Associate Director-Director, Regulatory Affairs

ADARx Pharmaceuticals Inc. • San Diego, CA

128d

About The Position

We are seeking a highly motivated and qualified individual to join our growing organization as an on-site Associate Director / Director, Regulatory Affairs and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, and highly flexible within a fast-paced environment. The Assoc. Director / Director, RA is responsible for oversight and management for all of ADARx’s global regulatory filings and dossiers.

Requirements

• 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.

Nice To Haves

• 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.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree