Director, Regulatory Affairs

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Job description

Job Title:

Director, Regulatory Affairs

Location:

San Diego, CA / Hybrid / Remote

Position type:

FLSA:

Full time

Exempt

Department:

Finance ID:

Regulatory Affairs

8300-Q224-2

Strive to Bring a Profound Difference to our Patients 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 and engage with us on LinkedIn and Twitter .

The Opportunity

The Director, Regulatory Affairs is responsible for establishing regulatory strategies in coordination with departmental leadership, and independently developing and 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 expertly and productively interface with cross-functional teams, with internal senior leadership and external consultants, and with domestic and international Regulatory Authorities. The optimal candidate for the position will preferably have experience in rare neuromuscular disease and be passionate about developing novel therapeutics for people in need.

What You Will Contribute

• Establish regulatory strategies and plans by collaborating and coordinating with relevant development team members - represent the regulatory function as a core development team contributor
• Supervises one or more RA staff, providing mentorship and supporting career growth opportunities.
• Provides original writing and critical evaluation of regulatory documents, including an ability to master scientific and clinical content related to development and regulatory objectives.
• 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.
• 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 lead 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
• Facile with document management systems (i.e. Veeva) and willing to provide guidance to new users as required to meet objectives.
• Ensures process and standards documents (e.g., SOPs, work instructions, checklists) related to regulatory activities and obligations are in place and updated as needed.
• Serves as SME for RA in inspection-readiness activities for programs under purview.
• Develop Avidity Regulatory Intelligence as new developments emerge.
• 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

What We Seek

• 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

What We will Provide to You:

• The base salary range for this role is $211,000-$288,900. 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.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA

92121

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