Locations: Los Angeles, South San Francisco, Remote
Global Regulatory Affairs provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of investigational or approved products.
The CMC Regulatory Associate/Sr. Associate, under the direction of a Global or Regional CMC Regulatory Lead, will primarily assist in the creation and submission of CMC regulatory documents With appropriate experience, the position will also provide project team regulatory CMC advice, including the interpretation and application of global CMC regulations and guidance, to facilitate the development of products from clinical trials through to worldwide registration, and lifecycle management.
Major Duties/Responsibilities
• Support the preparation of CMC focused regulatory documents or submissions with the Global Regulatory Lead (GRL), Regional Regulatory Lead (RRL), and CMC Regulatory Lead
• Ensure the appropriate CMC regulatory activities occur in support of the timely initiation of global Clinical Trials.
• Serve as a representative on multidisciplinary CMC and study teams.
• Collaborate with CMC and cross-functional groups to plan, coordinate, author, compiling, and/or reviewing high quality regulatory CMC sections of clinical trial or marketing application submission documents while meeting aggressive timelines.
• Plan, coordinate, review and/or write responses to inquiries from regulatory authorities during their review of the submissions.
• Coordinate, plan, and write meeting requests and briefing packages for CMC meetings with regulatory agencies and participate in the meetings as appropriate.
• 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) ) and report key metrics upon request
• 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
• Requesting US CPPs to support marketing applications
• 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 to meet deadlines
• Excellent communication skills - both oral and written and be a team player
• Self-motivated and able to deal with frequent changes in product activity
• Ability to understand and interpret data/information and its practical application
• 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
Physical Demands
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 in Veeva vault
• 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.
The base compensation range for this position is $90k - $120k per year, higher compensation may be available for someone with advanced skills and/or experience.
