Associate Director, Regulatory Operations and Compliance

Location
Foster City, California
Posted
Sep 25, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Job Description Summary

A hands-on role providing both strategic and operational activities.
Develops and applies a comprehensive understanding of global RA regulations and guidelines on eCTD to projects to enhance probability of regulatory success and regulatory compliance.  Establishes the RIM operations model. Plans/manages/executes all regulatory submission planning, preparation, publishing, QC, validation and timely submission of all eCTD applications and updates to global health authorities.
 
Develops and applies all necessary regulatory guidelines. Ensure document readiness and archiving of all submissions. Establishes the RIM operations model. Plans/manages/executes all regulatory submission planning, preparation, publishing, QC, validation and timely submission of all eCTD applications and updates to global health authorities.  Ensure document readiness and archiving of all submissions.
Key Duties and Responsibilities
    • Establish and drive efficient, standardized best practices for regulatory submission and quality document management, manage and prioritize publishing and administrative activities and define publishing strategies that will enable high quality submissions, delivered according to regulatory submission plan and global regulatory requirements.
    • Engage with the Head of Regulatory and Peers to define strategy and optimal interactions between the functional groups. Contribute to the evaluation, development and implementation of systems and efficient, harmonized processes to support regulatory activities including content planning, publishing, planning and tracking, document management and administration and archiving.
    • Responsible for all aspects of publishing submissions and/or submission components, and for submission to regulatory authorities. This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, production (paper and electronic), and archiving (paper and electronic), as applicable.
    • Interface with authoring disciplines and stakeholders to ensure the creation of global submission ready documents and effective management of those documents in the EDMS.
    • Manage projects with vendors and contractors to meet schedules and ensure quality.
    • Responsible for all aspects of submission readiness, including meeting internal and regulatory standards for electronic submissions, document QC and that proper processing in document management system.
    • Develop and implement standards for dossier management, publishing, archiving, metrics and submission process for global health authorities.
    • Collaborate with IT Business Partners to develop and provide training on RIM systems, tools and processes.
    • Lead or assist with other projects and activities as assigned by management, in support of the Regulatory or Quality Assurance functions, including authoring and review of SOPs.
    • Establish external relationships with industry groups related to Regulatory Operations functions. Provide accurate regulatory operations guidance and information to project and submission teams.
    • Provide advice on regulatory acceptability of submission plans.


Education and Experience
    • Bachelor’s Degree.
    • 8 years of pharmaceutical industry experience. 2-3 years in Vaccines industry preferred.
    • Experience working within Regulatory Operations environment. Preferred experience in publishing and submission management.
    • Evidence of working with US and/or EU Regulatory Agencies supporting Regulatory Dossier review and approval processes.
    • Excellent skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
    • Accustomed to fast-paced, highly-regulated environment with the ability to work independently with minimal supervision.
    • Technologically savvy with the ability to quickly learn software applications and troubleshoot as needed.
    • Proficient MS Office (Word, Excel, Outlook, PowerPoint). Proficiency in Adobe Acrobat and ISIToolBox (now TRS ToolBox) highly preferred.
    • Excellent organization skills and sound attention to detail.
    • Must work well with others.