Sr. Associate, Regulatory Affairs
Company: Puma Biotechnology
Location: Los Angeles
Posted on: January 28, 2023
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Job Description:
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.
Major Duties/Responsibilities
* 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
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, 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.
The base compensation range for this position is $80K - $100K. per
year, higher compensation may be available for someone with
advanced skills and/or experience.
Keywords: Puma Biotechnology, Los Angeles , Sr. Associate, Regulatory Affairs, Other , Los Angeles, California
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