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Manager Regulatory Affairs Cmc Jobs in New York

Regulatory Affairs Manager Jobs
By Jobot At New York, NY, United States
Strong knowledge of OTC drug and device regulations, including labeling requirements
Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred
Working knowledge of U.S. clinical research and claims support
Excellent written and verbal communication skills
6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs
Drug or medical device submission and/or maintenance experience
Regulatory Affairs Manager Jobs
By USK Technologies At New York City Metropolitan Area, United States
You will report to the Senior Manager, Quality, Safety and Regulatory Affairs.
Product development experience strongly preferred
Skin and personal care including OTC claim review experience strongly preferred
Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
Strong written communication skills, especially detail oriented and technical material
Experience communicating with cross-functional teams and customers including verbal presentations
Product Compliance & Regulatory Affairs Manager
By quip. At New York City Metropolitan Area, United States
7+ years regulatory management experience of Medical Devices, Consumer Electronics and OTC drugs
Experienced leading certification, internal, and supplier qualification audits
Lead evolution of Quality Management System and associated processes to support product, market, company, and business growth
Review product labeling, packaging, advertising, marketing, digital materials for compliance to regulatory requirements
Responsible for all regulatory aspects of NPD from concept to certification through maintenance / renewals
Lead supplier, internal, and certification/maintenance audits, as needed
Senior Director, Cmc Jobs
By BioSpace At New York, NY, United States
Identification, selection and management of CDMOs for process development, process optimization, GxP manufacturing and analytical activities for drug-substance and drug-product
Direct experience working with FDA, including knowledge of current ICH guidelines
In depth understanding of modern process development, solid state characterization, hands on cGMP manufacturing and CDMO management
Establish and manage all CMC internal and external activities related to process development, manufacturing and validation for our programs
Ph.D. in Chemistry or related discipline with at least 15+ years of industrial experience in Process Chemistry and Drug Development
Strong track record of drug discovery experience, success, and leadership, exemplified by advancement of programs through multiple stages of development
Executive Director, Global Regulatory Sciences Cmc Advisory Office
By Pfizer At , New York, 10017, Ny $219,600 - $365,800 a year
A recognized technical subject-matter expert with extensive relevant CMC regulatory experience & business knowledge.
Sufficient experience and knowledge to assess technical, scientific & regulatory merits of CMC strategies, commitments and data.
Ensuring all regulatory activities are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
Advanced Scientific Degree (M.D., Ph.D., Pharm.D., M.Sc.) or equivalent experience in the biopharmaceutical industry.
Experience negotiating with regulatory authorities.
High level of business acumen that includes development as well as commercial experience with a variety of therapeutic products.

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