Director, Regulatory Operations

San Diego, CA, United States

Job Title:

Director, Regulatory Operations

Location:

Hybrid / Remote

Position type:

FLSA:

Full time

Exempt

Department:

Regulatory Affairs

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). 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. 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 inSan 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 Twitter .

The Opportunity

We are seeking a highly experienced and motivated Director, Regulatory Operations to join our fast-paced and growing organization. This position requires an independent strategic thinker with a patient-focused mindset. This role reports to the Vice President, Regulatory Affairs and will be responsible for leading an emerging Regulatory Operations functional capability at Avidity. This individual will be responsible for management and development of one or more direct reports and for guiding and implementing new processes and systems with a view to a growing pipeline of INDs and with future additional INDs and Global Marketing Applications in the forecast.

The Director, Regulatory Operations is accountable for supporting Avidity RA objectives by supporting and managing regulatory submission-related activities and providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations. This position will work closely with Avidity RA and Medical Writing personnel as well as external vendors to build a sustainable regulatory document publishing and submissions capability at Avidity that is compliant, flexible, and fit-for-purpose.

What You Will Contribute

Management and development of one or more direct reports and responsible for guiding and supporting positive and productive growth and development of employees commensurate with their career goals and skillsets.

Collaboration with cross-functional team members and external contractors/vendors/consultants to support the planning, preparation, formatting, timely delivery of documents and submissions to support RA business priorities.

Manage and support Avidity regulatory systems including Veeva Vault Submissions and other utilities and tools used in the management of regulatory information and submission production, partnering with internal stakeholders (i.e. IT) and external vendors as appropriate

Oversight of the governance of Vault RIM such as user accounts, project dictionaries, document metadata, and organization

Responsible for publishing, submissions (including QC) and archiving of RA submissions (i.e., INDs/CTAs/BLAs/MAAs and amendments/supplements, responses to health authority requests for information, health authority briefing documents, etc.) with guidance from RA leads.

Responsible for the development, implementation, and rollout of training to the organization on Regulatory Operations processes and systems (new/existing) and training of new employees.

Interpretation and implementation of electronic regulatory submission standards, policies and operating procedure requirements and training of department as applicable.

Expert management of process and technical issues that arise during publishing or submission.

Implementation of change management in partnership with IT and QA as applicable.

Maintain current awareness of regulatory guidance, best practices, and technology advances to ensure Avidity systems and/or process projects and initiatives are compliant.

Ensure process and standards documents (e.g., SOPs, work instructions, checklists) related to document/submission publishing and regulatory systems are in place, frequently updated and coordinated with RA department priorities.

Track and manage budgets and timelines in accordance with corporate priorities and RA department commitments and objectives.

What We Seek

Bachelor’s degree in scientific and/or technical discipline. Targeting at least 8 years of regulatory operations experience within the pharmaceutical or biotech industry. Must have strong expertise in the eCTD process, oversight of electronic document management systems, and publishing software and tools. Knowledge and/or experience with Veeva eCTD publishing a plus. An equivalent combination of relevant education and experience may be considered.

At least 2 years of experience leading Regulatory Operations function with management of systems and direct reports with demonstrated success in improving and maintaining compliant systems and processes.

Expert technical skills in EDMS oversight.

Strong vendor management and project management skills.

Thorough knowledge of US and international regulations as they apply to Regulatory Operations

Knowledge of industry best practices for eCTD submissions.

Collaborative spirit to partner with Regulatory Affairs colleagues and cross-functional departments

Ability to influence and partner cross-functionally with kindness and patience

Self-organized, self-directed, and highly motivated

Strong critical thinking and analytical skills

Demonstrated ability to contribute to a continuous learning and process improvement environment

Excellent verbal and written organizational and communication skills

Skilled at negotiating with business partners and influencing management to ensure system compliance and efficiency is maintained.

What We will Provide to You:

The base salary range for this role is $211,300 - $233,500. 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

O: 858-401-7900

F: 858-401-7901

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