Description

Company Overview

Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.

Job Description, Associate Director, Regulatory Affairs

The Associate Director, Regulatory Affairs will provide leadership and guidance for Global Regulatory Submissions and Strategy at the Project Team level for prospective and ongoing Avidity programs. The position will be responsible for planning and executing regulatory affairs objectives in alignment with program goals (i.e. conduct of clinical trials, regulatory agency engagement, and/or submission or approval of marketing applications). The position will report to the Vice President, Regulatory Affairs. The position requires excellent communication skills (written, presentation, oral) and a demonstrated commitment to patient-focused drug development.

Primary Duties & Responsibilities:

• Provides leadership, planning and coordination of high quality regulatory deliverables to support program team objectives.
• Leads regulatory submissions with input from program team in compliance with local and regional requirements as well as within program goals and company policies (e.g. regulatory meeting requests, briefing packages, designation requests, responses to regulatory health authority requests, and IND/CTA/NDA/BLA/MAA components).
• Responsible for preparation and coordination of Development Safety Update Reports (DSURs), Investigator’s Brochures (IBs) and other documents required to maintain INDs/CTAs/NDAs/BLAs/MAAs, and other applications in good regulatory standing.
• Determines and communicates documentation requirements for submissions in a transparent and timely way to enable efficient regulatory submissions.
• Communicates and leads effectively within RA department, on cross-functional teams, and effectively directs contractors to provide high quality and on time work product.
• Serves as direct Regulatory Agency contact for applicable program(s).
• Maintains high level of aptitude with emerging global regulatory policies and requirements to enable Avidity to adapt and accelerate development plans worldwide.

• Reviews submission components to ensure compliance with health authority expectations, including associated guidelines and regulations.

• Maintains current regulatory document chronology and source files (including submissions and correspondence).
• Develops and reviews SOPs pertaining to Regulatory Affairs and associated department activities.
• Facile with document management systems, enabling identification of and efficient access to regulatory documentation across the organization.
• Participates in cross-functional team meetings for awareness of activities impacted by regulatory guidelines and expectations (new nonclinical data, protocol and clinical trial status, regional feedback or approvals, clinicaltrials.gov milestones, etc).
• Keeps RA management informed on status and timelines of pending submission components and any associated correspondence from internal team or regulatory authorities impacting development programs.
• Perform other duties as required.

Education and Job Requirements

• A/B.S. or advanced degree in scientific discipline
• At least 10 years successful work history in regulated (biotech/pharma) industry, including at least 5 years in Regulatory Affairs
• Relevant experience to support Avidity programs (e.g., rare disease, neuroscience)
• Understanding and knowledge of the format and content of regulatory submissions and/or registration documents and associated registration processes
• Ability to successfully manage complex projects and timelines in a matrix team environment, including internal and external stakeholders.
• Demonstrated interpersonal skills and Be AVID values to enable productive and successful long term relationships with colleagues.
• Maintains an attitude of continuous improvement and lifelong learning.