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 primarily assist in the creation and submission of regulatory documents.
* Support the preparation of regulatory documents or submissions with the Global Regulatory Lead (GRL), Regional Regulatory Lead (RRL), and CMC Regulatory Lead
* Coordinate with Regulatory Operations/Publishing and cross-functional team members on submission documents including the drafting, uploading, and routing of documents in Veeva and the review of documents
* Create regulatory submission content plans in Veeva and author the corresponding cover letter and forms
* Working with Regulatory Operations, support the preparation of eCTD/XML formatted regulatory submissions as needed.
* Review key documents (e.g. ICFs, IBs, CSRs, DSURs, etc.) to ensure they are compliant with relevant regulations and guidances (e.g. ICH, FDA, EMA, etc.) prior to submission
* Provide QC support for regulatory submissions
* Support authorship for routine regulatory correspondence to maintain the IND, CTA, NDA and MAAs (including submission TOC, AR, PSUR, PADER, PBRER, DSUR, CCDS, labeling, and IB)
* Support responses to regulatory agency questions
* Create and maintain product regulatory history documents and archive all regulatory documents and health authority communications
* Maintain in house repository for archiving regulatory submissions and health authority correspondence in 21 CFR Part 11 compliant system (e.g., Veeva)
* Assist in the research of regulatory precedent and guidances to help inform the regulatory strategy
* Participate in global regulatory team (GRT), study team, and ad hoc meetings
* Assist with GRT meeting management (e.g., create agendas and minutes)
* Actively support regulatory compliance and ensure compliance of submissions to regulatory agencies including updates to standard operating procedures, work instructions, or policies
* Maintain current knowledge of and help interpret new regulations, standards, or guidances
* Assist with other departmental activities as assigned
Skills & Abilities
* Organizational skills - detail oriented, able to handle multiple projects and exercise good judgement in prioritizing tasks
* Excellent communication skills - both oral and written
* Self-motivated and able to deal with frequent changes in product activity
* Excellent listening skills, with an ability to accept direction and feedback
* Excellent computer skills: MS Word and document management software/system
* Knowledge of 21 CFR and FDA, ICH, GCP, GMP, eCTD, and global guidelines
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
For an Associate / Sr. Associate:
* Minimum of bachelor's degree (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.
For a Sr. Associate:
* 2 to 5 years of experience working in a regulated environment (pharmaceutical, biotechnology)
* Experience with coordinating regulatory submissions, preferably in Veeva
* Experience with eCTD formatted submissions preferred
* Experience with building electronic submissions in compliance with health authority requirements is a plus
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.