Job Title: Regulatory Submissions Specialist Job Description We are seeking a highly skilled Regulatory Submissions Specialist to manage submission-related activities, working closely with regulatory and CMC leads to create content plans and submission timelines. This role involves coordinating cross-functional review and approval cycles for regulatory documents, maintaining a regulatory calendar, and serving as the point of contact for selected regulatory vendors. The ideal candidate will have a strong background in regulatory affairs and experience with IND and BLA submissions. Responsibilities + Work with regulatory and CMC leads to create content plans and submission timelines for regulatory submissions. + Organize and facilitate kick-off meetings and comment resolution meetings for major submissions. + Support regulatory and CMC leads in content and action plans. + Coordinate cross-functional review and approval cycles for regulatory documents. + Maintain a regulatory calendar/book of work for upcoming deliverables, including medical writing (MW), regulatory, and pharmacovigilance (PV) tasks. + Serve as the point of contact and alliance manager for selected regulatory vendors, ensuring timely execution of regulatory submissions. + Finalize submission documents, review submission planners, and perform quality control on final submissions before dispatch. + Prepare regulatory calendars and books of work for vendor resource planning activities. + Attend operations meetings to review upcoming and ongoing deliverables across MW, PV, and regulatory functions. + Assist in the preparation and maintenance of quarterly regulatory dashboards. + Manage the regulatory budget under the supervision of regulatory leads and project managers. + Manage the regulatory website homepage. Essential Skills + 5 years of experience in biotech working on relevant regulatory submissions. + Experience with IND and BLA submissions. + Experience working with vendors and CROs. + Strong communication skills. + Proficiency with publishing tools. + Timeline management experience. + Experience with early and late-stage global CTA submissions. Additional Skills & Qualifications + Pharma or CRO experience is a must. + Commitment to long-term projects with potential for full-time employment. + Experience in both early and late-stage clinical trials. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.