Regulatory Manager / Senior Regulatory Manager

5 hours, 50 minutes ago
Full-time
Senior
Operations
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised

Description

  • Provide regulatory strategy and guidance throughout the clinical development lifecycle.
  • Compile, coordinate, and review submissions including INDs/CTAs, 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.
  • Represent Global Regulatory Affairs in internal, client, project, and business development meetings.
  • Lead regional or global regulatory projects and oversee Regulatory Affairs Specialists.
  • Maintain project plans, trackers, and regulatory intelligence tools, providing updates to regulatory leadership.
  • Support staff development, regulatory training, and ICH GCP guidance for internal and external clients.
  • Contribute to regulatory timelines, company standards, quality initiatives, and process improvements.
  • Monitor evolving drug development laws, regulations, and guidelines.

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 in 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.
  • 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 project management, communication, presentation, organization, and prioritization skills.
  • Availability for domestic and international travel, including overnight stays.

Benefits

  • Annual salary 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 and vacation.
  • Remote work opportunity.

Interested in this position?

Apply directly on the company website

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