Global Regulatory Lead - Clinical Submissions

Katalyst CRO; Richmond (IL); On-site; USD 140,000 - 200,000; Full time

Job summary

Katalyst CRO seeks a Regulatory Manager to guide regulatory strategy and submissions for diverse clinical programs. You will coordinate documents for authorities and ethics committees, and provide ongoing regulatory guidance across the development life cycle.

In this role, you will lead regulatory input, ensure compliance, and collaborate with cross-functional teams to meet submission timelines while staying abreast of evolving laws and guidelines.

Qualifications

• Bachelor's degree or equivalent in a scientific/healthcare field.
• 7+ years of regulatory experience, preferably in a CRO.
• Experience leading regulatory submissions (IND/CTA) and interactions with authorities.
• Knowledge of EU/US regulatory processes and guidance documents.
• Familiarity with clinical trials methodology and regulatory milestones.
• Strong interpersonal and communication skills; able to lead teams.

Responsibilities

• Provide regulatory strategy and development guidance for clinical trials and regulatory meetings.
• Coordinate and prepare regulatory documents for submission to authorities and ethics committees.
• Maintain current knowledge of regulations; support and enhance the regulatory function.
• Lead regulatory input throughout the product lifecycle and project teams.
• Develop and review submissions for regulatory authorities to ensure compliance.
• Represent Global Regulatory Affairs at project team meetings with internal and external customers.

Skills

Regulatory strategy

Regulatory submissions

Leadership

Cross-functional collaboration

Clinical development life cycle

Education

Bachelor's degree in a scientific/healthcare discipline

Job description

Katalyst CRO seeks a Regulatory Manager to guide regulatory strategy and submissions for diverse clinical programs. You will coordinate documents for authorities and ethics committees, and provide ongoing regulatory guidance across the development life cycle.

In this role, you will lead regulatory input, ensure compliance, and collaborate with cross-functional teams to meet submission timelines while staying abreast of evolving laws and guidelines.