Senior Regulatory Affairs Project Manager

1 week ago

Exton, Pennsylvania, United States West Pharmaceutical Services Full time

Job Overview

The Senior Regulatory Affairs Project Manager (RPM) position is crucial for overseeing regulatory initiatives linked to West's extensive range of medical devices, combination products, software as a medical device (SaMD), and packaging solutions. The RPM will collaborate effectively with various teams and guide the regulatory group through all stages of projects to facilitate submissions, including Premarket Notifications, Technical Documentation under EU MDR (Medical Device Regulation), and Master Files (DMF/MAF) related to pharmaceutical partners' NDAs (New Drug Applications), ANDAs (Abbreviated New Drug Applications), and/or BLAs (Biologics License Applications). Staying informed about current international regulations, guidelines, and policies relevant to West's offerings is essential. This role also involves providing regulatory insights and updates to both internal and external stakeholders according to established regulatory strategies.

Key Responsibilities:

  • Serve as the lead RPM on cross-functional regulatory projects throughout the entire lifecycle (Pre-Submission, Submission, Post-Submission, and Post-Approval) while ensuring the timely achievement of project goals aligned with the regulatory affairs team's objectives.
  • Oversee the preparation, evaluation, and submission of intricate global regulatory filings, responses to information requests, change notifications, and post-market compliance reports.
  • Independently assess and monitor regulatory project progress against set milestones, develop comprehensive timelines, and proactively identify and escalate project risks or technical deficiencies to leadership.
  • Engage in regulatory planning and contribute to the formulation of global regulatory strategies, taking into account the latest guidance documents and contemporary standards/regulations.
  • Collaborate with regulatory leads, project managers, and subject matter experts (SMEs) across R&D, quality assurance, clinical affairs, labeling, and other areas to align on deliverables for global submissions, establish key regulatory positions, and ensure compliance with applicable regulatory requirements throughout product development and lifecycle management.
  • Develop and implement action plans for regulatory risk mitigation and resolution of submission issues. Maintain logs of issues and manage risk mitigation efforts throughout the project lifecycle.
  • Create regulatory project charters and maintain dashboards that provide insightful performance metrics and critical information to stakeholders.
  • Prepare for and manage regulatory audits and inspections by authorities, ensuring timely resolution of findings or nonconformities.
  • Stay updated on evolving regulations, guidelines, and industry trends to inform regulatory actions.
  • Assist in establishing and maintaining the necessary tools, procedures, and systems for the Regulatory Project Management (RPM) team.

Required Qualifications:

  • Education: Bachelor's or Master's degree in a scientific, engineering, or related field.
  • Experience: Bachelor's degree with 5 years of experience; or Master's/PhD with 2-3 years of experience in the development, scale-up, and registration of regulated medical devices and combination products.

Preferred Skills and Attributes:

  • Strong interpersonal, communication, and organizational skills with a proven ability to work with and influence multidisciplinary teams and external industry experts.
  • Technical leadership capabilities, along with a solid understanding of pharmaceutical and/or medical device operations (e.g., manufacturing, process development, analytical, quality assurance).
  • Proficiency in project management software and regulatory tools.
  • Demonstrated success in regulatory submissions and interactions with regulatory authorities.
  • Experience in the development and registration of regulated combination products and medical devices, with in-depth knowledge of industry-specific regulations and standards.
  • Exceptional project management skills, including planning, execution, and budget oversight.
  • Fundamental understanding of Quality Management System (QMS) requirements, state-of-the-art standards (ISO 13485, ISO 14971, ISO 15223, IEC 62304, ISO 11608), 21 CFR Part 820, and CMC regulatory requirements.
  • Experience in medical device lifecycle management, including change controls, device complaint investigations, CAPAs, and post-market surveillance.
  • Regulatory Affairs Certification (R.A.C) and/or Project Management Professional (PMP) Certification.

Travel Requirements:

  • Willingness to travel up to 5% of the time.

Physical and Mental Requirements:

  • Ability to work independently in a fast-paced, dynamic environment while adhering to multiple time-sensitive commitments.
  • Sedentary work environment: may involve exerting up to 10lbs/4kgs of force occasionally, and/or negligible force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body.
  • Ability to comprehend principles of math, science, engineering, and medical device use.
  • Capacity 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, 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 synthesize it into general rules or conclusions.
  • Ability to exercise judgment and make decisions considering the relative risks and benefits of potential actions to select the most appropriate course of action.
  • Ability to assess, plan, schedule, and manage multiple long-term and short-term projects, tasks, responsibilities, and/or priorities concurrently while executing deliverables to meet timelines.
  • Ability to be an effective team member and collaborate well with others in a team environment on cross-functional and/or matrix teams.
  • Ability to comprehend and apply language skills to the degree required to perform the job based on the job requirements listed above.
  • Ability to document and record data and information as required by procedures.

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