- Reference: GY44854
- Job Type: Permanent
- Location: Mayo
- Category: Science, Pharmaceutical & Food
This will be an initial 1 year fixed term contract. The candidate, under general supervision, performs limited or routine duties for providing Chemistry, Manufacturing, and Controls (CMC) information for regulatory applications. Compiles and performs primary review of CMC sections of regulatory submissions and develops relationships with other departments and the Regulatory Agencies to assist in the definition of CMC regulatory strategy.
- Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and applicable state, federal and local laws.
- Coordinates activities to provide required CMC sections for accurate and timely filing of Regulatory submissions.
- Responsible for preparing and filing CMC amendments or supplements to unapproved applications as required.
- Responsible for communicating pertinent conditions of regulatory approvals to other departments.
- Responds to inquiries of a CMC regulatory nature from other departments.
- Establishes, develops and maintains liaison relationships with the Regulatory Agencies.
- Establishes, develops and maintains relationships with other departments.
- Acquires and maintains knowledge and understanding of current and proposed regulations.
- Serves on project teams as the CMC regulatory team member.
- Ensures compliance with all Company policies and procedures, including safety rules, federal, state and local regulations.
- Performs related duties as assigned.
Skills, Experience and Qualifications:
- Bachelor’s Degree in a related field from an accredited college or university.
- At least 5 years experience in pharma industry preferably in Regulatory, however experience in QA, QC laboratory, formulation develop, pharm tech is acceptable.
- Responding to routine inquiries from management, employees and regulatory agencies.
- Communicating clearly and concisely, both orally and in writing.
- Operating personal computers.
- Managing multiple projects, duties and assignments.
- Applying Federal, state and local policies, procedures, laws and regulations.
- Establishing and maintaining cooperative working relationships with others.
- Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
For a confidential discussion and more information on the role/company please email your CV to: email@example.com