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Associate Product Stewardship Specialist

Requisition ID:  35545
Date:  Sep 20, 2021
Location: 

Exton, Pennsylvania, US

Department:  Regulatory Affairs

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

This role is responsible for coordinating, authoring, and maintaining material compliance certifications for West’s products on our Regulatory Affairs Team.  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 structured regulatory assignments with guidance in support of R&D and commercial programs with a focus on coordinating, authoring, and maintaining material compliance certifications, customer requests, etc. in compliance with regulations, guidelines and procedures.
  • Support project development teams and communicate regulatory progress, decisions, strategies, etc., with guidance.
  • Review assigned technical project documentation, certifications, correspondences, and external communications, as needed.
  • Provide assistance with customer regulatory requests, including regulatory letters, compliance questionnaires, LOAs (Letters of Authorization/Access).
  • Develop specific objectives and manage work assignments, with 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 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.

 

REQUIRED QUALIFICATIONS: 

  • Education: Bachelor's in related discipline
  • Experience: 0-3 years of regulatory/pharmaceutical/chemical industry experience preferred

 

PREFERRED QUALIFICATIONS:

  • Knowledge of CMC regulatory affairs and regulatory operations including sterile pharmaceutical products produced by aseptic processing, direct interactions with regulatory agencies and management of regulatory support systems is a plus.
  • Demonstrated ability to manage multiple tasks/projects/priorities simultaneously is required.
  • Excellent interpersonal, communication and listening skills

 

 

 

 

 

 

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 special need that requires accommodation in order to apply to West, please send an email to kimberley.eby@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.

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