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Manager, Regulatory Affairs
Avalyn Pharma
 
Job Location: Seattle, WA
Location: Seattle, Washington, 98101, United States
Posted: 2021-02-09
Position Title: Manager, Regulatory Affairs
Company Name: Avalyn Pharma
Sector: Executive/Management
Job Type: Full-Time
Min Education: BA/BS/Undergraduate


Avalyn Pharma is a growing biopharma company committed to developing improved therapies for the treatment of idiopathic pulmonary fibrosis (IPF) and other severe respiratory diseases.

The Manager, Regulatory Affairs will focus on overseeing regulatory affairs for Avalyn's clinical programs. This position will report to the Senior Vice President, Clinical Development Operations and will be located in the Seattle office. The Manager will ensure compliance with regulations pertaining to conducting clinical trials. This position will manage regulatory submissions and will oversee documentation to ensure compliance with domestic and international regulations and standards. The Manager will participate as an active member of the Avalyn development team to plan and manage the regulatory tasks required for phase 1 - 4 clinical studies.


Responsibilities and Duties:

  • Ensure all clinical trials are executed in compliance with domestic and international GCP guidelines/regulations and applicable SOPs
  • Oversee coordination and planning of interactions, communications and submissions to regulatory authorities and ethics committee, as
  • Provide oversight of CRO and consultant activities performed for Avalyn's clinical programs as related to regulatory submission activities, including management of submission strategy and timelines, as well as identification and resolution of any performance issues
  • Participate in development and writing of INDs, protocols, Investigator Brochure(s) and other relevant clinical trial documents Direct the preparation and submission of regulatory agency applications, reports and correspondence
  • Oversee documentation to ensure compliance with domestic and international regulations and standards
  • Identify requirements for submissions ensuring accuracy, consistency and completeness while adhering to regulatory standards, SOPs and work guidelines as required
  • Develop, manage and maintain regulatory affairs SOPs; implement regulatory affairs policies and procedures to ensure regulatory compliance is
  • Participate in evaluation of system for internal file storage and controlled document management
  • Participate in the development of departmental timelines and budgets, as well as review and approval of relevant vendor invoices
  • Functional representative on project teams, study teams, including multi-disciplinary interactions




Required Knowledge, Skills and Abilities:

  • Proven organizational skills with the ability to prioritize and work well in an environment with competing demands
  • Experience in and knowledge of industry regulations and requirements pertaining to clinical trials
  • Strong, interpersonal, motivation and negotiation skills with an ability to communicate effectively at all levels
  • Knowledge of ICH, GCP, Data Privacy and other applicable regulations and requirements in the pharmaceutical industry
  • Strong influence and relationship building ability
  • Ability to plan, organize and monitor activities according to priorities, established schedules and deadlines
  • Ability to adapt to small-company hands-on culture
  • Ability to work under pressure
  • Proficiency in Microsoft Office (Excel, Word, Microsoft Project, PowerPoint) or relevant Project Management software


Qualifications:

  • Bachelor's degree in biological sciences or relevant field, Master's degree a plus
  • Minimum of 5 years of work experience in the pharmaceutical industry
  • Knowledge and hands on experience in regulatory inspections
  • Experience working on phase 1 - 4 clinical studies within the medical device and/or pharmaceutical industry


Other Requirements:

  • Occasional day and overnight travel is required to attend training, conferences, meetings or visit vendors (up to 25%).
  • Additional duties may be assigned, and evenings, weekend and holiday work may be required
  • Due to Covid-19 precautions, this role is temporarily remote, but will be expected to return to Avalyn office once it is deemed safe for all staff to return to the office




PI130191168





 
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