Senior Strategist - Regulatory Affairs (CMC)

ClinChoice; Kansas City (KS); On-site; USD 90,000 - 130,000; Full time

Job summary

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.

Qualifications

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

Responsibilities

• 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

Skills

Herbal product development

Regulatory filings

Education

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

RAPS certification

Job description

• Manage the preparation and submission of new product registrations, post approval submission, and follow-up closely on queries and through approval
• Responsible for reviewing and writing CMC modules 2 and 3
• Exposure to EU and CIS region in regulatory filings
• Manage and coordinate product life cycle management
• Ensure regulatory compliance with local regulatory requirements
• Foster and maintain professional relationships with the health authorities
• Provide regulatory support including timely registration of new product and line extensions to support new product launches and tender applications when necessary
• Maintain regulatory work processes and tracking tools that improve performance levels and transparency
• Exposure in writing of Product Quality Review
• Promote regulatory intelligence in both local and regional initiatives
• 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
• Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met
• Ensure adherence to timelines and quality set parameters R
• eview of formulation, generation of ingredient list, and claims per set standards
• Compilation and review of labeling components per SOP
• CMC modules 2 and 3
• Management of the preparation and submission of new product registrations, post approval submissions, and follow-up on queries through approval
• Review of CMC modules
• 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

Responsibilities:

• Manage the preparation and submission of new product registrations, post approval submission, and follow-up closely on queries and through approval
• Responsible for reviewing and writing CMC modules 2 and 3
• Exposure to EU and CIS region in regulatory filings
• Herbal product development background
• Manage and coordinate product life cycle management
• Ensure regulatory compliance with local regulatory requirements
• Foster and maintain professional relationships with the health authorities
• Provide regulatory support including timely registration of new product and line extensions to support new product launches and tender applications when necessary
• Maintain regulatory work processes and tracking tools that improve performance levels and transparency
• Exposure in writing of Product Quality Review
• Promote regulatory intelligence in both local and regional initiatives
• 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
• Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met
• Ensure adherence to timelines and quality set parameters R
• eview of formulation, generation of ingredient list, and claims per set standards
• Compilation and review of labeling components per SOP

Deliverables:

• CMC modules 2 and 3
• Management of the preparation and submission of new product registrations, post approval submissions, and follow-up on queries through approval
• Review of CMC modules
• 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

Experience/Qualifications:

• Bachelor’s/Master’s degree in Life Science/Pharma
• Six to eight years of relevant work experience
• RAPS certification is desirable