ADARx Pharmaceuticals Inc. · 4 months ago
Associate Director-Director, Regulatory Affairs
San Diego, CA, US
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
6+ years expADARx Pharmaceuticals, Inc. is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. The Associate Director / Director of Regulatory Affairs will oversee and manage all global regulatory filings and dossiers, ensuring compliance and efficiency in regulatory processes.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Accountability for managing the full life cycle of regulatory dossier preparation and submission including INDs, IMPDs, etc
Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
Coordinate across functional teams to assemble and submit responses to regulatory inquiries during dossier/application review cycles
Lead cross-functional teams to develop and to improve systems to increase efficiency of regulatory processes, including the development of Regulatory-specific SOPs
Lead and/or support regulatory submissions, consultations, and other discussions with global regulators on digital health topics, including the FDA, notified bodies, in-country representatives, distributors, and other counsels
Contribute to the preparation of research reports and presentations for internal project teams, leadership team members, and external audiences
Presentation of results in both written and oral format and delivery of completed reports within a multidisciplinary team
Promotes a team-oriented culture within and between departments
Establish and maintain excellent working relationships with critical collaborative partners throughout the company as well as external consultants as necessary
Maintain all appropriate corporate standards for office and lab safety
Other duties as assigned
Qualification
Required
Bachelor's degree or higher in a related field
Minimum 6-12 years of biotech/pharmaceutical industry
Minimum 2-5 years in a management role within Regulatory
Experience in interfacing and responding to relevant global regulatory authorities
Must have up to date understanding and knowledge of fundamental regulatory requirements for pharmaceuticals across a wide range of territories (e.g., FDA, EMA, MHRA, PMDA, ANVISA, TGA, etc.)
Ability to travel domestically and internationally (10%)
Proficiency working with Microsoft Office Suite Products, Adobe
Must be able to work independently with supervision as needed
Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment
Strong problem-solving skills and a proactive attitude towards exploring new approaches
Preferred
Master's degree and/or PhD a plus
Regulatory Affairs Certification a plus
A track-record of impacting drug development programs through driving projects to key decision points
Benefits
Equity-based compensation
Performance-based bonuses
401(k) with Company Match
Medical, Dental, Vision
Flexible Spending Account
Life Insurance
Employee Assistance Program
Employee Discounts
Gym Membership
Paid Vacation
Paid Holidays
Paid Sick, Jury Duty, Bereavement
Company
ADARx Pharmaceuticals Inc.
ADARx Pharmaceuticals, Inc., located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$332MKey Investors
LG Technology VenturesAscenta Capital
2025-02-01Series Unknown
2023-08-09Series C· $200M
2023-01-20Series B· $46M
Leadership Team
Ajim Tamboli
CFO
Robert MacLeod
Chief Scientific Officer
Recent News
2026-01-16
ADARx Pharmaceuticals
2025-12-02
ADARx Pharmaceuticals
2025-10-20
Company data provided by crunchbase