AbbVie Pharmacyclics Sr. Manager, Regulatory Operations in Sunnyvale, California

Sr. Manager, Regulatory Operations

Location: Sunnyvale, CA

# of Openings: 1

Description

Sr. Manager, Regulatory Operations 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 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, reviewing and approving 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 large and/or complex submission project as well as other projects as assigned by management to support the Regulatory Operations function, including leading efforts associated with submission management and submission compilation.

Qualifications:

  • 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.

Experience:

  • Minimum 5 years related experience in publishing and/orRegulatory Systems role within the biotechnology or pharmaceutical industry

  • Minimum 2 years direct people management/supervisory experience required

  • Experience in implementing Regulatory systems preferred

  • Experience in managing a department budget preferred

Education Requirements (degree, certifications, etc.):

  • Bachelor’s degree preferred; Equivalent experience within the Regulatory Operations function will be considered

Equal Opportunity Employer Minorities/Women/Veterans/Disabled