Company Overview

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

Position Overview

The Director, Regulatory Affairs is responsible for establishing regulatory strategies in coordination with departmental leadership, and independently managing life cycle plans along with regulatory submissions and approvals. The position is responsible for oversight and execution of global regulatory activities, for product registrations and applications (INDs, BLAs, CTAs, MAAs, Amendments, PIPs, Designations, etc.) and regulatory compliance. The position is expected to capably interface with internal senior leadership and external consultants as well as with domestic and international Regulatory Authorities. The optimal candidate for the position will be passionate about developing novel therapeutics for people in need.

Responsibilities

• Establish regulatory strategies and plans by collaborating and coordinating with relevant development team members - represent the regulatory function as a core development team contributor
• Communicate creative ideas and manage regulatory aspects of projects in collaboration with multidisciplinary teams according to project plans and timelines
• Develop and communicate regulatory strategies and plans that align with project objectives and overall business strategy
• Direct and lead execution plans for regulatory submissions
• Proactively identify potential program and/or submission risks and implement appropriate regulatory mitigation strategies to support successful outcomes
• Lead the coordination of regulatory meeting packages and contribute to Regulatory Authority meetings
• Assist in the management and oversight of regulatory activities relating to clinical trials
• Assist with leadership of the regulatory team and use experience and expertise to provide guidance to the wider organization
• Provide oversight and management of external regulatory vendors and regulatory resources
• Advise on labeling, promotional review and other post marketing/commercial regulatory activities
• Assure compliance with regulatory reporting requirements
• Initiate and/or contribute to process improvements which have an impact on Regulatory Affairs or other departments.
• Represent the Company’s interests with national government agencies, industry associations and/or other organizations with legislation, regulations and/or guidelines that impact the business
• Perform other duties as required

Qualifications

• Bachelor’s Degree required; Advanced Degree preferred
• Bachelor’s degree Life/Health Sciences; Master’s degree and/or Ph.D. a plus
• Minimum of 8-10 years of experience in pharmaceutical / biotech
• Minimum 4-6 years in a management role within Regulatory
• Comprehensive knowledge of current US and ex-US regulations and guidelines, in-depth experience leading Regulatory in Global environments, including development of strategies and assessment of risks related to regulatory and development activities
• Experience developing products, including INDs, CTAs, NDAs/BLAs, MAAs, expedited approval pathways, etc.
• Proven ability to establish strategy and to translate it into an effective, long term action plan
• Demonstrated success in effectively leading regulatory teams
• Thorough understanding of the regulatory process from development through commercialization
• Strong project management skills
• Established track record with evidence of excellent problem solving, collaborative, leadership, and communication skills
• Strong written and oral communication skills
• Able to grasp complex technical issues and make sound decisions based on data and information from various sources
• Ability to foster and promote internal collaboration