Regulatory Compliance Specialist
3 days ago
Axiom Software Solutions Limited is seeking a highly skilled Regulatory Support professional to join our team. The successful candidate will have a strong background in pharmaceutical regulatory affairs and experience working with FDA inspections and internal audit processes.
The estimated salary for this position is $120,000 - $180,000 per year, depending on experience. This is a full-time role based in Basking Ridge, NJ with the option to work remotely some days.
In this role, you will be responsible for ensuring compliance with company Standard Operating Procedures and regulatory agency regulations/guidance. You will represent Regulatory Affairs on cross-functional project teams and provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents.
Your duties will include gathering and assembling information necessary for submissions in accordance with regulations/guidance, reviewing documentation with a high degree of attention to detail, and conducting review of published submissions to ensure consistency and compliance with regulatory requirements.
You will maintain knowledge of local and global regulatory submission requirements and maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures & directives.
To succeed in this role, you will need a Bachelor's degree, preferably in a life science or a related field, and 5 to 10 years of experience in pharmaceutical environment with experience in regulatory environment required.
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