• West Pharmaceutical Services
  • $113,830.00 -153,620.00/year*
  • Exton , PA
  • Scientific Research
  • Full-Time
  • 149 Valleyview Dr


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Specialist, Regulatory Affairs

Exton

Pennsylvania

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2017 sales of $1.6 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.

POSITION SUMMARY:

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

PRIMARY DUTIES AND 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, 510ks), 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 West regulations, practices and procudres 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.
REQUIRED QUALIFICATIONS:
  • Education: Bachelor's or Master's degree in related discipline.
  • Experience: Bachelor's degree with 2-4 years or Master's degree with 1-3 years regulatory/pharmaceutical experience.
PREFERRED QUALIFICATIONS:
  • Knowledge of West 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.
PHYSICAL & TRAVEL REQUIREMENTS:
  • 5-10% (Projects, Meetings, Training)
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a disability or special need that requires accommodation, please send an email to ...@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.
Associated topics: aseptic technique, biopharma, immunoassay, nutrition, pharmaceutical, pharmacometrics, pharmacy, physiology, therapeutic, transfection

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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