Regulatory Submissions Manager

The Regulatory Submissions Managerworks with global publishing teams to deliver on commitments to Virtify’s clients. The Regulatory Submissions Manager performs submission publishing activities in accordance with relevant regional agency guidelines and Virtify’s SOPs and Work Instructions. Quality and timeliness of customer deliverables is the main objective.

Duties and Responsibilities:

  • Interact with clients regarding regulatory issues and deliverables on electronic submissions projects (eCTD, SPL etc.)
  • Manage global teams to ensure quality and timeliness of customer deliverables
  • Conduct regulatory reviews of technical summaries, clinical study reports, and administrative documents for regulatory filings
  • Assure submissions adhere to ICH guidelines and working knowledge of key health authorities
  • Conduct regulatory reviews for eCTD/electronic submission requirements
  • Work with global publishing teams to provide the following activities:
    • publishing readiness
    • submission readiness
    • electronic publishing
    • paper publishing
  • Maintain familiarity with current global regulatory submission standards
  • Maintain familiarity with departmental standard operating procedures and work instructions
  • Assist with the development and implementation of systems and procedures used to support regulatory submission activities (eCTD production, document publishing, and document management)
  • Evaluate current processes and systems with regard to industry best practices
  • Propose changes targeting greater efficiency and continued compliance
  • Develop proposals for system and process development to support greater efficiency and continued regulatory compliance
  • Support compliance with worldwide submission regulations and guidelines
  • Other duties, as assigned.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • 8 years of pharmaceutical industry experience
  • 5 years of experience compiling electronic submissions
  • Experience compiling IND, NDA/BLA, and CTD submissions
  • Understanding of eCTD submission requirements
  • Must have a good understanding of submission compilation and application requirements, applicable regulations, and eCTD/electronic submission requirements with advanced skills with submission publishing software
  • Bachelor's degree or equivalent experience
  • Good verbal and written communication skills
  • Highly self-motivated and independent
  • Extensive experience in examining, investigating and solving dynamic problems with ability to think "out-of-the-box” and develop creative solutions
  • Well-organized with the ability to multi-task and work with minimal supervision
  • Must have the ability to manage multiple projects simultaneously
  • Must have prior experience in communicating with internal Customers and exposure to communicating and interacting with external Customers
  • Proficient in Microsoft Windows environment including, but not limited to, Microsoft Office products; Adobe Acrobat and plug-ins; electronic document management systems; experience of publishing systems.
  • Office based role in Cambridge, MA
  • Less than 25% business-related travel.
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