Associate Director, Regulatory Affairs CMC

Location
San Diego, California
Posted
Mar 29, 2021
Ref
oBOHefw4
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time

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)