Manager, CMC Regulatory Affairs

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Job description

Job Title:

Manager, Regulatory Affairs

Location:

San Diego, CA / Hybrid / Remote

Position type:

FLSA:

Full time

Exempt

Department:

Finance ID:

Regulatory and Quality

8300-Q224-4

Strive to Bring a Profound Difference to our Patients At 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.

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs ). 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 and engage with us on LinkedIn and Twitter .

The Opportunity

Reporting to an Associate Director, CMC Regulatory Affairs, the successful candidate will work independently and collaborate cross functionally to provide guidance to the CMC subject matter experts and manage and execute CMC regulatory submissions to facilitate the global development of Avidity compounds.

What You Will Contribute

• Manage preparation, drafting, and review of CMC content regulatory submissions (e.g. INDs, IMPDs, BLAs) to ensure timelines are met
• Work collaboratively with CMC subject matter experts and external partners to track source documentation and allow for successful completion of CMC regulatory submissions
• Partner with stakeholders to identify, manage, escalate, and resolve issues related to optimal team performance
• Support responses to Health Authority inquiries
• Support preparation for and management of CMC interactions with Health Authorities
• Contribute to the development of CMC strategies and solutions within program teams
• Ensure compliance with quality assurance and regulatory procedure and work practice
• Contribute to ongoing process improvement and department initiatives within the CMC Regulatory Affairs function, including process improvements, SOP review and development, development of training, etc.
• Effectively collaborate in a highly matrixed organization

What We Seek

• Bachelor's Degree, at a minimum, (advanced degree preferred) in life sciences or chemistry, with a minimum of 3 - 5 years of experience in Regulatory Affairs with a CMC focus within a biotechnology company and/or 5+ years of experience within biopharmaceutical technical operations or equivalent combination of education and experience
• Established working knowledge of regulatory guidelines and regulations, US and international
• Strong eCTD knowledge and regulatory writing skills
• Self motivated, self disciplined, and able to function independently as well as part of a team
• Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority setting to work effectively in a dynamic environment to meet aggressive timelines
• Strategic agility, strong critical and logical thinking with the ability to analyze and propose solutions to problems
• Excellent computer proficiency (MS Word, Excel, PowerPoint, Adobe Acrobat)
• Ability to travel as needed

What We will Provide to You:

• The base salary range for this role is $135,100 to $149,300. 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

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