Regulatory Manager / Senior Regulatory Manager

5 hours, 51 minutes 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 lifecycle.
  • Compile, coordinate, and review submissions including INDs, CTAs, 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 internal, client, project team, and business development meetings.
  • Lead regional or global regulatory projects and coordinate Regulatory Affairs Specialists.
  • Maintain project plans, trackers, and regulatory intelligence tools while updating leadership.
  • Support staff development, ICH GCP training, quality initiatives, and company regulatory standards.
  • Provide input on regulatory strategies, timelines, process improvements, and new study opportunities.
  • Monitor changes to laws, regulations, and drug development 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 industry environment.
  • Experience leading clinical submissions and regulatory activities in at least one major region, such as the EU or US.
  • Knowledge of the drug development process, regulatory milestones, INDs/CTAs, amendments, scientific advice procedures, 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.
  • Strong understanding of pharmaceutical regulations and guidance.
  • Strong communication, presentation, organizational, record-keeping, and interpersonal skills.
  • Ability to manage multiple priorities independently, motivate project teams, travel domestically and internationally, and communicate fluently in English.

Benefits

  • Remote work opportunity.
  • Equal opportunity employment and reasonable accommodation support.
  • An environment where employees’ ideas and contributions are valued.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Compliance Lead (Remote)

Geotab 1K-5K Road & Rail

Geotab is seeking a Compliance Lead to operationalize global ethics and compliance programs, strengthen risk controls, and promote a culture of integrity across its connected transportation technology business.

1 day, 5 hours ago

Compliance Lead (Remote)

Geotab 1K-5K Road & Rail

Geotab is seeking a Compliance Lead to operationalize global ethics and compliance programs, investigate concerns, and embed effective controls across its connected transportation technology business.

1 day, 5 hours ago

Regulatory Manager / Senior Regulatory Manager

Precision Medicine Group 251-1K Pharmaceuticals

Precision for Medicine is hiring a Regulatory Manager or Senior Regulatory Manager to guide regulatory strategy and submissions for global clinical trials focused on oncology and rare disease therapies.

1 day, 5 hours ago

Regulatory Manager / Senior Regulatory Manager

Precision Medicine Group 251-1K Pharmaceuticals

Precision for Medicine is hiring a Regulatory Manager or Senior Regulatory Manager to guide regulatory strategy and clinical trial submissions for oncology and rare disease programs across global markets.

1 day, 5 hours ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers