Regulatory Affairs Specialist

  • location: Exton, PA
  • type: Permanent
  • salary: $70,000 - $72,000 per year
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job description

Regulatory Affairs Specialist

job summary:
This role is responsible for coordinating and authoring regulatory submissions for products and processes. Address customer regulatory requests and maintain knowledge of current US and international regulations/guidelines/policies applicable to our products and services.

 
location: Exton, Pennsylvania
job type: Permanent
salary: $70,000 - 72,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Complete regulatory assignments with guidance in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of CMC dossiers [DMFs, MAFs, 510(k)'s], for submission to Health Authorities in compliance with regulations, guidelines and procedures; Ensure dossiers remain accurate as filed with Health Authorities
  • Review technical project documentation, certifications, correspondences, and external communications, as needed.
  • Create documentation in response to customer regulatory requests which includes regulatory letters, letters of authorization, technical packages, etc.
  • Provide assistance with responding to Regulatory agency request for information, regulatory inquiries or in support of customer regulatory filings.
  • Support project development teams and communicate regulatory progress, decisions, strategies, etc to cross functional teams with guidance.
  • Develop specific objectives and manage work assignments, with minimal guidance, in an effort to achieve personal objectives in conformance with overall business goals.
  • Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
  • Challenge processes, remain open to ideas and changes to continuously improve and seek better alternatives and drive change.
  • Adhere to all applicable government and company regulations, practices and procedures to maintain compliance.
  • Clearly and effectively communicate team/project progress/status, decisions, timelines, etc.
  • Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, eCTD and others as required.
 
qualifications:
  • Bachelor's or Master's degree in related discipline.
  • Bachelor's degree with 2-4 years or Master's degree with 1-3 years regulatory/pharmaceutical experience.
  • Knowledge of elastomer product portfolio
  • Experience in regulatory CMC with technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
  • Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
  • Excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts.
 
skills: Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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