Senior Manager, Regulatory Operations
|Job Title:||Senior Manager, Regulatory Operations|
|Location:||San Francisco, California|
|Contact Name:||Ben Richardson|
|Job Published:||April 07, 2017 02:25|
Manager/Sr. Manager, Regulatory Operations
Manager/Sr. Manager, Regulatory is responsible for managing the logistics, preparation, quality assurance, and delivery of regulatory submissions in accordance with Regulatory agency requirements, company standards, and timelines. The Manager/Sr. Manager will also be responsible for participating and/or leading Regulatory Affairs systems implementation projects, including Electronic Document Management System (eDMS), publishing systems/tools and Regulatory Information Management System (RIMS).
Key Accountabilities/Core Job Responsibilities:
* Lead and/or participate in the implementation, migration, and upgrade of regulatory systems and tools (eDMS, Regulatory Information System, CTD templates, etc.).
* Perform document management tasks including file transfer, storage, tracking, and archival of Regulatory submission documentation
* Collaborate with Regulatory Affairs and contributing functional areas to create submission project plans as well as identify and allocate internal and external resources (including vendors/CROs)
* Develop and administer in-house training, according to Regulatory and submission project team needs. Training includes authoring templates, processes and tools critical to compiling all submission types
* Participate in the writing and reviewing of Regulatory processes (SOP, Work Instructions and internal guidelines)
* Apply company style guide formatting requirements to create submission ready documents that are compliant with internal and heath agency requirements
* Provides regulatory operations guidance and information to Regulatory Affairs department and submission project teams.
* Assists in the mentoring and training of Regulatory and cross-functional team members; Prepares and maintains training materials
* Leads and/or assists with other projects and activities as assigned by management to support the Regulatory Operations function, including submission compilation and publishing support.
* Knowledgeable in CTD/eCTD structure and requirements and firm understanding of submission requirements for US submission types (e.g. IND, PAS, NDA, PSUR, etc.)
* Experience in publishing and compilation of eCTD submissions and experience publishing ex-US electronic submission is desirable
* Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools
* Demonstrated organizational skills, strong verbal and written communication skills, and attention to detail including proofreading
* Maintain familiarity with current regulatory submission standards and industry best practices. Use knowledge gained from industry teams and working groups to contribute to departmental best practices
* Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities
* Demonstrated verbal and written communication skills.
* Demonstrated project management experience to include excellent organizational, prioritization and planning skills.
* Ability to multi-task, pay close attention to detail, and follow projects through to completion.
* Minimum 5 years related experience in publishing and Regulatory Systems role within the biotechnology or pharmaceutical industry
* Experience in implementing Regulatory systems, preferred
Education Requirements (degree, certifications, etc.):
* Bachelor's degree preferred; Equivalent experience within the Regualtory Operations function will be considered
If this is a role that you would like to learn more about, please apply ASAP!
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