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Associate Regulatory Affairs Specialist (Chinese/Mandarin -Bilingual)

Requisition ID:  35409
Date:  Jul 9, 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 position requires the applicant to be Bilingual; Fluent in English and Chinese/Mandarin (written and communication)

 

This role is responsible for translating, coordinating, and authoring, regulatory submissions and technical documentation supporting  West’s products and processes.   Maintain knowledge of current US, China, and rest of world policies/regulations/guidelines applicable to West’s products and services.

 

Essential Duties and Responsibilities:

  • Complete structured regulatory assignments with guidance in support of Research and Development (R&D) and Commercial programs with a focus on translating, maintenance and tracking of CMC dossiers for submission to Health Authorities [DMFs, MAFs, 510(k)s], customer requests, etc. in compliance with policies, regulations, guidelines and procedures.
  • Translate/review assigned technical project documentation, certifications, correspondences, and external communications, as needed.
  • Review and edit machine-translated product documentation and associated content. 
  • Support analysis of policies/regulations and impact to West’s products and processes.
  • Support analysis of data tracking/trending.
  • Become familiar with West’s elastomeric and device portfolios
  • Assist on Development Agreement programs and evaluating certifications for medical devices, as assigned. 
  • Provide assistance with Letters of Authorization (LOA) and filing forms, as needed. 
  • 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/data analysis packages including Power BI, MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint, LOA request system, eCTD and others as required.

 

Basic Qualifications: 

  • Education: Bachelor's in related discipline
  • Experience: 1-3 years of language-related experience in translating, proof-reading, editing technical documentation; preferably in regulatory /pharmaceutical or related fields
  • Bilingual; Fluent in English and Chinese/Mandarin (written and communication)

 

Preferred Knowledge, Skills and Abilities:

  • Experience with Health Authorities and/or 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.

 

Travel Requirements:

  • Must be able to travel up to 5% of the time 

 

 

 

 

 

 

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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