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Regulatory Manager / Senior Regulatory Manager

1 month ago
Romania
Full-time
Senior
Compliance Manager
Project and Program Management
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 31

Description

  • Provide regulatory guidance throughout the clinical development lifecycle.
  • Compile, coordinate, and review submissions including CTAs/INDs, amendments, annual reports, scientific advice requests, orphan designations, paediatric plans, and marketing applications.
  • Develop and review documents for Regulatory Authorities and Ethics Committees to ensure compliance with applicable standards.
  • Represent Global Regulatory Affairs in internal, client, project team, and business development meetings.
  • Lead regional or global regulatory projects and oversee Regulatory Affairs Specialists.
  • Maintain project plans, trackers, and regulatory intelligence tools while updating Regulatory Leadership.
  • Support staff development, ICH GCP training, quality initiatives, and company regulatory standards.
  • Provide input on regulatory strategies and timelines for new study opportunities.
  • Monitor changes in drug development laws, regulations, and guidelines.

Requirements

  • Bachelor’s degree or equivalent experience, ideally in a scientific or healthcare discipline.
  • 5+ years of regulatory experience for Manager level or 7+ years for Senior Manager level.
  • Regulatory affairs experience within a CRO or pharmaceutical company, including leadership of clinical submissions.
  • Knowledge of the drug development process and regulatory activities in at least one major region, such as the EU or US.
  • Experience with INDs/CTAs, amendments, scientific advice procedures, and post-approval submissions.
  • Ability to interpret clinical and preclinical study results for regulatory strategy.
  • Knowledge of clinical trial methodology, protocols, indications, and pharmaceutical development regulations.
  • Strong interpersonal, organizational, presentation, written, and verbal English communication skills.
  • Ability to manage multiple priorities independently, resolve project issues, and meet deadlines in a fast-moving environment.
  • Availability for domestic and international travel, including overnight stays.

Benefits

  • Remote work opportunity.
  • Employee ideas and contributions are valued and supported.
  • Equal opportunity employer with reasonable accommodation available for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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