Regulatory Manager

1 day, 1 hour ago
Full-time
Senior
Project and Program Management
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 guidance throughout the clinical development life cycle.
  • Compile, coordinate, and review submissions to Regulatory Authorities, including CTA/INDs, annual reports, amendments, scientific advice requests, orphan designations, pediatric planning, and marketing applications.
  • Develop and review submission documents for Regulatory Authorities and Ethics Committees to ensure regulatory compliance.
  • Represent Global Regulatory Affairs in project team and business development meetings with internal and external stakeholders.
  • Work within project teams and lead regional or global projects when needed.
  • Oversee Regulatory Affairs Specialists to meet submission targets for contracted programs.
  • Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership updated.
  • Support 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 maintain knowledge of laws, regulations, and guidelines governing drug development and approval.
  • Provide ICH GCP guidance, advice, and training to internal and external clients.

Requirements

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

Benefits

  • $106,000 to $151,000 USD annual salary range.
  • Discretionary annual bonus.
  • Health insurance.
  • Retirement savings benefits.
  • Life insurance and disability benefits.
  • Parental leave.
  • Paid time off for sick leave and vacation.
  • Remote role (#LI-Remote).

Interested in this position?

Apply directly on the company website

Apply Now

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