Regulatory Affairs Specialist III # JN -072021-67095

Andover, Massachusetts
Industry: Regulatory
Job Number: JN -072021-67095

Description:

Role Overview

  • The Regulatory Affairs Sr Specialist develops and executes the regulatory submissions plans, ensuring deadlines are met and documents are properly formatted, complete, and in compliance with pharmaceutical/biologics regulatory requirements
  • The Regulatory Affairs Manager will supervise direct reports in submissions activities, reviews and provides feedback on deliverables, and provides leadership, coaching, and performance feedback to direct reports

 

Responsibilities:

  • Prepares regulatory submissions as necessary to meet the Company's product launch timelines, including: drafting, reviewing, and editing of submissions in eCTD format; collection of documentation, formatting and compilation of submission documents 
  • A deep understanding of global regulatory science and overall strategies for complex or novel programs is required (35%)
  • Work closely with project teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company's product launch timelines in all identified markets (35%)
  • Reviews and approves change controls for specification, manufacturing process, labeling and other changes to ensure compliance with FDA and international government requirements, including compliance with cGMP, and GDP requirements (10%)
  • Drafts and maintains applicable policies and procedures to support and define the regulatory affairs function (5%)
  • Performs searches for pertinent changes in regulations and provides notice and summary of the impacts of the change to the business (5%)
  • Compiles and maintains regulatory records for regulatory activities and applications (5%)
  • Performs other duties as assigned (5%)

 

Location:

  • REMOTE: MUST WORK WITHIN CST ZONE HOURS!!!

 

Education:

  • Minimum Bachelor's degree required, focus in the area of chemistry, biology or related science

 

Licenses/ Certifications:

  • Regulatory Affairs Certification (RAC) desired

 

Experience:

  • At least 5 years’ pharmaceutical, biologic, global submissions experience, combination product experience desired
  • Proven experience in leading and developing teams
  • Successful contribution to a major regulatory approval at a global level
  • Must have previous experience in major health authority interactions

 

Competences:

  • Expert knowledge of regulatory affairs within relevant therapy area (pharmaceutical/biologics)
  • Ability to work strategically within a complex, business critical and high-profile programs
  • Ability to think strategically and critically evaluate risks to regulatory activities.
  • Must demonstrate strategic influencing, innovation, initiative, and excellent oral and written communication skills


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