Director, Regulatory Affairs
Company: Avidity Biosciences, Inc.
Location: San Diego
Posted on: October 28, 2024
Job Description:
Job Title:Director, Regulatory AffairsLocation:San Diego, CA /
Hybrid / RemotePosition Type:Full
timeFLSA:ExemptDepartment:Regulatory AffairsStrive to Bring a
Profound Difference to our PatientsAt 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 and .The OpportunityThe 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.
- Supervise one or more RA staff, providing mentorship and
supporting career growth opportunities.
- Provide original writing and critical evaluation of regulatory
documents, including an ability to master scientific and clinical
content related to development and regulatory objectives.
- Keep 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.
- Ensure process and standards documents (e.g., SOPs, work
instructions, checklists) related to regulatory activities and
obligations are in place and updated as needed.
- Serve 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.
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Keywords: Avidity Biosciences, Inc., San Diego , Director, Regulatory Affairs, Executive , San Diego, California
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