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Manager Regulatory Affairs Cmc Jobs in Texas

Regulatory Affairs Manager Jobs
By Brunel At Dallas-Fort Worth Metroplex, United States
5+ years of progressive regualtory affairs experience
Submissions experience - EU and International markets
Oversee the regualtory function for full product portfolio, managing a team, department and budget
Coordinate regulatory submissions in US and OUS markets
Provide regulatory input/support for audits
Regulatory strategy for product development
Associate Director Global Regulatory Cmc - Cell Therapy
By Shepherd Regulatory Search At Greater Boston, United States
Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
Minimum of 10 years of pharmaceutical/biotech experience, including five years of Global Regulatory Affairs (CMC) experience.
Experience as a RA CMC product lead.
Experience in Cell or Gene Therapy.
Staff Psychiatrist Out Pat-Cmc
By UTMB Health At , Dallas, 75241, Tx

Eligible for Board Certification in Psychiatry.

Current full/unrestricted Texas Medical License.

Are you looking for an exciting opportunity to join a dynamic team and make a real impact in the field of Regulatory Affairs CMC? We are looking for a Manager Regulatory Affairs CMC to join our team and help us shape the future of our company. You will be responsible for developing and implementing regulatory strategies for CMC activities, ensuring compliance with applicable regulations, and providing regulatory guidance to internal and external stakeholders. If you have a passion for regulatory affairs and a drive to make a difference, this is the job for you!

Overview:

The Manager Regulatory Affairs CMC is responsible for providing regulatory guidance and support to the organization in the development and maintenance of CMC (Chemistry, Manufacturing, and Controls) regulatory strategies. This role will ensure that the organization is compliant with all applicable regulations and guidelines, and will provide guidance on CMC regulatory activities.

Detailed Job Description:

The Manager Regulatory Affairs CMC will be responsible for developing, implementing, and maintaining CMC regulatory strategies for the organization. This role will provide regulatory guidance and support to the organization in the development and maintenance of CMC regulatory strategies. The Manager Regulatory Affairs CMC will be responsible for ensuring that the organization is compliant with all applicable regulations and guidelines, and will provide guidance on CMC regulatory activities. This role will also be responsible for preparing and submitting regulatory documents to the relevant regulatory authorities, and for monitoring and responding to regulatory changes.

What is Manager Regulatory Affairs Cmc Job Skills Required?

• Knowledge of CMC regulatory requirements and guidelines
• Excellent written and verbal communication skills
• Ability to work independently and as part of a team
• Ability to manage multiple projects simultaneously
• Strong organizational and problem-solving skills
• Ability to work in a fast-paced environment

What is Manager Regulatory Affairs Cmc Job Qualifications?

• Bachelor’s degree in a related field
• 5+ years of experience in a regulatory affairs role
• Knowledge of CMC regulatory requirements and guidelines
• Experience in preparing and submitting regulatory documents
• Knowledge of FDA and other regulatory requirements

What is Manager Regulatory Affairs Cmc Job Knowledge?

• Knowledge of CMC regulatory requirements and guidelines
• Knowledge of FDA and other regulatory requirements
• Knowledge of pharmaceutical development processes
• Knowledge of Good Manufacturing Practices (GMP)

What is Manager Regulatory Affairs Cmc Job Experience?

• 5+ years of experience in a regulatory affairs role
• Experience in preparing and submitting regulatory documents
• Experience in developing and maintaining CMC regulatory strategies
• Experience in monitoring and responding to regulatory changes

What is Manager Regulatory Affairs Cmc Job Responsibilities?

• Develop, implement, and maintain CMC regulatory strategies for the organization
• Provide regulatory guidance and support to the organization in the development and maintenance of CMC regulatory strategies
• Ensure that the organization is compliant with all applicable regulations and guidelines
• Prepare and submit regulatory documents to the relevant regulatory authorities
• Monitor and respond to regulatory changes