Director Combination Products Regulatory Affairs

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Yoh - A Day & Zimmerman Company
Director, FDA, QA, Sales
Full Time

Job Description

Full Time Direct Hire

POSITION SUMMARY: This position can be based out of Exton, PA or Scottsdale, AZ. The Director of Regulatory Affairs is responsible for developing and implementing Chemistry, Manufacturing, Control (CMC) regulatory strategies which lead to and maintain regulatory approvals and compliance for combination products utilizing West's innovative medical device in accordance with global regulations and guidelines. Specific responsibilities include providing CMC regulatory guidance for clinical phases through commercialization of combination products, support regulatory submissions, agency interactions and provide study oversite for Human Factor for product development and labeling. This role provides leadership and partners closely with internal and external marketing, R&D, quality, regulatory and engineering and manufacturing, functions.

  • Serve as the global leader for the development, communication, lifecycle management of CMC regulatory strategy for complex projects in coordination with our partners large and/or small molecule combination products.
  • Manage execution of CMC documentation supporting IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports and responses to health authority questions per established business practices.
  • Manage a regulatory team responsible for human factors study design, execution and reporting for medical device and combination products, including planning and managing HF team and studies (formative, validation), and related documentation according to FDA guidelines and applicable global standards
  • Work closely with cross-functional management involved with R&D, QA, Operations, HR, Legal, Marketing, and Sales to develop and implement regulatory strategies which position West products for use in pharmaceutical applications.
  • Directly engage global regulatory bodies, Notified Bodies, etc., to resolve issues, provide guidance, and influence agency thinking on global industry best practices affecting West products and business objectives.
  • In partnership with Regulatory management the Director of Regulatory Affairs must ensure compliance with global regulations for design controls, cGMP, facility registration, device listing, licenses, safety reporting, complaints, clinical trial requirements, post-market surveillance, labeling, and permissible marketing communication.
  • Provide regulatory expertise and operational direction to management, internal, and external customers to ensure conformance and compliance with corporate requirements, government regulations, guidelines and industry standards.
  • Review changes in international laws and regulations and assess their impact and make recommendations to ensure compliance of West's products.
  • Work closely with RA management to successfully achieve cross functional departmental and enterprise objectives.
  • Provide regulatory representation on project steering teams, as necessary.
  • Review technical project documentation, certifications, correspondences, and external communications, as needed, providing guidance and direction where applicable.
  • Independently develop and perform specific objectives and manage highly complex work assignments to achieve personal objectives in conformance with overall business goals.
  • Participate on and/or lead project teams for assigned projects and communicate updates regarding regulatory guidance, directives, policies, etc. in support of ongoing project/product activities.
  • Proactively identify and champion process improvements within RA and larger West teams.
  • Provide support in the development of business proposals/contracts/objectives.
  • Train, mentor and guide activities of direct reports, RA staff members and peers to define and achieve personal, departmental and corporate objectives.
  • Responsible for leading a team of regulatory and human factor professionals.

  • Education: Bachelor's, Master's or PhD in science related discipline
  • Experience: Bachelor's with 10+ years; or Master's degree with 8-10 years or PhD with 7-8 years CMC regulatory affairs/pharmaceutical experience in the area of combination product development and registration.

  • Experience in leading Health Authority meetings (local and international agencies) is highly preferred.
  • Experience in CMC regulatory with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
  • Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
  • Excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts.
  • Capability to work effectively in matrix organizational structures.
  • Demonstrated ability to collaborate and communicate across cultures, organizational levels and disciplines.
  • Experience in Regulatory Affairs project management and effective team leadership.
  • Practical experience in the development of human factor study design



Company Information

Are you a .NET mastermind, world class DBA, Java guru or SAP pro? Perfect, because Yoh wants to match your career aspirations with the job demands of today.
Dice Id : 10107614
Position Id : 295460
Originally Posted : 1 month ago

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