Associate Director Regulatory Operations Submission Manager
Associate Director Regulatory Operations Submission Manager
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Job Description
Description
Job Title:
Associate Director Regulatory Operations Submission Manager
Location:
San Diego CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
Regulatory
P
Profoundly Improve Peoples lives by Revolutionizing the Delivery of RNA Therapeutics
At Avidity Biosciences we are passionate about the impact of every employee in realizing our vision of improving peoples 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 solutionoriented 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.
Avidity Biosciences Inc.s mission is to profoundly improve peoples lives by delivering a new class of RNA therapeutics Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform Avidity demonstrated the firstever 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 inSan Diego CA.For more information about our AOC platform clinical development pipeline and people please visit www.aviditybiosciences and engage with us on LinkedIn and Twitter.
The Opportunity
The 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 crossfunctional 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 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 crossfunctional 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 crossfunctional 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
Bachelors 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 postmarket 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 followthrough 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 problemsolving skills.
Ability to multitask shift priorities and work in a fastpaced environment.
Ability to travel to the San Diego office 34 times per year.
What We Will Provide To You
The base salary range for this role is $171000 $189000. 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 jobspecific training offered by industry and an education reimbursement program.
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego CA
92121
O:
F:
Required Experience:
Director
Employment Type
Full-Time
