Manager, Regulatory Project Management (Temporary)

  • Temporary Worker - Full Time (Agency) - TFT
  • Anywhere
  • Posted 3 months ago

JOB DESCRIPTION:

Reporting to Heron’s Associate Director of Regulatory Project Management, and in collaboration with Heron’s Regulatory Strategy and Regulatory CMC functions, plan, manage and track regulatory filings to health authorities in the US, EU, Canada, and other regions.  Works with senior Regulatory Affairs staff and key submission contributors from other Heron functions during the planning and execution of submissions to ensure contents are complete and correct per regulations and guidance, and that submissions are filed to health authorities on time and according to Heron’s business objectives.

ESSENTIAL DUTIES & RESPONSIBILITIES:

Under minimal supervision, prepare maintenance submissions to IND and marketing applications to the US FDA and other health authorities.
Partner with other Heron functions – including Program Management, Medical Writing, Regulatory Strategy, Regulatory CMC, Clinical Operations, Biostatistics, and Translational Sciences – to prepare and actively manage timelines for large and/or complex submissions including agency briefing documents, original applications, information amendments, and supplements.
Work with Regulatory Strategy function to develop and update key product labeling documents including package inserts, instructions for use, and core data sheets.
Serve as primary interface between Heron Regulatory Affairs and Regulatory Operations, communicating when documents are approved and/or revised, reviewing and/or coordinating review of published output, and providing feedback.
Review critical documents for submission to health authorities, in order to confirm adherence to recognized standards and appropriate regulations and procedures.
Serve as primary interface with Heron Clinical Operations to ensure appropriate documentation is submitted to FDA and other health authorities during the startup and throughout execution of clinical trials.
Ensure registration of clinical trials and posting of results to registries such as ClinicalTrials.gov is completed per health authority requirements.
As needed, lead or participate in process improvement initiatives (e.g., SOP development, process development).

REQUIREMENTS:

Bachelor’s degree in scientific discipline.
5 years of work experience in the pharmaceutical, biotechnology, or medical device industries, preferably in Regulatory Affairs, Quality Assurance, or a related discipline.
Ability to coordinate maintenance submissions to regulatory applications with minimal supervision.
Ability to independently read and understand health authority guidelines and communicate their impact to team members representing various Heron functions.
Proven ability to work with a cross-functional team to plan and manage regulatory deliverables, while interfacing with Heron R&D functions and Corporate Project Management.
Working knowledge of US regulations guidance’s related to IND and NDA applications and their maintenance.
Working knowledge of relevant ICH guidelines and of electronic common technical document requirements.
Proficient computer and word processing skills and electronic document management systems (such as Veeva).
Strong attention to detail and organization skills.
Strong written communication skills and interpersonal skills.
 

 

 

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all-inclusive or limit the duties of the position.

 

Heron is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity.

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