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CMC Submissions Lead
2 days ago
Takeda Manufacturing USA, Inc. is seeking a highly skilled CMC Submissions Lead to join our team in a full-time capacity. As a key member of our regulatory affairs team, you will be responsible for ensuring the timely and accurate submission of CMC Module 3 information to regulatory authorities.
Key Responsibilities:- Develop and maintain a regulatory submission content plan, timeline, and submission strategy for CMC Module 3 information.
- Establish a submission structure in electronic common technical document format for CMC Module 3 information.
- Lead cross-functional authoring teams to create and maintain regulatory submission content.
- Verify content and ensure functional approval.
- Collaborate with internal stakeholders to ensure compliance with global regulatory guidelines, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and regulatory requirements for New Drugs.
- Stay up-to-date with U.S. drug laws, FDA regulations, and data expectations for pharmaceutical products.
- Master's degree in Pharmaceutical Sciences, Regulatory Affairs, or a related field.
- At least 2 years of experience in a related field, with prior experience in regulatory affairs, pharmaceutical sciences, or a related field.
- Strong knowledge of global regulatory guidelines, GDP, GMP, and regulatory requirements for New Drugs.
- Excellent written and oral communication skills, with the ability to create and maintain regulatory submission content.
- Ability to manage cross-functional authoring teams and lead kick-off meetings, roundtable discussions, and content/data reconciliation.
- A competitive salary range of $144,500 - $186,000 per year.
- The opportunity to work with a leading pharmaceutical company in a dynamic and collaborative environment.
- A comprehensive benefits package, including health insurance, retirement savings, and paid time off.
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