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Senior Regulatory Affairs Project Manager

2 months ago

Exton, Pennsylvania, United States West Pharmaceutical Services Full time

Job Overview

The Senior Regulatory Affairs Project Manager is accountable for overseeing regulatory projects related to West's extensive range of medical devices, combination products, software as a medical device (SaMD), and packaging solutions. This role requires collaboration with diverse teams and leadership of the regulatory group throughout all stages of project execution to facilitate submissions such as Premarket Notifications, Technical Documentation in compliance with EU MDR (Medical Device Regulation), and Master Files (DMF/MAF) linked to pharmaceutical partners' NDAs (New Drug Applications), ANDAs (Abbreviated New Drug Applications), and/or BLAs (Biologics License Applications). The individual must stay informed about current international regulations, guidelines, and policies pertinent to West's offerings. This position also entails providing regulatory advice and updates to both internal and external stakeholders according to established regulatory strategies.

Key Responsibilities:

  • Serve as the lead for regulatory projects across various phases (Pre-Submission, Submission, Post-Submission, and Post-Approval), ensuring timely achievement of project goals aligned with the regulatory affairs team's priorities.
  • Oversee the development, review, and submission of intricate global regulatory documents, responses to information requests, change notifications, and compliance reports.
  • Conduct independent analysis and monitor regulatory project progress against set milestones, create integrated timelines, and proactively identify and escalate project risks or technical gaps to leadership.
  • Engage in regulatory planning and assist in formulating global regulatory strategies, considering the latest guidance documents and contemporary standards/regulations.
  • Collaborate with regulatory leads, project managers, and subject matter experts in R&D, quality assurance, clinical affairs, labeling, and more to synchronize deliverables for global submissions, establish key regulatory positions, and ensure compliance in product development and lifecycle management activities.
  • Develop and implement action plans for addressing regulatory risks and resolving 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 guide regulatory actions.
  • Assist in establishing and maintaining tools, procedures, and systems for the Regulatory Project Management team.

Basic 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.
  • Demonstrated technical leadership capabilities and understanding of pharmaceutical and/or medical device operations.
  • Proficient in project management software and regulatory tools.
  • A successful track record of regulatory submissions and interactions with regulatory bodies.
  • Experience in the development and registration of regulated combination products and medical devices, with a thorough understanding of industry-specific regulations and standards.
  • Exceptional project management abilities, including planning, execution, and budget oversight.
  • Fundamental knowledge of Quality Management System (QMS) requirements and relevant regulatory standards.
  • Experience in medical device lifecycle management, including change controls and post-market surveillance.
  • Regulatory Affairs Certification (R.A.C) and/or Project Management Professional (PMP) Certification is advantageous.

Travel Requirements:

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

Physical and Mental Requirements:

  • Ability to work independently in a fast-paced environment while adhering to multiple time-sensitive commitments.
  • Sedentary role requiring occasional exertion of up to 10lbs/4kgs.
  • Capability to comprehend principles of math, science, engineering, and medical device usage.
  • Ability to handle technical documentation with a high degree of confidentiality.
  • Proficient in researching, reading, analyzing, and interpreting complex regulatory literature and documentation.
  • Skill in organizing complex information and deriving general conclusions.
  • Ability to utilize judgment and make decisions considering relative risks and benefits.
  • Competence in assessing, planning, scheduling, and managing multiple projects and priorities concurrently.
  • Effective team member with the ability to collaborate well in cross-functional teams.
  • Proficient in applying language skills necessary for job performance.
  • Ability to document data and information as required by procedures.

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