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Title:  Sr. Specialist, Regulatory Affairs, Product Stewardship (Remote)

Requisition ID:  48943
Date:  Jun 18, 2022
Location: 

Exton, Pennsylvania, US

Department:  Regulatory Affairs
Description: 

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.

 

Job Summary:

This role is responsible for coordinating, authoring, and managing material compliance certifications for West’s elastomeric and device product portfolios.  With minimal support, the Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables and ensures compliance with West and government requirements.  The Sr. Specialist supports raw material change controls, internal and external customer regulatory requests, R&D product development while maintaining knowledge of current US and international regulations/guidelines/policies applicable to West’s products and services. This position can accommodate a remote work location.

 

Essential Duties and Responsibilities:

  • Drive material compliance to applicable global product and/or packaging regulatory/environmental legislations (e.g. California Prop 65, RoHS, Conflict Minerals, Medical Device Regulation) for West’s elastomer and device product portfolios
  • With minimal support, develop compliance process including establishment of user requirements for tools supporting compliance process where applicable
  • Manage change controls and determine impact to Compliance Bulletins
  • 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 North America, European and Rest of World agencies
  • Create documentation in response to customer regulatory requests which includes certifications, regulatory letters, technical packages, etc.
  • Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management
  • Maintain working knowledge of US and European pharmaceutical and medical device legislation as related to West's products and business
  • Train, mentor and/or guide the activities of RA staff members and peers to define and achieve personal, departmental, and corporate objectives, as applicable
  • Develop specific objectives and manage work assignments in consultation with management as needed, 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, seek better alternatives, and drive change
  • Adhere to all applicable government and West regulations, practices and procedures to maintain compliance
  • 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
  • Other duties as assigned

 

Basic Qualifications: 

  • Education:  Bachelor's, Master's degree or PhD in science, math, engineering or related discipline
  • Experience: Bachelors with 3-5 years; or Master's degree/PhD with 2+ years regulatory/pharmaceutical/material compliance experience
  • Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance)
  • Attention to detail with planning, time management and organizational skills
  • Self-motivated with a proactive attitude and the ability to work effectively
  • Excellent interpersonal, communication and technical writing skills

 

Preferred Knowledge, Skills and Abilities:

  • Knowledge of West elastomer product portfolio
  • Experience interacting with government agencies

Travel Requirements:

  • Must be able to travel up to 5 – 10 % of the time (meetings, trainings, projects, industry events)

 

Physical & Mental Requirements:

Ability to comprehend principles of math, science, and engineering.  Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality. Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, technical product information, and complex documents. Ability to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions.  Ability to assess, plan, schedule and manage multiple projects, tasks, responsibilities and/or priorities and execute deliverables to time-line commitments. Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.

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 Apply.Accommodation@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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