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Regulatory Operations Manager (remote)

Employer
Pharmaceutical Company
Location
Milwaukee
Salary
Competitive

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Specialty Pharmaceutical Company has remote contract role for 6 months (to start; often go longer)

CORE ACCOUNTABILITIES:
  • Manage and performs daily operational activities for regulatory submissions (project management, resource scheduling, formatting, publishing, QC, archive and submission); may support global regulatory submissions
  • Collaborates with interdisciplinary teams, international colleagues, vendors and Regulatory Affairs in the management of submission components and tracking of deliverables
  • Ensure consistency, completeness, and adherence to agency guidelines, internal work instructions and SOPs
  • Ability to manage and prioritize multiple tasks in a fast-paced environment while keeping with submission timelines
  • Evaluate, author and review SOPs, Guidelines and Work Instructions to ensure regulatory documents, submissions, and systems are well-controlled and comply with applicable regulations
  • Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues
  • Stay current with new electronic submission and regulatory documentation practices issued from health authorities
?? Author, review and maintain training materials for Regulatory systems
?? Provide companywide individual and group training on EDMS
?? Review, test, and implement new software releases and upgrades for Regulatory owned systems
?? Assumes other relevant assignments as directed by the Head of Regulatory Operations
?? Maintain tracking documents as well as publishing and submission calendars
  • Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
  • Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
?? Make Intercept a truly desired place to work

QUALIFICATIONS:
  • Bachelor's degree with 6 years of experience in the pharmaceutical industry, 5 years in regulatory operations, preferred; or equivalent combination of education and industry experience.
  • Experience with electronic submission building tools, document formatting and publishing standards
?? Experience using electronic document management system (EDMS)

REQUIRED KNOWLEDGE AND ABILITIES:
  • Experience with electronic submissions, advanced PDF publishing tools, creating/maintaining templates, and management of EDMS
  • Requires knowledge of applicable Regulatory Agency regulations, guidelines, and specification (FDA, HC, EMA, ICH, etc)
  • Strong technical aptitude, preferably with extensive exposure to Microsoft Word, Adobe Acrobat and the use of PDF Processing Tools (ToolBox), eCTD validation and viewers
  • Works independently, is able to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure
?? Ability to independently problem solve and offer solutions to functional leaders and collaborators.
  • Knowledge of the regulations and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities
?? May be required to work overtime in order to meet company deadlines, as needed
?? Strong verbal and written communications skills
?? Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
  • Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
?? Ability to have fun and thrive in a growing, diverse and inclusive work environment

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