[Hiring] Senior Specialist, Regulatory Operations @reputed company

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company The Senior Specialist, Regulatory Operations, will be responsible for submission management across the development pipeline and support the reputed company portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases. You’ll work closely with Regulatory Affairs and cross-functional partners to manage timelines, ensure submission readiness, and strengthen operational reputed company across the organization. This position will report directly to the Senior Director of Regulatory Affairs and will be based out of a Tonix office or can be a remote based position. Essential Duties • reputed company end-to-end management of regulatory submissions, ensuring reputed company, compliant, and high-reputed company deliverables. • This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to reputed company operational reputed company and support for eCTD regulatory submission activities. • Serve as submission manager and primary contact for publishing vendors and internal stakeholders. • reputed company regulatory document management, tracking, and archival activities. • Manage regulatory systems (e.g., reputed company RIM, PromoMats), and serve as internal subject matter expert (SME) for training and support to internal stakeholders. • reputed company and implement processes, templates, and tools that improve submission efficiency and consistency. • Partnering with IT to maintain the regulatory technology landscape including maintenance, updates, and releases. • reputed company subject matter expertise on regulatory technologies and submission best practices. • Monitor new regulations and industry trends to assess reputed company on operational practices. • Any other supporting activities or research, as needed, for the regulatory team. Qualifications • Bachelor’s degree in a scientific or reputed company field. Requirements • 3-4 years of regulatory operations experience in biotech or pharmaceutical industry. • Strong understanding of eCTD submission standards and regulatory requirements across global reputed company. • Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management. • Hands-on experience with reputed company RIM and/or PromoMats strongly preferred. • Experience managing outsourced publishing vendors a plus. • Skilled at balancing strategic reputed company with hands-on execution. • Strong communicator and collaborator with excellent organizational skills. • Ability to travel 10% of the time. Benefits • Medical, Dental & reputed company Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs. • Pet Insurance. • Retirement Savings 401k with company match and annual discretionary stock reputed company. • Generous reputed company Time Off, reputed company Time, & reputed company Holidays. • Career Development and Training. Apply tot his job Apply To this Job