and minutes for GRTs) to advance regulatory knowledge of the product and processes
• Support the development and execution of department goals Maintain current knowledge of and interpret new regulations, standards, or guidance documents or updates to them
• Coordinate with regulatory publishing and functional team members internally/ externally on applicable submission documents including the drafting, uploading, and routing of documents in EDMS and the review of documents
• Build and maintain spreadsheets that will calculate and organize business metrics as required.
• Other duties as assigned.
Skills & Abilities
• Detail oriented and self-motivator
• Good communication skills - both oral and written
• Organizational skills - detail oriented and can deal with frequent changes in product activity
• Familiarity in Microsoft Office Products
• Excellent listening skills, with an ability to accept direction and feedback
The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.
The physical demands of the office are normally association with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is performed in an office environment.
Travel may be required (up to 10%).
Education & Professional Experience
Minimum of bachelor’s degree required (BA/BS) in a life science or a related discipline required.
Master’s degree in biology, life science, regulatory science or related drug development experience preferred.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Equal Opportunity Employer
Puma Biotechnology Inc is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by law.