Scientific Search

Compensation

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Regulatory Submissions Manager (Contract) Location: Remote Position Summary Scientific Search has partnered with a biotech company in Boston that has tasked our team in finding them an experienced Regulatory Submissions Manager to support high-priority regulatory activities, including IND/CTA and NDA submissions. This contract role will be instrumental in managing submission preparation and tracking, including rapid response initiatives, formatting regulatory documents, and maintaining submission metadata and workflows within Veeva RIM. Responsibilities • Lead and coordinate the preparation, formatting, and submission of regulatory documents (all submission types for INDs/CTAs and NDA amendments). • Manage document lifecycle and submission tracking using Veeva RIM. • Ensure documents meet global regulatory standards and formatting requirements (eCTD structure, PDF compliance). • Collaborate cross-functionally with Regulatory Affairs, CMC, Nonclinical and Clinical team members and external publishing vendor to ensure timely and accurate submissions. • Support rapid response efforts to Health Authority queries, including formatting and publishing of responses. • Maintain submission plans and ensure alignment with project timelines. • Perform quality control checks on submission-ready documents. • Assist in the development and refinement of submission templates and SOPs. Requirements • Bachelor’s degree in life sciences or related field; advanced degree preferred. • Minimum 5 years of experience in regulatory operations or submission management in the biotech/pharma industry. • Proven experience with IND and NDA submissions, including rapid response coordination. • High proficiency in Veeva RIM. • Strong knowledge of eCTD structure, FDA/EMA submission requirements, and document formatting standards. • Excellent organizational skills and attention to detail. • Strong communication and project management skills. • Ability to work independently and manage multiple priorities in a fast-paced environment. • Willing to work hours needed for submission / rapid response preparation for delivery to publishing vendor to meet required timelines. Preferred Skills • Familiarity with global regulatory requirements (FDA, EMA). • Veeva RIM report-level and submission content plans. How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to tomt@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume.