Latham BioPharm Group

Latham BioPharm Group (LBG) unites teams and technologies in the Life Sciences. We provide high level product development and program management, technical, business development, and strategic consulting services and have proven expertise in biodefense and pandemic response, and strategic product development for biopharmaceuticals, vaccines, cell and gene therapies and bioprocessing technologies. We provide these services to life science companies looking to secure, or who have secured, funding in both the federal and commercial sectors. LBG is expanding its regulatory operations capabilities to include the preparation and publishing of regulatory documents for both US FDA eCTD submissions and international regulatory submissions.

Title: Regulatory Operations – Analyst through Senior Associate

Position Reference: 2020010

Primary Location: Remote, Cambridge, MA or MD

Travel: Estimated to be up to 20%, upon re-start of business travel. Actual travel requirements are variable dependent on primary location, conferences and business opportunities and client requirements, and not a predetermined number of days per week or month.

Key Role:

LBG is seeking an experienced professional with demonstrated expertise with the finalization and publishing of regulatory documents for eCTD submission. S/he will play a key role in representing LBGs product development team by leading the finalization and publishing of regulatory documents for electronic submission. Duties will include organizing internal publishing activities, and provide document format training and preform formatting and publishing for all regulatory documents. S/he will play a key role in supporting the Regulatory Submissions service offering in publishing pivotal documentation, and its timely delivery.

In the role of Senior Associate, this individual will provide programmatic and technical regulatory operations support for multiple cross-functional teams spanning different product development programs (small molecule, large molecule, vaccine and gene therapies, medical devices and diagnostics) with both commercial clients and in support of government-product development contracts. This individual will engage with LBG clients (existing and prospective), US Government agencies, teaming partners and other internal LBG stakeholders; and must have strong interpersonal and leadership skills.

Job Duties:

• Work closely with other LBG stakeholders and the client to provide programmatic support to manage successful execution of client deliverables
• Serve as formatting and publishing lead on cross-functional programs (INDs, NDAs, BLAs)
• Be responsible for the creation of document tracking (content plan)for all regulatory submissions
• Format documents supplied by contributors are in compliance with applicable regulatory agencies using Microsoft Word and PDF tools
• Be responsible for ensuring that the final exported sequence for submissions contains documents as required for the submission
• Be responsible for communicating any potential concerns regarding timelines to the project team.
• Create, assemble, and publish major and routine electronic submissions in eCTD format per regulatory and client requirements, including NDAs/BLAs, INDs, annual reports, supplements, amendments, etc.
• Serve as the coordinator for internal publishing activities, interacting with project teams to assist with timelines and deliverables related to submission documents and projects.
• Maintain an in-depth knowledge of regulations governing the content and formatting of submission documents, as required by the FDA, ICH, and other regulatory bodies.
• Serve as the internal subject matter expert for training and support on formatting and publishing processes and software.
• Deliver on assigned programs and meet target billing requirements.
• Engage with prospective and current clients and ensure satisfaction with regard to LBG performance.
• Adhere to LBG standards of high quality client deliverables and core values.
• Support the Growth of the Company and its Capabilities as required:
  • Assist in the identification of and participation in new engagement opportunities.
  • Support LBG proposal development activities and winning new business as required.
  • Support the management of existing and potential client relationships.
  • Support the creation of internal tools, systems, methods and materials that help the Company perform more efficiently and with higher quality results.
  • Support the creation and delivery of publications, white papers and presentations that support and build on the Company’s reputation and recognition in its target markets.