Associate Director Regulatory Operations Submission Manager

Company: Initial Therapeutics, Inc.
Location: San Diego
Posted on: April 1, 2025

Job Description:

Job Title:Associate Director Regulatory Operations Submission ManagerLocation:San Diego, CA / Hybrid / RemotePosition type:Full timeFLSA:ExemptDepartment:RegulatoryID:8300-2024-2-PStrive to Bring a Profound Difference to our PatientsAt Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.The OpportunityThe Senior Manager/Associate Director Regulatory Operations Submissions Manager will report to the Director of Regulatory Operations. This position will partner with Regulatory Affairs and collaborate with cross-functional Subject Matter Experts as the department expands submission management capabilities. This position will serve as an integral team leader during submission planning, timeline development, and execution of submission plans, through the Avidity product lifecycle.What You Will Contribute

• Key leadership role in newly formed Global Regulatory Submission Team to ensure robust submission content plans are developed and implemented to enable high quality global regulatory submissions (IND, BLA, MAA) to be executed successfully and on time to enable global product development through commercialization and beyond.
• Collaborate with regulatory strategists and cross-functional SMEs on matrix team to develop submission content plans and timelines for submissions across all submission modules that align to program requirements.
• Develop, manage, and implement agile regulatory project management tools, using software such as MS Project, Excel, SmartSheet, and Veeva Content Plans.
• Effectively monitor progress, evaluate and develop timelines, schedules, risks, and objectives. Ensure alignment with internal and external stakeholders and project teams.
• Migrate historical documents into Veeva RIMS, as needed, and manage document workflows to support product lifecycle submissions.
• Represent the regulatory operations function on cross-functional teams.
• Interface with key external stakeholders as needed.
• Contribute to ongoing process improvement and department initiatives, including SOP review and development, user guides, best practices, development and delivery of user community training materials.
• Proactively communicate and coordinate resource allocation, ensuring timely deliverables are achieved.
• Review project related plans to ensure best practices, standardization, and consistency across the project.What We Seek
• Bachelor's Degree preferred with ability to understand scientific principles.
• 6+ years of industry experience working in regulatory information management, regulatory project management, and submissions systems.
• Veeva RIM Vault experience highly preferred.
• Proficient in Microsoft 365 Suite including SharePoint, Outlook, Word, Excel, PowerPoint, Smartsheet and experienced with virtual platforms like Zoom and Teams.
• Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.
• At least two marketing application submissions in the USA or more jurisdictions.
• Understanding of regulatory standards/requirements relevant to global drug development and post-market support is needed.
• Demonstrated strong ability to collaboratively lead with line support, interact and work effectively with other departments as well as external organizations.
• Excellent organizational skills, attention to detail, and demonstrated capability to manage multiple projects within assigned timelines.
• Ability to prepare documents for regulatory submission including launching templates, Word formatting, confirmation of accuracy of bookmarking, hyperlinking, and general submission functionality.
• Effectively collaborate in a highly matrixed organization.
• Lead productive and efficient meetings with regulatory and SME attendees to enable problem solving and visibility to project status.
• Demonstrated ability to develop, execute, and follow-through complex projects to completion.
• Skilled in utilizing eCTD publishing tools, including Starting Point, Adobe Acrobat, Toolbox, and Veeva Vault RIM Publishing.
• Demonstrated competency with project and stakeholder management including internal and contracted or external stakeholders.
• Excellent oral and written communication, teamwork, organizational, interpersonal, and problem-solving skills.
• Ability to multi-task, shift priorities, and work in a fast-paced environment.
• Ability to travel to the San Diego office 3-4 times per year.What We Will Provide To You
• The base salary range for this role is $171,000 - $189,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Avidity offers competitive compensation and benefits, which include the opportunity for annual and spot bonuses, stock options, and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
• A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.Avidity Biosciences10578 Science Center Dr. Suite 125San Diego, CA 92121O: 858-401-7900F: 858-401-7901
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Keywords: Initial Therapeutics, Inc., San Diego , Associate Director Regulatory Operations Submission Manager, Executive , San Diego, California