Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.
Job Title: Manager, CMC Regulatory Affairs
Department: Regulatory Affairs
Reports to: Director, CMC Regulatory Affairs
The purpose of this position is to provide 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 submission and approval. Responsibilities include supporting the Regulatory CMC function in providing strategic and timely input to questions and issues raised by health authorities, as well as interactions with FDA throughout development phases and post-approval (e.g. face-to-face meetings, teleconferences, briefing documents and contact reports).
This position may manage all employees of the department and is responsible for the performance management and hiring of any employees reporting to this role within that department.
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 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 associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
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 long hours and may require weekend work.
Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected. Travel may be required (up to 10%).
Required Education & Professional Experience
Preferred Education & Experience
Additional Eligibility Qualifications
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.