Regulatory Affairs Specialist

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

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
  • 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.
  • 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.

easy apply

get jobs in your inbox.

sign up

related jobs