Real
Associate Global Regulatory Affairs (CMC)
Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully. Join to apply for the
Associate Global Regulatory Affairs (CMC)
role at
Real .
This range is provided by Real. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $90.00/hr - $110.00/hr
Role Overview Under the guidance of the Director of Regulatory Affairs, the Associate will lead and support key Regulatory CMC activities, focusing on the development of Core Dossiers and preparation of Module 3 documents for global regulatory submissions. This role is critical in ensuring regulatory compliance and strategic alignment across Takeda's development and manufacturing programs.
Key Responsibilities
Lead the creation and management of Core Dossiers for Module 3, ensuring timely and high-quality documentation to support regulatory submissions.
Provide regulatory support for health authority interactions and contribute to the preparation of responses and briefing materials.
Collaborate with internal teams-Product Development, QA, QC, and Manufacturing-to ensure regulatory requirements are integrated into development and submission strategies.
Support development programs by ensuring products are manufactured and studied in compliance with global regulatory standards.
Manage the preparation and timely submission of regulatory applications to meet corporate milestones.
Partner with EU and international regulatory colleagues to ensure global alignment and contribute to the preparation of region-specific documentation.
Review and approve technical documentation, including validation protocols, technology transfer documents, manufacturing records, and labeling content, ensuring regulatory compliance.
Serve as a regulatory CMC advisor to cross-functional project and product teams.
Qualifications
Bachelor's, Master's, or PhD in Biochemistry, Chemistry, Biology, or a related pharmaceutical discipline.
Minimum of 4 years of experience in pharmaceutical product development, with significant expertise in CMC regulatory affairs and a strong background in biologics.
Experience in leading regulatory authority interactions is preferred.
In-depth knowledge of ICH and FDA guidelines related to CMC aspects of drug development and lifecycle management.
Proven ability to work effectively with cross-functional teams and external regulatory bodies.
EOE Statement:
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.
To find out more about Real, please visit www.realstaffing.com
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science, Strategy/Planning, and Writing/Editing
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully. Join to apply for the
Associate Global Regulatory Affairs (CMC)
role at
Real .
This range is provided by Real. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $90.00/hr - $110.00/hr
Role Overview Under the guidance of the Director of Regulatory Affairs, the Associate will lead and support key Regulatory CMC activities, focusing on the development of Core Dossiers and preparation of Module 3 documents for global regulatory submissions. This role is critical in ensuring regulatory compliance and strategic alignment across Takeda's development and manufacturing programs.
Key Responsibilities
Lead the creation and management of Core Dossiers for Module 3, ensuring timely and high-quality documentation to support regulatory submissions.
Provide regulatory support for health authority interactions and contribute to the preparation of responses and briefing materials.
Collaborate with internal teams-Product Development, QA, QC, and Manufacturing-to ensure regulatory requirements are integrated into development and submission strategies.
Support development programs by ensuring products are manufactured and studied in compliance with global regulatory standards.
Manage the preparation and timely submission of regulatory applications to meet corporate milestones.
Partner with EU and international regulatory colleagues to ensure global alignment and contribute to the preparation of region-specific documentation.
Review and approve technical documentation, including validation protocols, technology transfer documents, manufacturing records, and labeling content, ensuring regulatory compliance.
Serve as a regulatory CMC advisor to cross-functional project and product teams.
Qualifications
Bachelor's, Master's, or PhD in Biochemistry, Chemistry, Biology, or a related pharmaceutical discipline.
Minimum of 4 years of experience in pharmaceutical product development, with significant expertise in CMC regulatory affairs and a strong background in biologics.
Experience in leading regulatory authority interactions is preferred.
In-depth knowledge of ICH and FDA guidelines related to CMC aspects of drug development and lifecycle management.
Proven ability to work effectively with cross-functional teams and external regulatory bodies.
EOE Statement:
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.
To find out more about Real, please visit www.realstaffing.com
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science, Strategy/Planning, and Writing/Editing
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr