Regulatory Writer

October 31

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Stirling Q&R Ltd

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Quality • Regulatory • Pharmaceuticals • Biotechnology • Medical Devices

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Description

• Position Title: • Regulatory Writer • Company Overview: • Stirling Q&R is looking for a meticulous and skilled Regulatory Writer to join our team. • In this role, you will be instrumental in preparing high-quality regulatory documents that ensure compliance with industry standards and support our clients' product development efforts in the pharmaceutical and biotech sectors. • Key Responsibilities: • Write, edit, and review regulatory documents, including INDs, BLAs, CTDs, and clinical study reports. • Collaborate with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance, to gather necessary information for document preparation. • Ensure all documents are compliant with relevant regulatory guidelines and company standards. • Conduct literature searches and summarize findings to support regulatory submissions. • Monitor project timelines and deliverables, ensuring timely submission of documents. • Maintain a thorough understanding of regulatory requirements and updates related to document preparation. • Participate in meetings with regulatory agencies as needed to provide clarification on submitted documents.

Requirements

• Bachelor's degree in a relevant scientific field; advanced degree preferred. • 3+ years of experience in regulatory writing within the pharmaceutical or biotech industry. • Proven expertise in preparing regulatory documents for submission to health authorities. • Exceptional writing and editing skills with a strong attention to detail. • Ability to distill complex scientific data into clear and concise language. • Strong organizational and time management skills to handle multiple projects simultaneously. • Proficient in Microsoft Office Suite and document management systems. • Familiarity with eCTD submission formats. • Certification in regulatory writing or a related field.

Benefits

• Private Health Insurance • Pension Plan • Work From Home