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Regulatory Manager / Senior Regulatory Manager

1 month ago
Poland
Full-time
Senior
Compliance Manager
Operations
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, pediatric plans, and marketing applications.
  • Develop and review documents for Regulatory Authorities and Ethics Committees to ensure compliance.
  • Represent Global Regulatory Affairs in project team and business development meetings.
  • Lead regional or global projects and coordinate Regulatory Affairs Specialists to meet submission targets.
  • Maintain project plans, trackers, and regulatory intelligence tools while updating Regulatory Leadership.
  • Support regulatory strategy, timelines, company standards, quality initiatives, and process improvements.
  • Provide ICH GCP guidance, training, and advice to internal and external clients.
  • Support the development of Regulatory Affairs Specialists and other operational staff.

Requirements

  • Bachelor’s degree or equivalent experience, preferably 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 milestones.
  • Specialized regulatory experience in at least one major region, such as the EU or US, including INDs/CTAs, amendments, scientific advice, and post-approval submissions.
  • Ability to interpret clinical and preclinical study results for regulatory strategy.
  • Working knowledge of clinical trial methodology, protocols, and studied indications.
  • Knowledge of regulations and guidance supporting pharmaceutical development.
  • Strong communication, presentation, teamwork, organizational, and problem-solving skills.
  • Availability for domestic and international travel, including overnight stays.

Benefits

  • Annual compensation range of 190,200–285,400 PLN gross in Poland.
  • Discretionary annual bonus.
  • Private medical insurance and life insurance.
  • MultiSport Card and pension plan.
  • Home working allowance.
  • Vacation leave.

Interested in this position?

Apply directly on the company website

Apply Now

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