Submission Specialist, Regulatory Operations

US or UK, Virtual


Submission Specialist, Regulatory Operations – 100% virtual role

(Associate – Senior, title commensurate with experience)

The Regulatory Operations Submission Specialist provides expert document support to all of Boyds’ team functions across a dynamic range of client projects. Performs as a document compliance expert and a publishing and submission specialist for submissions to the FDA, EMA, MHRA, and others for varied and multifactorial regulatory submissions.

The successful incumbent will embody Boyds five core values: Supportive, Strategic thinkers and problem solvers, Respected, Pioneering, and Inspiring

Qualifications:

  • BS in life sciences, computer sciences or other technical degree preferred.
  • Strong experience and current knowledge of document formatting and submissions regulations and guidances; international experience preferred. This includes eCTD modules and other global formats.
  • Successful history of US, EU, UK submissions (INDs, BLA/NDA, CTAs, MAAs).
  • Minimum 2 years of experience in regulatory publishing with a broad range of submission content, especially early-stage projects: pre-clinical, clinical, through phase 3 and beyond.
  • Effective communicator versed in interactions with cross-functional teams.
  • Independent contributor able to thrive in a virtual environment with a global team and client base. Support and training will be provided for the role.

 

Responsibilities:

  • Lead or assist in regulatory document formatting ensuring compliance to all regulatory requirements. This includes confirmation of standard formatting requirements (font, margins, table of contents, hyperlinks, etc.) Formatting will be directed by health authority requirements as well as Boyds in-house templates and style guide or other based on client request.
  • Lead or assist in submission publishing in designated software system to the appropriate electronic submission pathways. This includes document upload, cross-document and cross-submission hyperlinking, validation, QC process, issue resolution, and final submission with certificate archiving as necessary.
  • Liaise with the regulatory project lead and/or client throughout the submission to communicate timelines, issue resolution and scheduling.
  • Contribute to the implementation and maintenance of Regulatory Operations documents such as SOPs, work instructions and related continuous process improvements.
  • Act as a backup for the other regulatory operations employees.
  • Assist in internal quality control activities as required including working along with the Boyds quality unit to ensure ongoing compliance.
  • Commonly acts as subject matter expert.
  • Input and support for team development, growth, and structure, including Boyds’ approach to quality management and project oversight as it pertains to regulatory operations.
  • Resolve internal/external project issues as needed, with escalation to senior management when appropriate.

 

Technical Support:

  • Excellent verbal and written communication with the capability to successfully navigate complex and discrete client communications.
  • Skilled in electronic submissions software such as DocuBridge, eCTD Manager, RIM Smart and/or other submission platforms as well as submissions tools in Adobe etc.
  • Must be skilled in MS Office (Word, Excel, PowerPoint), and an effective and open remote communicator.
  • Utilization of virtual platforms such as Teams, Zoom and others is required.
  • Meticulous records keeping and organizational skills across the Boyds and client applications.

 

Departmental General Responsibilities: 

  • Ability to work on multiple projects, while maintaining quality and timelines, and able to prioritize workload with minimal supervision.
  • Provide support to all ongoing projects and business activities as required.
  • Opportunities for domestic and international conferences, exhibitions, and seminars as applicable.
  • Maintain modern regulatory knowledge and contribute to the company’s regulatory intelligence function. Participate in cross-functional learning and training.

The responsibilities outlined in this job description are illustrative of the typical requirements of this role.  The functions may be expanded and/or specified based on Boyds and clients’ needs. The incumbent is expected to contribute to Boyds overall and is expected to become involved in a scope of work within the range of their skills and capabilities to allow the organisation to respond effectively to its business needs.

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If you are interested in joining us, please email with your CV attached recruitment@boydconsultants.com to apply.

No agencies, please.