Senior Director, Regulatory Affairs

BioSpace; Kansas; Hybrid; USD 270,750 - 299,250; Full time

Benefits offered by this job

Stock options

Comprehensive wellness program

401(k) with employer match

Job summary

A biotechnology company is seeking a Sr. Director of Regulatory Affairs to lead global regulatory strategies and submissions. The ideal candidate has over 10 years in pharmaceutical/biotech, with substantial experience in regulatory roles. This position includes oversight of health authority interactions and management of regulatory teams, ensuring compliance and driving strategic initiatives to enhance life sciences solutions. Competitive salary and benefits offered.

Qualifications

• Minimum of 10 years of experience in pharmaceutical/biotech.
• Minimum 4-6 years in a management role within Regulatory.
• Comprehensive knowledge of relevant US and global regulations.

Responsibilities

• Serve as the global regulatory lead influencing program direction.
• Lead preparation of key Health Authority interactions.
• Ensure global regulatory applications remain inspection-ready.

Skills

Regulatory strategy development

Project management

Communication skills

Problem-solving

Leadership

Education

Bachelor's degree in Life/Health Sciences

Master's degree or Ph.D.

Job description

Profoundly Improve People’s lives by Revolutionizing the Delivery of RNA Therapeutics

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.

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).

The Opportunity

The Sr. Director, Regulatory Affairs is the Global Regulatory Affairs Lead (GRL) responsible for establishing regulatory strategies in coordination with Avidity leadership and independently developing and managing life cycle plans, as well as regulatory submissions and approvals.

What You Will Contribute

• Serve as the global regulatory lead (GRL) and thought leader on cross-functional teams, influencing program direction and development plans based on understanding of the regulatory landscape.
• Develop and communicate innovative and sound regulatory strategies that align with project objectives and overall business strategy.
• Lead preparation and execution of key Health Authority interactions (e.g., FDA, EMA, PMDA), including briefing packages, internal rehearsals, and strategy alignment.
• Lead and mentor cross-functional teams in submission planning and execution, identifying critical path activities, interdependencies, and risk mitigation strategies.
• Leverage and optimize enterprise systems (Veeva RIM, Quality, PromoMats) to drive document quality, traceability, and regulatory readiness, mentor others on system best practices.
• Ensure global regulatory applications and dossiers remain inspection-ready and in full compliance with evolving regulatory requirements.
• 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.
• Direct global clinical trial application (CTA) activities, providing advice and oversight.
• Provide oversight to Clinicaltrials.gov and global databases to enable compliance with regulatory requirements for posting protocols and results.
• Recommend and engage with external regulatory consultants and resources, including in support of challenging situations (i.e. Advisory Committees or Oral Explanation proceedings).
• Lead labeling subteam by driving cross-functional development and review of draft and final labeling content using regulatory intelligence, data, feedback and promotional objectives.
• Responsible for 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.
• Lead and support global inspection-readiness activities for programs under purview.
• Support and share global Regulatory Intelligence as new developments emerge.
• Directly supervise, mentor, and grow high-performing Regulatory Affairs professionals, fostering a culture of accountability, empowerment, and innovation.
• Work in a collaborative and highly productive environment with a focus on the advancement of regulatory objectives for the benefit of patients we serve.

What We Seek

• Bachelor's degree in Life/ Health Sciences required; Master's degree and/or Ph.D. preferred
• Minimum of 10 years of experience in pharmaceutical/biotech
• Minimum 4-6 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 a 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, 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
• Experience with the FDA Advisory Committee and EMA Oral explanation preparation and proceedings

What We Will Provide To You

• The base salary range for this role is $270,750-$299,250. 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.