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Associate Director, Regulatory Affairs CMC

Employer
Avidity Biosciences
Location
San Diego, CA, United States
Start date
Feb 17, 2021

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Discipline
Regulatory, Regulatory Affairs, Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
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Job Details

Description

Associate Director, Regulatory Affairs CMC

Position Summary

Reporting to the Sr. Vice President of Regulatory Affairs and Quality Assurance, the successful candidate will lead the CMC regulatory function and collaborate cross‐functionally to develop the CMC regulatory strategy, provide guidance to the CMC subject matter experts, and drive CMC regulatory submissions to facilitate the global development of Avidity compounds.

Key Responsibilities
  • Lead preparation, coordination, review, and maintenance of CMC content in regulatory submissions (e.g., INDs and CTAs, annual reports, Briefing Documents, NDA/MAA), to ensure timelines and corporate goals are met
  • Represent regulatory function in CMC subteam, and develop CMC regulatory strategies within that team
  • Provide regulatory CMC advice and direction, including the interpretation and application of global CMC feedback, regulations and guidance
  • Manage technical assessments of CMC source documentation and responses to technical questions on document content
  • Proactively identify potential CMC program and/or submission risks and implement appropriate regulatory mitigation strategies to support successful submissions
  • Oversee and ensure compliance with quality assurance and regulatory procedures and work practice
  • Initiate and/or contribute to process improvements which have an impact on Regulatory Affairs or other departments.
  • 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

Qualifications and Requirements
  • Bachelor's Degree, at a minimum, (advanced degree preferred) in life sciences or chemistry, with 5-8 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/NDA/MAA submissions, experience with both biologics and small molecules 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/cGMP 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)

Company

avidity banner

Our vision is to profoundly improve people’s lives by revolutionizing the delivery of RNA therapeutics. We’re utilizing our proprietary AOC platform to design, engineer, and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) with the precision of oligonucleotide-based therapies in order to redefine RNA therapeutics and more effectively target underlying genetic drivers of diseases. We are delivering on this vision by investing in our platform, our pipeline and our people.

Our commitment to rigorous and innovative science is matched only by our passion to see patients’ lives changed. We consistently challenge ourselves to Be AVID – Agile, Visionary, Integrated and Diverse.

We are assembling a diverse team experienced in rare disease and RNA therapies. Our team members bring expertise in research, development and commercial execution. We are focused on cultivating the right team to not only grow the company, but also to reflect the communities we serve. We are dedicated to employing and retaining a diverse and inclusive workforce at all levels of the organization to not only ensure that different backgrounds and perspectives are being heard and acted upon, but that our employees also feel understood, accepted and valued.

 

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avidity team 3 avidty team 2

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Company info
Website
Phone
858-401-7900
Location
10578 Science Center Drive
Suite 125
 San Diego
California
92121
US
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