Regulatory Strategy Lead – Global CMC & Submissions

ClinChoice; Kansas City (KS); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

ClinChoice in the United States is seeking a Regulatory Affairs professional to manage the preparation and submission of new product registrations, post-approval submissions, and to respond to queries through approval.

You will review CMC modules 2 and 3, support product lifecycle management, ensure local regulatory compliance, and coordinate with health authorities and regional teams to enable launches and tenders.

Competenze

• Bachelor’s or Master’s degree in Life Science or Pharmacy.
• Six to eight years of relevant regulatory work experience.
• RAPS certification is desirable.

Mansioni

• Manage the preparation and submission of new product registrations, post approval submissions, and follow-up on queries through approval
• Responsible for reviewing and writing CMC modules 2 and 3
• Exposure to EU and CIS region in regulatory filings
• Maintain regulatory work processes and tracking tools that improve performance levels and transparency
• Develop regulatory strategies, prepare regulatory applications, and support maintenance activities within relevant therapy areas
• Execution of regulatory strategies (local and regional) that are in line with the business plan
• Compilation of PQR as per SOP – Summary report of variations submitted as per the specified period.
• Review of formulation, generation of ingredient list, and claims per set standards
• Compilation and review of labeling components per SOP

Conoscenze

Herbal product development

Regulatory filings

Formazione

Bachelor’s/Master’s degree in Life Science/Pharma

RAPS certification

Descrizione del lavoro

ClinChoice in the United States is seeking a Regulatory Affairs professional to manage the preparation and submission of new product registrations, post-approval submissions, and to respond to queries through approval.

You will review CMC modules 2 and 3, support product lifecycle management, ensure local regulatory compliance, and coordinate with health authorities and regional teams to enable launches and tenders.