Senior Manager/Manager Regulatory Document Submissions at Avidity Biosciences

Job Title: 

Senior Manager/Manager Regulatory Document Submissions 

Location: 

Remote 

Position type: 

FLSA: 

Full time  

Exempt  

Department: 

Regulatory Affairs 

At Avidity Biosciences, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.  

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). 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. Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter. 

Position Overview 

The Senior Manager/Manager Regulatory Document Submissions will report to the Director of Medical Writing, Regulatory. This position will partner with Regulatory Affairs as the department brings publishing and submissions in-house. This position will serve as an integral team member during system configuration, validation, and migration of historical documents into Veeva. Once the system is implemented, administration responsibilities will include ongoing system maintenance and development through regular meetings with the Veeva support team, validation of new system functions when added, and collaboration efforts with RA strategists, medical writers, IT, on methods to optimize RIM system use. Additionally, post implementation the role will expand into submissions management. 

What You Will Contribute 

• Validation and administration of Veeva vault
• Migration of historical documents into Veeva
• Collaboration with regulatory strategists to develop content plans.
• Preparation of formatted documents for regulatory submission including confirmation of accuracy of bookmarking, hyperlinking, and general submission functionality.  
• Partner with stakeholders to identify, manage, escalate, and resolve issues related to Veeva processes and functionality.
• Effectively collaborate in a highly matrixed organization
• Represent the regulatory 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, development of training materials.
• Review project related plans to ensure best practices, standardization, and consistency across the project.

What We Seek 

• Bachelor’s Degree preferred.
• 7+ years of industry experience working in regulatory information management and submissions systems, Veeva RIM Vault experience highly preferred.
• Proficient in Microsoft 365 Suite including Teams, SharePoint, Outlook, Word, Excel, PowerPoint, and experienced with virtual platforms like Zoom.
• Skilled in utilizing eCTD publishing tools, including Adobe Acrobat, Toolbox, Liquent InSight, and Veeva Vault RIM Publishing.
• Comprehensive knowledge and understanding of FDA eCTD technical requirements and specifications.
• Demonstrated competency with project and stakeholder management including internal and contracted or external stakeholders Demonstrated 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.
• Team leadership experience within a cross-functional matrix environment

• The base salary range for this role is $126,500 – $160,100. 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 includes 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 Biosciences 

10578 Science Center Dr. Suite 125 

San Diego, CA 

92121 

O: 858-401-7900 

F: 858-401-7901