PUMA BIO TECHNOLOGY

Position Description

Manager, CMC Regulatory Affairs
Location Los Angeles
Department Regulatory Affairs
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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

 

Summary/Objective

 

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).

 

Essential Functions

  • Ensure the appropriate CMC regulatory activities occur in support of the timely initiation of global Clinical Trials.
  • Planning and coordinating, CMC submissions in support of worldwide clinical and commercial applications for assigned products.
  • Authoring, compiling, and/or reviewing CMC submissions for clinical and commercial applications.
  • Serve as a representative on multidisciplinary CMC teams. 
  • Collaborate with CMC functional groups to plan, write, and prepare high quality regulatory CMC sections of 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.
  • Maintain effective submission archive and report key metrics upon request

 

 

Competencies

  • Bachelor's Degree or equivalent experience in a biotechnology or pharmaceutical company
  • Minimum of 2-5 years of experience within the regulatory environment
  • Knowledge of Veeva vault and Documentum EDMS(s) or other document management system
  • Strong communication skills, proven negotiating skills and be a team player
  • Strong understanding of pharmaceutical development and CMC regulatory affairs
  • Strong ability to prioritize, multi-task, and work in a fast pace and demanding environment
  • Strong critical and logical thinking with ability to analyze problems
  • Ability to work effectively and efficiently under deadlines
  • Ability to manage multiple projects simultaneously
  • Self-motivated and able to prioritize projects in with short lead times
  • Ability to understand and interpret data/information and its practical application

 

Supervisor Responsibilities

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.

 

Work Environment

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.

 

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 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

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

  • Minimum of BS or MS degree in chemical engineering, chemistry, biochemistry or biology.
  • Minimum of 2-5 years of experience within the regulatory environment

Preferred Education & Experience

  • Doctorate degree and 2 years of related experience- or- Master's degree and 4 years of related experience- or- Bachelor's degree and 5 years of direct experience.

Additional Eligibility Qualifications

  • Knowledge of CMC regulatory requirements (FDA, EMEA, ICH, etc.). Proficient in MS office, EDMS, eCTD viewers, etc.
  • Must be knowledgeable in dossier development (IND, IMPD, CTA, NDA, MAA, NDS, etc.) including electronic document submissions (eCTD)
  • Veeva vault and Documentum EDMS(s)
  • Experience in the biotechnology or pharmaceutical industry highly preferred
  • Experience in Oncology highly preferred

 

Other Duties

 

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.

 

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