Amgen Regulatory Operations Manager - Publishing in Thousand Oaks, California

Amgen is searching for a Regulatory Operations Manager - Publishing in our Global Regulatory Filing group. This role will be a remote position with occasional travel to the main corporate campus in Thousand Oaks, CA and will report to the Global Regulatory Affairs & Safety (GRAAS) Operations Senior Manager.

The Regulatory Operations Manager will ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities. This manager supports the tactical execution and detailed deliverables to support a Global Regulatory Filing. The manager will manage and deliver every submission every time.

Key responsibilities for this role include:

  • Manage the functional areas of the department

  • Manage outsourced resources

  • Take part in the career and skills development of staff members

  • Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective

  • Manage the preparation of submission ready components from internal contributors according to regional regulatory guidance and internal standards

  • Manage the creation and submission of regulatory dossiers across regions according to local requirements and agreed upon timelines

  • Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers

  • Contribute to the development of the strategy for communicating with global health authorities

  • Represent departmental expertise on global work streams

  • Initiate, lead and manage process development and improvement

  • Lead information system and software update projects as well as ongoing system validations from a publishing perspective

  • Develop and report publishing metrics to senior management

  • Provide technical support in regulatory systems

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of regulatory experience in a Pharmaceutical/Biotech Industry

OR

Bachelor's degree and 5 years of regulatory experience in a Pharmaceutical/Biotech Industry

OR

Associate's degree and 10 years of regulatory experience in a Pharmaceutical/Biotech Industry

OR

High school diploma / GED and 12 years of regulatory experience in a Pharmaceutical/Biotech Industry

Preferred Qualifications:

  • Knowledge of the industry and business principles for a regulatory operations department

  • Experience managing relationships with contributing functions and affiliates

  • Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications

  • Expertise in the submission and maintenance of global Clinical Trial and Marketing Applications

  • Strong project management skills specifically related to regulatory projects

  • Expert knowledge of eCTD, eCTD Specifications and eCTD software

  • Expert knowledge of Emerging Markets Marketing Application submission requirements, country specifications, and software used

  • Expert knowledge of International Clinical Trial and Pediatric submission requirements, country specifications, and software used

  • Expertise in MS Word, Adobe Acrobat and a variety of Acrobat related plug-ins specific to regulatory publishing

  • Experience in a regulatory operations-focused role

  • Experience liaising with global regulatory authorities as it pertains to regulatory submissions

  • Expert knowledge in regional agency requirements for submissions

  • Expertise with standard software utilized by regulatory publishing groups

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.