Director, Regulatory Affairs

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.

Equal Opportunity Employer


This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.