Sr. Manager, Regulatory Operations

Location: Emeryville, CA
Department: Regulatory

Position Summary:

The Senior Manager of Regulatory Operations will oversee all aspects of publishing efforts of multiple programs and manage outsourced regulatory publishing activities in preparation of high-quality submission packages and their timely delivery to global regulatory authorities. This position will also be contributing to the evaluation and implementation efforts for publishing software in support of preparing compliant electronic submissions to Regulatory Agencies in-house. This position will report to and work closely with the Regulatory Senior Director and participate in the development of Regulatory Operations processes (SOPs, work instructions, guidelines, templates) for preparing submissions and regulatory information management.

Responsibilities

  • Partner with Regulatory Affairs, Program Management, Product Development, Medical Writing to provide operational oversight and support for the planning, preparation, tracking, and timely submission of all eCTD and non-eCTD Submissions to global health authorities (e.g. IND, NDA, BLA, MAA, etc.).
  • Manage all technical aspects for submissions such as advising authors of required eCTD document granularity, utilization of content templates, style guide, document formatting, eCTD application location, publishing, QC, validation, and transmission to regulatory health authorities.
  • Manage effective and up-to-date Regulatory Information Management and Archiving systems; maintain initial applications and amendments across global development programs
  • Identify, analyze, and implement applicable industry technologies in accordance with applicable regulations, for sustainability and scalability of the organization and propose changes accordingly. Identify issues that will impact programs and provide proactive strategies for dealing with them. 
  • Maintain knowledge of current global regulatory requirements for submission formats.
  • Work with Regulatory Affairs and contributing functional areas in establishing submission plans. Oversee and/or prepare Regulatory submissions globally using internal and external resources.
  • Participate in the interpretation and implementation of new health agency guidelines and rules relevant to regulatory submissions.
  • As a global submissions expert, ensure the project team has awareness and knowledge of e‑submissions (eCTD, NeeS, etc.) and life cycle management concepts; communicate regional differences as appropriate within the context of global submission preparation.

Core Competencies, Knowledge and Skill Requirements

  • Must have a strong attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.
  • Must be able to assist management in prioritizing and balancing multiple tasks to accomplish department goals.
  • Work under minimal supervision and independently determine and develop solutions to moderately complex problems.
  • Must possess flexibility to work effectively within an environment that has quickly changing processes, priorities and deadlines.
  • Must have strong problem-solving skills on moderately complex problems in relation to streamlining department processes and technology used in relation to submissions.
  • This position requires the ability to master new technical skills and apply them to projects as the industry and the company evolves.
  • Shows strong initiative and drive. Must be an organized self-starter who is able to anticipate departmental needs.
  • Excellent organizational, communication, attention to detail, and time management skills.
  • Excellent interpersonal skills and ability to work successfully within a cross-functional team.

Requirements

  • BS or BA in science / technology or an equivalent combination of education and experience preferred.
  • 8+ years of experience in a Regulatory Operations role within the pharmaceutical or biotech industry.
  • Current and strong working knowledge of electronic document and submission standards and requirements (CTD/eCTD structure) applicable to the US, EU and global regulatory environments.
  • Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools
  • Knowledge of IT systems and electronic submission requirements and processes
  • Strong knowledge of and experience with MS Word, Acrobat Professional and Advanced PDF Processing Tools (ISIToolBox).
  • Knowledge of CDISC (ADaM, SEND, SDTM).
  • Excellent understanding of structure of reports and submission documents.
  • Experienced in managing web-based content and document management environments (e.g. SharePoint, Veeva, EDMS solutions).

 

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