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Manager, Regulatory Operations and Submissions

MMS is a global CRO, that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. We are a pharmaceutical service provider supporting pharmaceutical and biotech industries with medical writing, biostatistics, clinical programming, data management, clinical development, regulatory affairs, regulatory submissions and pharmacovigilance.

Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patients' lives worldwide.

Job Description

  • Provides oversight for the team(s) responsible for global submissions including the compilation, preparation, review and submission to Health Authorities
  • Assists in strategic planning activities and translation of strategic decisions into operational plans related to all areas of regulatory operations
  • Provides oversight to ensure processes are in place for the publishing of regulatory submissions according to ICH electronic Common Technical Document (eCTD) format and submission ready standards
  • Ensures submission project plans are created and maintained
  • Ensures team deliverables align with applicable regional, ICH, company and client defined standards
  • Ensures processes are in place to support high quality and complete project deliverables that are released to client
  • Maintains technical expertise of regulatory requirements and ensures alignment with company processes and client requirements
  • Identifies resources and technologies as needed to support submission activities and to resolve identified issues and risks
  • Identifies resources and provides guidance for process updates due to changing regulations that impact submission strategies and technologies
  • Acts as a resource to project teams to provide guidance in producing high-quality client deliverables
  • Demonstrates excellent internal and external leadership skills
  • Practices excellent internal and external customer service
  • Produces and presents external company presentations providing industry visibility for the organization
  • Directs, manages and oversees the daily activities of personnel; supervises other colleagues
  • Serves as MMS point of contact with clients for regulatory issues as needed.
  • Contributes to defining project scope, timelines and potential resources needed to meet client requested services
  • Identifies risks and opportunities and addresses as needed with a focus on customer satisfaction

Requirements

  • Graduate degree preferred in related discipline/ industry
  • 10+ years of experience in pharmaceutical or CRO industry required
  • Experience leading pre- and post-approval marketing applications (both NDA and MAA)
  • Strong knowledge of current and upcoming Health Authority regulations, particularly related to data standards and exchange
  • Working knowledge of ex-US submissions (CTA and MAA), including EMA, Health Canada, and Australia
  • Proven track record for strategic design and implementation of new services, especially within a changing regulatory environment
  • Experience with data and document transparency initiatives
  • Work in conjunction with project management and business operations to build opportunities, enhance collaboration, and increase networking with existing and potential new clients
  • Manage cross-functional teams and progress partnerships in support of goals that affect colleagues in all regions
  • Demonstrated managerial skill and experience of onsite and remote colleagues, including Asia operations
  • In-depth understanding of regulatory submissions processes, clinical development and operations implementation and management, the drug development process and regulatory guidelines
  • Proficiency with MS Office and SharePoint applications
  • Self-motivated with excellent skills in multi-tasking,  attention to detail and follow-through
  • Excellent organizational, project coordination and communication skills
  • Familiarity with ISO 9001 requirements
  • Ability to anticipate and effectively resolve potential issues and client requests
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