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Senior REACH Compliance Specialist

Requisition ID:  35591
Date:  Sep 16, 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 will be based out of Exton, PA, Scottsdale, AZ, US remote or in Waterford and/or Dublin, Ireland.  This role is responsible for REACH compliance for West’s products.  This position includes supporting internal and external customer regulatory requests and maintaining knowledge of current US and international regulations/guidelines/policies applicable to West’s products and services. 
 
PRIMARY DUTIES AND RESPONSIBILITIES: 

  • Lead REACH compliance and compliance to other global product and/or packaging regulatory/environmental legislation such as California Prop 65, RoHS, Conflict Minerals, MDR for West’s products.
  • Lead development of compliance process including establishment of user requirements for tools supporting compliance process.
  • Partner cross functionally within the organization to drive conformance and compliance.
  • Monitor new and emerging legislation/policies, determine impact and assure compliance to West’s products.
  • Provide regulatory guidance and communicate regulatory progress, decisions, strategies, to cross functional teams.
  • Provide customers with West product compliance information and data as required for regulatory submissions to European and Rest of World agencies.
  • Create documentation in response to customer regulatory requests which includes certifications, regulatory letters, technical packages, etc.
  • Maintain working knowledge of US and European pharmaceutical and medical device legislation as related to West’s products and business.
  • Adhere to all applicable government and West regulations, practices and procedures to maintain compliance. 


REQUIRED QUALIFICATIONS:

  • Education:  Bachelor, Master’s degree, or PhD in related discipline
  • Experience: Bachelors with 3-5 years; or Master’s degree/PhD with 1-3 years compliance/regulatory/pharmaceutical experience.
  • Experience in REACH Compliance with technical leadership skills, as well as demonstrated understanding of related operations (e.g., manufacturing, process development, analytical, quality assurance).  
  • 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. 

 
PREFERRED QUALIFICATIONS:

  • 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% (meetings, trainings, projects)

 

 

 

 

 

 

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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