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Regulatory Manager / Senior Regulatory Manager

1 hour, 40 minutes ago
Poland
Full-time
Senior
Program Manager
Project and Program Management
Apply Now
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
View All Jobs 88

Description

  • Provide regulatory guidance throughout the clinical development lifecycle.
  • Compile, coordinate, and review submissions to Regulatory Authorities, including CTA/INDs, annual reports, routine amendments, scientific advice meetings, orphan designations, paediatric planning, and marketing applications.
  • Develop and review regulatory documents for submission to Regulatory Authorities and Ethics Committees to ensure compliance with applicable standards.
  • Represent Global Regulatory Affairs in project team meetings with internal and external stakeholders.
  • Lead regional or global projects when needed and coordinate work within project teams.
  • Oversee Regulatory Affairs Specialists to help achieve submission targets for contracted programs.
  • Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership updated.
  • Assist in the development of Regulatory Affairs Specialists and other operational staff.
  • Contribute to regulatory strategy and timeline development for new study opportunities.
  • Support corporate quality initiatives and help establish standards for high-quality submitted information.
  • Stay current on 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 required for Manager level; 7 years required for Senior Regulatory Manager level.
  • Experience working in regulatory affairs for a Clinical Research Organisation (CRO).
  • Experience leading clinical submissions.
  • Informed 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 support regulatory positions and strategy.
  • Working knowledge of clinical trial methodology, protocols, and the indications being studied.
  • Knowledge and expertise in regulations and guidance supporting pharmaceutical development.
  • Computer literacy with MS Office / Office 365.
  • Fluent in English.
  • Graduate or postgraduate degree preferred.
  • Basic understanding of financial management preferred.
  • Availability for domestic and international travel, including overnight stays.

Benefits

  • Discretionary annual bonus.
  • Private medical insurance.
  • MultiSport Card.
  • Life insurance.
  • Pension.
  • Home working allowance.
  • Vacation / paid time off.
  • Poland salary range of 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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