Director, Regulatory Affairs - BioSpace : Job Details

Job TitleDirector, Regulatory AffairsLocation:San Diego, CA / Hybrid / RemoteFlsaPosition type:Full timeExemptDepartmentFinance ID:Regulatory Affairs2601-Q125-12Profoundly Improve People's lives by Revolutionizing the Delivery of RNA TherapeuticsAt 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 www.aviditybiosciences.com and engage with us on LinkedIn and X.The OpportunityThe Director of Regulatory Affairs is responsible for establishing regulatory strategies in coordination with departmental leadership and independently developing and managing life cycle plans, as well as regulatory submissions and approvals. The position is responsible for overseeing and executing global regulatory activities, including product registrations and applications (INDs, BLAs, CTAs, MAAs, Amendments, PIPs, Designations, etc.), post-approval commitments, and ensuring regulatory compliance. The position reports to the Senior Vice President, Global Regulatory Affairs and CMC Quality, and is expected to expertly and productively interface with cross-functional teams, internal senior leadership, and external consultants, and with domestic and international Regulatory Authorities. The ideal candidate for the position will preferably have experience in rare neuromuscular diseases and be passionate about developing novel therapeutics for those in need.What You Will Contribute

• Develop and communicate innovative and sound regulatory strategies that align with project objectives and overall business strategy.
• Direct and lead planning and execution of multiple simultaneous complex submissions with aptitude to understand priorities, dependencies, major objectives and critical components and timelines.
• Work easily in document management systems (i.e. Veeva RIM, Veeva Quality, Veeva PromoMats) and are willing to provide guidance to new users as required to meet objectives.
• Responsibility and experience ensuring all regulatory applications (US and Ex-US) are kept current.
• Provide original writing and critical evaluation of regulatory documents, including an ability to master scientific and clinical content for successful development and execution of regulatory objectives.
• Communicate creative ideas and manage regulatory aspects of projects in collaboration with multidisciplinary teams according to project plans and timelines.
• Proactively identify potential program and/or submission risks and implement mitigation strategies.
• Lead the coordination of meeting packages and team prep for key Regulatory Authority engagements.
• Lead global clinical trial application (CTA) activities, providing management and oversight of regulatory aspects of clinical trials.
• Plan and prepare CTAs according to local/global requirements including timelines, document development, review and submission meeting corporate objectives for trial initiation and completion.
• Provide input and oversight to Clinicaltrials.gov and global databases to enable compliance with regulatory requirements for posting protocols and results.
• Provide oversight and management of external regulatory vendors and regulatory resources
• Support labeling team by driving cross-functional development and review of draft and final labeling content using regulatory intelligence, data, feedback and promotional objectives.
• Support maintenance of approved marketing applications (e.g. annual reports, CMC supplements, labeling supplements, post-marketing commitment/requirement compliance, safety reporting)
• Review process and standards documents (e.g., SOPs, work instructions, checklists) related to regulatory activities suggest updates as needed.
• Support global inspection-readiness activities for programs under purview.
• Support and share global Regulatory Intelligence as new developments emerge.
• Ability to supervise and/or mentor one or more RA staff, providing support and career growth opportunities.
• Work in collaborative and highly productive environment with a focus on advancement of regulatory objectives for the benefit of patients we serve.

What We Seek

• Bachelor's degree Life/Health Sciences required; Master's degree and/or Ph.D. preferred
• Minimum of 8-10 years of experience in pharmaceutical / biotech
• Minimum 8 years in a management role within Regulatory
• Comprehensive knowledge of relevant US and global regulations and guidelines
• Highly skilled at planning and executing major submissions for global marketing applications.
• Proven ability to independently develop strategy and to translate it into an effective action plan
• Demonstrated success in effectively leading and collaborating productively in 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, leadership and communication skills
• Able to grasp complex technical issues and make sound decisions based on data and information from various sources
• Strong written and oral communication skills
• Experience with FDA Advisory Committee and EMA Oral explanation preparation and proceedings.

What We Will Provide To You

• The base salary range for this role is $223,250 -$246,750. 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, 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 education reimbursement program

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