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Regulatory Manager / Senior Regulatory Manager

1 hour, 31 minutes ago
Poland
Full-time
Senior
Compliance Manager
Legal
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 154

Description

  • Provide regulatory guidance throughout the clinical development lifecycle.
  • Compile, coordinate, and review regulatory submissions such as CTA/INDs, annual reports, routine amendments, scientific advice packages, orphan designations, pediatric plans, and marketing applications.
  • Develop and review documents for submission to Regulatory Authorities and Ethics Committees to ensure compliance with regulatory standards.
  • Represent Global Regulatory Affairs in project team meetings with internal and external stakeholders.
  • Lead regional or global projects when needed and coordinate Regulatory Affairs Specialists to meet submission targets.
  • Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership informed.
  • Support development of Regulatory Affairs Specialists and other operational staff.
  • Contribute to regulatory strategy and timeline development for new study opportunities.
  • Help establish company standards to ensure the quality of submitted information.
  • Maintain awareness of laws, regulations, and guidelines governing drug development and approval.
  • Provide ICH GCP guidance, advice, and training to internal and external clients.
  • Represent Global Regulatory Affairs in business development meetings.

Requirements

  • Bachelor’s degree or equivalent experience, ideally in a scientific or healthcare discipline.
  • 5 years of regulatory experience for the Manager level or 7 years for the Senior Manager level.
  • Computer literacy with MS Office / Office 365.
  • Fluent in English.
  • Regulatory affairs experience working for a Clinical Research Organisation (CRO).
  • Experience leading clinical submissions.
  • In-depth knowledge of the drug development process, including regulatory milestones.
  • Specialized knowledge of regulatory activities in at least one major region, such as the EU or US.
  • Experience with submissions to Regulatory Authorities, including INDs/CTAs, amendments, scientific advice procedures, and post-approval submissions.
  • Ability to interpret clinical and pre-clinical study results to inform regulatory positions and strategy.
  • Working knowledge of clinical trial methodology, protocols, and indications being studied.
  • Knowledge of relevant regulations and guidance supporting pharmaceutical development.
  • Availability for domestic and international travel, including overnight stays.
  • Graduate or postgraduate education preferred.
  • Basic understanding of financial management preferred.

Benefits

  • Discretionary annual bonus.
  • Private medical insurance.
  • MultiSport Card.
  • Life insurance.
  • Pension plan.
  • Home working allowance.
  • Vacation time.
  • Remote work arrangement (#LI-Remote).
  • Annual base salary range in Poland: 190,200 PLN to 285,400 PLN gross per annum.

Interested in this position?

Apply directly on the company website

Apply Now

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