Regulatory Affairs Specialist

Qnovia, Inc.; Newport Beach (CA); Hybrid; USD 120,000 - 155,000; Full time

Benefits offered by this job

Comprehensive medical, dental, and vision insurance

Equity ownership in a pre-commercial stage company

Flexible hybrid work arrangement

401(k) with company match

Job summary

Qnovia, Inc. in Newport Beach is seeking a Regulatory Affairs Specialist to lead regulatory strategy for drug-device combination products. You will develop and execute regulatory strategies, prepare submissions, and liaise with regulatory agencies such as the FDA and MHRA.

The ideal candidate has 5+ years of experience in regulatory affairs, a Bachelor's degree in a related field, and strong technical writing skills. Compensation ranges from $120,000 to $155,000 annually, including equity participation.

We offer comprehensive medical insurance and a flexible hybrid work arrangement.

Qualifications

• 5+ years of regulatory affairs experience in the pharmaceutical or medical device industry.
• Direct experience with FDA CDER and/or CDRH submission processes.
• Knowledge of 21 CFR Parts 210, 211, 314, 812, and 820.

Responsibilities

• Develop and execute regulatory strategies for drug-device combination products.
• Prepare and manage IND, NDA, 505(b)(2), and MAA submissions.
• Author and review regulatory documents including briefing packages.

Skills

Regulatory affairs experience

Technical writing and document management

Knowledge of FDA CDER processes

Knowledge of CDRH submission processes

Experience with combination product pathways

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Job description

Lead regulatory strategy and submission activities for Qnovia's drug-device combination products across FDA, MHRA, and other global regulatory bodies.

About the Role

Qnovia is advancing a portfolio of drug-device combination products through regulatory pathways in the United States and United Kingdom. As a Regulatory Affairs Specialist, you will develop and execute regulatory strategies, prepare submission documents, and serve as the primary liaison with regulatory agencies. This role requires deep knowledge of CDER and CDRH requirements for combination products.

Responsibilities

• Develop and execute regulatory strategies for drug-device combination products
• Prepare and manage IND, NDA, 505(b)(2), and MAA submissions
• Author and review regulatory documents including briefing packages, meeting requests, and agency correspondence
• Monitor and interpret evolving regulatory requirements and guidance documents
• Support pre-submission meetings and formal interactions with FDA and MHRA
• Collaborate with clinical, quality, and R&D teams to ensure regulatory compliance throughout product development
• Maintain regulatory intelligence on combination product pathways and competitive landscape
• Contribute to labeling development and promotional review activities

Qualifications

• Bachelor's degree in life sciences, pharmacy, engineering, or related field; advanced degree preferred
• 5+ years of regulatory affairs experience in the pharmaceutical or medical device industry
• Direct experience with FDA CDER and/or CDRH submission processesKnowledge of 21 CFR Parts 210, 211, 314, 812, and 820
• Experience with combination product regulatory pathways (21 CFR Part 3)
• Strong technical writing and document management skills

Preferred Qualifications

• Experience with inhaled drug products or respiratory drug delivery
• Background in UK MHRA or EMA regulatory submissions
• Experience with breakthrough therapy or fast-track designation processes
• Familiarity with eCTD submission format and publishing tools

$120,000 - $155,000 annually, depending on experience. Equity participation included.

• Comprehensive medical, dental, and vision insurance
• Equity ownership in a pre-commercial stage company
• Flexible hybrid work arrangement
• 401(k) with company match

Qnovia, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by applicable federal, state, or local law.

If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please contact us at [e-mail].

This job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Qnovia reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.