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Senior Manager, CMC Regulatory Affairs
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Senior Manager, CMC Regulatory Affairs
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Senior Manager, CMC Regulatory Affairs
Location:
San Diego, CA / Hybrid / Remote
Flsa
Position type:
Full time
Exempt
Department
Finance ID:
Regulatory Affairs
2601-Q125-9
Profoundly Improve People’s 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 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 www.aviditybiosciences.com and engage with us on LinkedIn and X.
The Opportunity
We are looking for an experienced Senior Manager of CMC Regulatory Affairs to join our dynamic team. In this pivotal role, you will report directly to the Senior Vice President of CMC Regulatory Affairs and will play a crucial part in our CMC regulatory affairs team, working closely with cross-functional partners to craft and implement comprehensive and effective CMC regulatory strategies. These strategies are essential for advancing the global development of Avidity’s diverse pipeline of innovative therapies and will help ensure that we meet regulatory requirements and drive our mission forward in a fast-paced environment.
What You Will Contribute
Lead the preparation, authoring and review of CMC content for regulatory submissions (e.g., INDs, IMPDs, BLAs), ensuring high quality and adherence to program timelines. Effectively communicate and manage the integrated submission management process, from project initiation through drafting, review, data verification and content lock ensuring adherence to program goals Collaborate closely with CMC subject matter experts to identify and track appropriate source documentation to be used in the preparation of regulatory submission materials. Support the development of responses to Health Authority inquiries in a timely and effective manner. Develop standardization of document templates and technical style guide to ensure quality and consistency across programs Contribute to continuous improvement initiatives within CMC Regulatory Affairs, including SOP development, training material creation, and workflow optimization. Review technical reports and other scientific documents as required to support readiness for regulatory submissions.
What We Seek
Bachelor’s Degree (advanced degree preferred) in life sciences, engineering or chemistry, with a minimum of 10 years of experience within a biopharmaceutical company of which 5+ years must have been in CMC Regulatory Affairs and Minimum of 4 years’ experience of being part of a team, developing and managing a BLA Strong knowledge of US and international regulatory guidelines and regulations including eCTD Strong project management skills, including deep experience of SmartSheet and Veeva RIM. Self‐motivated 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 to the San Diego corporate office as needed
What We Will Provide To You
The base salary range for this role is $166,250 - $183,750. 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.
Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionLegal IndustriesInternet News Referrals increase your chances of interviewing at BioSpace by 2x Sign in to set job alerts for “Senior Manager Regulatory Affairs” roles. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Senior Manager, CMC Regulatory Affairs
role at
BioSpace 1 day ago Be among the first 25 applicants Join to apply for the
Senior Manager, CMC Regulatory Affairs
role at
BioSpace Get AI-powered advice on this job and more exclusive features. Job Title
Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.
Senior Manager, CMC Regulatory Affairs
Location:
San Diego, CA / Hybrid / Remote
Flsa
Position type:
Full time
Exempt
Department
Finance ID:
Regulatory Affairs
2601-Q125-9
Profoundly Improve People’s 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 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 www.aviditybiosciences.com and engage with us on LinkedIn and X.
The Opportunity
We are looking for an experienced Senior Manager of CMC Regulatory Affairs to join our dynamic team. In this pivotal role, you will report directly to the Senior Vice President of CMC Regulatory Affairs and will play a crucial part in our CMC regulatory affairs team, working closely with cross-functional partners to craft and implement comprehensive and effective CMC regulatory strategies. These strategies are essential for advancing the global development of Avidity’s diverse pipeline of innovative therapies and will help ensure that we meet regulatory requirements and drive our mission forward in a fast-paced environment.
What You Will Contribute
Lead the preparation, authoring and review of CMC content for regulatory submissions (e.g., INDs, IMPDs, BLAs), ensuring high quality and adherence to program timelines. Effectively communicate and manage the integrated submission management process, from project initiation through drafting, review, data verification and content lock ensuring adherence to program goals Collaborate closely with CMC subject matter experts to identify and track appropriate source documentation to be used in the preparation of regulatory submission materials. Support the development of responses to Health Authority inquiries in a timely and effective manner. Develop standardization of document templates and technical style guide to ensure quality and consistency across programs Contribute to continuous improvement initiatives within CMC Regulatory Affairs, including SOP development, training material creation, and workflow optimization. Review technical reports and other scientific documents as required to support readiness for regulatory submissions.
What We Seek
Bachelor’s Degree (advanced degree preferred) in life sciences, engineering or chemistry, with a minimum of 10 years of experience within a biopharmaceutical company of which 5+ years must have been in CMC Regulatory Affairs and Minimum of 4 years’ experience of being part of a team, developing and managing a BLA Strong knowledge of US and international regulatory guidelines and regulations including eCTD Strong project management skills, including deep experience of SmartSheet and Veeva RIM. Self‐motivated 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 to the San Diego corporate office as needed
What We Will Provide To You
The base salary range for this role is $166,250 - $183,750. 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.
Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionLegal IndustriesInternet News Referrals increase your chances of interviewing at BioSpace by 2x Sign in to set job alerts for “Senior Manager Regulatory Affairs” roles. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr