Consultant, Global Regulatory Affairs

Cullgen Inc.; San Diego (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Cullgen Inc. in San Diego seeks a senior Regulatory Affairs Consultant to lead regulatory strategy and global operations for early- and mid-stage programs. The role includes preparing INDs/CTAs/NDAs, coordinating with the FDA, and overseeing quality functions with GMP/GCP oversight to support product advancement.

You will guide external consultants, ensure SOP updates, and ensure compliance with US and international requirements, with onsite work at the San Diego office as needed.

Qualifications

• 15+ years of industry experience in running global regulatory operations and related activities.
• Ph.D., PharmD or other relevant post-graduate level training strongly preferred.
• Excellent working knowledge of regulatory regulations, guidelines, and all phases of clinical drug development.
• Experience with Pre-IND, Pre-phase 2 and Type D meetings and responses needed.
• Ability to lead and advise under pressure, respond to complex operational challenges with innovative solutions.

Responsibilities

• Develop and implement regulatory strategy across a growing pipeline, focusing on registration of products.
• Serve as the company contact with the FDA and other regulatory authorities.
• Oversee regulatory submissions (INDs, NDAs, MAAs, CTAs) and agency meetings.
• Ensure SOPs and process documentation meet corporate, industry and regulatory standards.
• Direct internal staff and consultants to ensure R&D activities comply with US and international requirements.

Skills

Regulatory strategy

Global regulatory operations

FDA liaison

Risk management

Education

PhD/PharmD or equivalent

Tools

eCTD submissions

Job description

Position Summary:

Our ideal Consultant will bring a high level of strategic thinking paired with a get-things-done attitude, and the ability to apply their experience to manage risk and drive programs forward in a small-company environment. The successful candidate will work with the team in compiling the original submissions of IND and CTA as well as EOP2, response to Health Authority queries as well as oversight of all aspects of regulatory activities. The candidate will also oversee the quality function including working with the company’s GMP consulting firm, GCP consultants and build the quality function over time. The candidate will assure appropriate SOPs are updated and in place for the stage of development of the company.

You will support our clinical programs (Preclinical, Phase 1, 2, 3) and planned future commercial launch. This position will be an integral part of designing and advancing the company’s effort to discover, develop and commercialize our pipeline of therapeutics.

Responsibilities:

1. Develop and implement regulatory strategy across a growing pipeline of early- and mid-stage development programs, with a focus on the successful registration of these products.
   • Enable creative solutions to regulatory challenges to efficiently advance novel therapeutics to key development milestones including positioning for successful pivotal trials and registration.
   • Ensure effective risk management and communication of issues/risks across the portfolio and participate in driving prioritization of resource and spend.
   • Plan, oversee and participate in all regulatory activities, including regulatory submissions (INDs, NDAs, MAAs, CTAs etc.), preparation and leading of agency meetings.
2. Serve as the company contact with the FDA and other regulatory authorities.
3. Ensure all external data complies with required specifications, standards, protocols, SOPs and overall clinical objectives. Help ensure the continued development, review and updating of SOPs and process documentation in accordance with corporate, industry and regulatory agency standards.
4. Direct and assist internal staff and consultants, to ensure the compliance of R&D activities with U.S. and international requirements.

Requirements:

• 15+ years of industry experience in running global clinical regulatory operations and related activities in addition to successful track record as a regulatory consultant required.
• Ph.D., PharmD or other relevant post-graduate level training strongly preferred.
• Excellent working knowledge of regulatory regulations, guidelines, and all phases of clinical drug development.
• Experience with Pre-IND, Pre-phase 2 and Type D meetings and responses needed.
• Ability to lead and advise under pressure, respond to complex operational challenges with innovative solutions supported by appropriate tactics.
• Ability to occasionally work onsite from our San Diego offices.