Associate Director, Regulatory Affairs

Job Description:

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.

Essential 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.

Essential Physical Characteristics:

Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.

On-Site Protocol:

Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

Qualifications:

• 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

Required Key Attributes:

• 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 Qualifications:

• 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.

Compensation:

• This is a full-time position, Monday-Friday, occasional overtime.
• Pay is commensurate with experience.
• 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

Work Authorization:

• United States (Required)
• Background Check

Company Overview:

ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system.

ADARx currently has multiple active programs in development with the lead candidate in the clinic.  We are well-financed by a syndicate of renowned VC firms.

ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Disclosure Statement:

• The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
• Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
• The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
• Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
• Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.