Senior Regulatory Affairs Specialist

February 5

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Syner-G BioPharma Group

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Syner-G BioPharma Group is the world's leading provider of chemistry, manufacturing and controls (CMC), regulatory affairs, and medical writing solutions for the biopharma sector. They offer comprehensive services that navigate clients through the complexities of pharmaceutical development, regulatory submissions, and quality compliance, ensuring high-quality outcomes. With a multidisciplinary team, Syner-G integrates science, engineering, and regulatory expertise to support drug development from pre-IND to post-approval phases, enabling timely submissions and patient safety adherence.

cGMP Solutions • Regulatory Science for Pharm Development • CMC Formulation Development • Post-Approval CMC • Medical Writing Services

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• The Senior Regulatory Affairs Specialist, CMC is responsible for providing regulatory CMC support through the product life cycle. • These job responsibilities include but are not limited to regulatory strategies, submission timeline development, change control, and preparing submission documents.

🎯 Requirements

• A Bachelor’s degree in a health or life science discipline is required; Advanced degree is preferred. • 5+ years of experience in the pharmaceutical industry in research, manufacturing, analytical, or quality. • 2+ years of experience in Regulatory-CMC. • Ability to read, analyze and interpret technical documents and health authority regulations. • Demonstrated experience authoring CMC sections in Module 1, 2 and 3 sections of regulatory filings required. • Familiar with Common Technical Document (CTD) formatting. • Working knowledge of the US and European regulations and ICH guidance is preferred. • Demonstrated experience using regulatory systems and tools (e.g., TrackWise and Veeva Vault are preferred). • Strong computer proficiency in the use of the MS Office Suite (Word, Outlook, PowerPoint, and Excel).

🏖️ Benefits

• Market competitive base salary and annual incentive plan. • Robust benefit offerings. • Ongoing recognition and career development opportunities. • Generous flexible paid time off program. • Company paid holidays. • Flexible working hours. • Fully remote work options for most positions and the ability to work “almost anywhere”. • Office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.