Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.
The purpose of this position is primarily to support US regulatory aspects of regulatory affairs for Puma’s lead product, research & summarize regulatory intelligence, provide regulatory input for regulatory submissions and work closely with colleagues to compile & review submissions for completeness and quality.
• Participates in global regulatory team, study teams, and ad hoc meetings as a regulatory affairs representative.
• Offer input on submission strategies and identifies potential regulatory risks and mitigation solutions
• FDA contact for assigned projects as appropriate
• Tactical support for the timely preparation, editing and review of submissions, including Health Authority Meeting Requests & Briefing Documents, IND/CTA amendments, NDAs/NDSs/MAAs and their respective amendments/supplements
• Support creation of cover letters, forms, and other required documentation for applicable submissions including drafting of proposed US labels.
• Liaises internally and externally on applicable submission documents including the uploading and routing of documents in Veeva and the review of documents.
• Assist in the global regulatory strategy for potential new markets and regulatory intelligence for indications of interest.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• Provide interpretation of new regulations, guidance documents and directives; and advises on impact on internal programs.
• Project manage and support Global MAA with Regional Partners and ex-US CTAs through local regulatory consultants
• Compile and maintain global regulatory documentation databases or systems.
• Archive global submissions and regulatory correspondence.
• Complete CTA Questionnaires for all studies on monthly basis.
• Build and maintain spreadsheets that will calculate and organize business metrics as required.
• Compose or update standard operating procedures, work instructions, or policies as needed.
• Other duties as assigned.
• Detail oriented and self-motivator
• Experience working in and leading teams
• Familiarity in Microsoft Office Products
• Excellent listening and communication skills, with an ability to accept direction and feedback
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.
This position may manage employees of the department and is responsible for the performance management and hiring of any employees reporting to this role within that department.
Required Education & Experience
• Minimum of Bachelor’s degree
• Degree(s) should be in Life Sciences/Health Related Sciences from an accredited college or university
• Had prior US Regulatory Lead, FDA contact, or directly related experience, preferably in the oncology therapeutic area
Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m. This position regularly requires extended hours and may require weekend work.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
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 is primarily local during the business day, although some out-of-area and overnight travel may be expected. Travel may be required (up to10 %).
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.