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West Pharmaceutical Services · 1 day ago

Sr. Specialist, Regulatory Affairs, Product Stewardship

Exton, PA

Full-time

Hybrid

Senior Level

5+ years exp

West Pharmaceutical Services is a dedicated team focused on improving patient lives through innovative healthcare solutions. The Sr. Specialist in Regulatory Affairs will evaluate supplier regulatory declarations for compliance, maintain material compliance certifications, and lead communication with suppliers to ensure adherence to regulatory requirements.

BiotechnologyHealth CareIndustrialManufacturingPackaging ServicesPharmaceutical

No H1B

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

Qualification

Regulatory AffairsMaterial ComplianceMedical Device RegulationsRegulatory Affairs CertificationCross-functional CollaborationProactive AttitudeMicrosoft Office SuiteCommunicationProject Management

Required

Bachelor's Degree in science, math, engineering, or related discipline required

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

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)

Preferred

Master's Degree in science, math, engineering, or related discipline preferred

PhD in science, math, engineering, or related discipline preferred

Advanced degree preferred

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

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