Specialist, Regulatory Operations
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
Responsible for the compilation of routine eCTD submissions for various submission types (e.g. safety reports, investigator information, protocol amendments, etc.) on a daily basis.
Provide publishing support for non-routine or complex submissions (e.g. NDA, CTA, IMPD)
Perform document management tasks including file transfer, storage, tracking, and archival of Regulatory submission documentation (including SPL, FDA correspondence and submissions)
Apply company style guide formatting requirements to create submission ready documents that are compliant with internal and heath agency requirements
Participate in Regulatory Affairs systems implementation projects
Participate as a team member on cross functional submission team to provide input into formatting, granularity and general submission requirements.
Perform quality reviews of published documents and submissions per internal standards.
Create and/or maintain submission authoring templates
Participate in the writing and reviewing of Regulatory processes (SOP, Work Instructions and internal guidelines)
Collaborate with Regulatory Affairs staff and contributing functional areas to assure adequate prioritization, scheduling, preparation and dispatch of regulatory submissions
Lead and/or assist with other projects and activities as assigned by management to support the Regulatory Operations function.
- Experience in publishing and compilation of eCTD submissions and experience publishing ex-US electronic submission is desirable 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 Ability to multi-task, pay close attention to detail, and follow projects through to completion. Ability to work in a team environment with changing timelines and priorities Maintain familiarity with current regulatory submission standards and industry best practices. Use knowledge gained from industry standards and evolving regulatory guidance to contribute to departmental best practices.
Minimum of Experience within Regulatory Affairs function (preferred), with a minimum of 3 years within the biotechnology or pharmaceutical industry preferred.
- Bachelor's degree preferred