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Sr. Manager, Regulatory Operations

Lake Forest, IL

Posted: 03/15/2019 Job Category: Clinical: Regulatory Job Number: 2257

The Senior Manager, Regulatory Operations is responsible for assisting in the compilation of compliant and complex submissions to global regulatory health authorities including but not limited to advanced paper publishing and working with third-party resources for electronic publishing.  Additionally assisting in the development, implementation and maintenance of processes for enterprise document management systems (eDMS) including oversight of the strategic and operational compilation of regulatory documentation. 

JOB RESPONSIBILITIES:
  • Assist in overseeing project submission timelines, schedules and regulatory submission processes.
  • Administer enterprise document management tasks including file transfer, off-site storage, tracking and correspondence archival.
  • Assist in identifying and implementing new technology platforms, including content management and publishing systems.
  • Oversee compliant submissions to global regulatory agencies including advanced paper publishing and working with third-party resource for electronic publishing.
  • Perform quality assurance of submission documents and published output including formatting, navigation and dataset completeness.
  • Assist with development and implementation of processes related to submission standards, working practices and quality controls.
  • Maintain familiarity with current and future global regulatory submission standards.

REQUIREMENTS / QUALIFICATIONS:
  • Bachelor’ s degree or equivalent in life sciences or technology-related discipline.
  • 6 years’ pharmaceutical industry experience.
  • 5 years’ regulatory affairs operations experience.
  • Regulatory eCTD publishing knowledge and experience.
  • Knowledge and experience with enterprise document management systems (eDMS), preferably Veeva RIM.
  • Knowledge of U.S. and international regulations including cGMP, GCP, GLP, ICH guidance documents.
  • Knowledge and understanding of global regulatory submission formats, industry standards, guidelines, validation concepts, and publishing best practices including eCTD format and registration tracking.
  • Ability to work with high level contacts and exposure to sensitive information necessitating considerable use of tact, diplomacy, discretion and judgment.
  • Experience with effective project team participation and management oversight.
  • Strong interpersonal skills.
  • Professional, proactive demeanor.
  • Excellent written and verbal communication skills.
  • Proficient in Microsoft Windows environment including, but not limited to: Office 365 Products including MS Visio, Adobe Acrobat and plug-ins; enterprise class electronic document management systems, preferably Veeva RIM/Documentum; publishing product lines (eCTDXPress and DocuBridge experience a plus). Ability to learn new technology and apply to business needs.

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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