Associate Director, CMC Regulatory Affairs

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Job description

Job Title:Associate Director, Regulatory AffairsLocation:San Diego, CA / Hybrid / RemotePosition type:FLSA:Full time ExemptDepartment:Regulatory and QualityStrive 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. 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 OpportunityReporting to the 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

• Lead the preparation, coordination, review, and maintenance of CMC content in regulatory submissions (e.g., INDs, IMPDs and CTAs, annual reports, Briefing Documents, BLA/MAA), to ensure timelines are met
• Represent the regulatory function in CMC subteams and contribute to CMC regulatory strategies and solutions within the team
• Support responses to Health Authority inquiries
• Provide regulatory CMC advice and direction, including the interpretation and application of global CMC feedback, regulations, and guidance
• Provide regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
• Proactively identify potential CMC program and/or submission risks and implement appropriate regulatory mitigation strategies to support successful submissions
• Involvement in preparation for and management of CMC interactions with Health Authorities
• Train, mentor and supervise, as needed, employees, consultants/contractors in Regulatory Affairs
• Maintain a positive team spirit and lead by ethical principles
• Partner with stakeholders to identify, manage, escalate, and resolve issues impacting optimal team performance
• Effectively collaborate in a highly matrixed organization
• Initiate/contribute to ongoing process improvement and department initiatives within the Regulatory Affairs function, including process improvements, SOP review and development, development of training, etc.

What We Seek

• Bachelor's Degree required; Advanced Degree preferred
• 5+ years of experience in Regulatory Affairs with a CMC focus within a biotechnology company
• Established working knowledge of regulatory guidelines and regulations, US and international
• Direct experience leading regulatory CMC aspects of IND/CTA/BLA/NDA/MAA submissions, experience with both biologics and oligonucleotides strongly preferred
• Demonstrated evidence of writing CMC portions of high-quality regulatory documents
• Strong eCTD knowledge and regulatory writing skills
• Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with management, CMC, GMP Quality Assurance, and contract manufacturing organizations
• 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
• Self motivated, self disciplined, and able to function independently as well as part of a team
• 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 You:

• The base salary range for this role is $170,000 - $187,900. 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.

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