Job Description
Our client, a global pharmaceuticals manufacturer based in Connacht, now seeks a Regulatory Affairs Specialist who will perform 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.
The successful candidate will work collaboratively with the site leadership team to ensure the company strategic objectives are achieved. This hire will attend site leadership meetings ensuring effective implementation of site strategic plan.
This is a 12 month contract role, based in Connaught.
Responsibilities for CMC Regulatory Affairs Specialist:
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 other departments and Regulatory Agencies.
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.
Requirements for CMC Regulatory Affairs Specialist:
Bachelor's Degree in a related field from an accredited college or university
Regulatory environment, regulatory submissions and/or pharmaceutical and healthcare environment.
5 years' experience in pharma industry preferably in Regulatory, however experience in QA, QC laboratory, formulation develops, pharm tech is acceptable.
Current regulatory submission requirements in the US and key international environments.
Business, scientific and personal computer hardware and software applications.
Responding to routine inquiries from management, employees and regulatory agencies.
Communicating clearly and concisely, both orally and in writing.
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 further details, please contact Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website http://www.rftgroup.ie/
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