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Sr. Specialist, Regulatory Affairs, Product Stewardship
Sr. Specialist, Regulatory Affairs, Product StewardshipWest Pharmaceutical Services • Exton, PA, US
Sr. Specialist, Regulatory Affairs, Product Stewardship

Sr. Specialist, Regulatory Affairs, Product Stewardship

West Pharmaceutical Services • Exton, PA, US
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Sr. Specialist, Regulatory Affairs, Product Stewardship

This role is a remote role however candidates applying must be located within a 50 mile radius to any West location.

Who We Are :

At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

The Sr. Specialist, Regulatory Affairs evaluates supplier regulatory declarations for compliance, authors and maintains material compliance certifications, and responds to internal and external customer and / or agency regulatory requests. With minimal support, the Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables and ensures compliance with West and government requirements. This position includes leading the direct communication with suppliers and escalation to Category Managers. This role requires understanding and evaluation of impact of US and international regulations / guidelines / policies applicable to all West's products (elastomers, devices, contract manufacturing, integrated systems) and services.

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, EU Medical Device Regulation) for all West global product portfolios
  • With minimal support, develop compliance process including establishment of user requirements for tools supporting compliance process where applicable
  • Lead, monitor and document communication with West's suppliers requesting supplier documentation and / or questionnaires to support compliance with applicable regulations and customer inquiries
  • Assist in development of digitalization and automation processes to improve efficiency in supplier compliance
  • Monitor regulations, legislations and policies and provide regulatory guidance and communicate regulatory progress, decisions, strategies to cross functional teams
  • Partner cross functionally within the organization (e.g. Procurement, D&T, Supplier QA) to drive efficiency, conformance and compliance
  • Provide customers with West product compliance information and data as required for regulatory compliance and submissions to North America, Europe, and Rest of World agencies
  • 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
  • Clearly and effectively communicate team / project progress / status, decisions, timelines, etc. to team and Regulatory Affairs management
  • Other duties as assigned

Education

  • Bachelor's Degree in science, math, engineering, or related discipline required
  • Master's Degree in science, math, engineering, or related discipline preferred
  • PhD in science, math, engineering, or related discipline preferred
  • Advanced degree preferred

    • Work Experience

  • Minimum 5 years Bachelor's with 5+ years required; or
  • Master's degree / PhD 2+ years medical device regulatory experience required

    • Preferred Knowledge, Skills and Abilities

  • Experience interacting with government agencies
  • Knowledge of global material compliance regulations
  • Able to comply with the company's safety policy at all times
  • Able to comply with the company's quality policy at all times
  • Able to work collaboratively across all levels of the organization to influence and persuade others
  • Excellent written and verbal communication, timeline management and leadership skills
  • Self-motivated with a proactive attitude and the ability to work effectively
  • Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures

    • License and Certifications

  • Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

    • Travel Requirements

    5% : Up to 13 business days per year

    Physical Requirements

    Sedentary-Exerting up to 10lbs / 4kgs of force occasionally, and / or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

    Additional Requirements

  • Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical / medical terminology, 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 utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one
  • Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and / or priorities in a concurrent fashion with several parallel deliverables 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 build strong relationships both internally and externally
  • Ability to work in a fast-paced environment
  • Ability to verbally communicate ideas and issues effectively to other team members and management
  • Ability to write and record data and information as required by procedures
  • Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite : Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company)

    • West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and / or drug screening.

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    Regulatory Specialist • Exton, PA, US