Director of Regulatory Affairs

Nova Pneuma, Inc.; Fremont (CA); On-site; USD 207,000 - 253,000; Full time

Job summary

Nova Pneuma, Inc. is a clinical-stage biotechnology company seeking a senior regulatory affairs leader to manage all regulatory activities and counsel R&D and commercial teams.

You will translate regulatory requirements into practical plans and coordinate with partners for submissions. This role requires IND and NDA experience, CDER/CDRH knowledge, and a proven track record leading submissions from pre-IND to approval.

Qualifications

• Experience with IND filings and regulatory submissions for clinical studies.
• IND, NDA submissions experience; NDA a plus.
• Knowledge of CDER, CDRH regulations and GMP.

Responsibilities

• Develop regulatory strategies from pre-IND through NDA submission and product approval.
• Direct regulatory activities for maintenance of commercial products.
• Coordinate regulatory submissions with the FDA and other regulatory agencies; communicate requirements to product teams.
• Collaborate with cross-functional teams to ensure regulatory compliance across filings.
• Maintain IND, NDA and other regulatory submission documents; track interactions.
• Establish and maintain regulatory SOPs and risk assessments.

Skills

FDA submissions

IND filings

NDA experience

CMC knowledge

Regulatory affairs

Partner collaboration

Education

Bachelor's degree in scientific discipline

10 to 12+ years regulatory experience

GMP regulatory environment experience

Job description

Nova Pneuma, Inc., a wholly owned subsidiary of Lee’s Pharmaceutical Holdings Limited, is a clinical-stage biotechnology company focused on developing and commercializing innovative therapies for the acute treatment of serious medical conditions—where rapid therapeutic effect can make a meaningful difference for patients.

Our team is driven by urgency, scientific rigor, and the conviction that innovation must translate into real-world benefit—simple, fast, and patient-friendly solutions that redefine how acute conditions are treated.

Job Summary

Manage all regulatory activities for the company. Work with partners representing company interests and support partner filing and regulatory activities. Provides counsel to other R&D and commercial product team members. Provides expertise in translating regulatory requirements into practical, workable plans.

Responsibilities

• Develop and implement regulatory strategies for programs that will lead to the successful submission of product candidates from pre-IND stage through the product approval process.
• Direct regulatory activities for maintenance and continued compliance of commercial product(s).
• Work with partners on their regulatory submissions, including regular meetings and document preparation for sections that the company is responsible for including data generation and reporting (mostly CMC related documents).
• Prepare and implement regulatory submissions with the FDA and other regulatory agencies and communicate regulatory requirements to product teams in a timely manner.
• Effectively coordinate work with multiple departments on data requirements and create content necessary for regulatory submissions.
• Develop sound internal policies, standards and strategies related to submissions and identify risks associated with that strategy.
• Review and approve regulatory submission documents to ensure compliance with industry and regulatory standards.
• Maintain IND, NDA, and other regulatory submission documents including tracking of all regulatory interactions.
• Establish and maintain regulatory SOPs.

Skills required

• Previous work with FDA on regulatory submissions (work with EMA is a plus).
• Must have IND filing experience and regulatory submissions related to clinical studies; as is direct regulatory experience supporting commercial products (NDA experience is a plus).
• Experience with drug safety and pharmacovigilance is a plus.
• Hands-on experience preparing domestic and international regulatory submissions, ideally both pharmaceutical and medical devices.
• Ability to work with partners in collaborative and constructive way for filings where partner is responsible for dossier.
• Solid background in pharmaceutical science and experience applying that knowledge to complex regulatory issues, including CMC, pre-clinical, and clinical aspects.
• Strong analytical, evaluation, and interpretation skills

Education and experience

• Bachelor’s degree in scientific discipline (Chemistry, Biology, biotechnology or related field) or commensurate experience; advanced degree preferred.
• 10 to 12+ years relevant senior regulatory experience in the biotechnology/pharmaceutical industry with direct regulatory affairs experience with drug products. Additional experience in medical devices a plus.
• Experience with commercial products and drug safety/pharmacovigilance is a plus.
• Solid working knowledge of all aspects of regulatory affairs from pre-IND to NDA
• Experience with GMP-regulated pharmaceuticals, medical instrumentation, or other regulated industry environment
• Expert knowledge of CDER, CDRH and other regulations

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Potentially prolonged periods standing.
• Must be able to lift up to 15 pounds at times.
• Must be willing to travel.

Compensation & EEO

The base salary for this role starts at $230,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits.

Nova Pneuma, Inc. is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.