Fractional Senior Specialist, Regulatory Programs

Senior Specialist, Regulatory Programs (Part-Time)

Location: Alameda, CA

Type: Part-Time / Fractional / On-site

Compensation: $85 - $95 an hour

Responsibilities

• Plan, prepare, and manage submissions to HAs including, INDs, NDA/BLA regulatory filings in strong collaboration with GeneFab's clients.
• Participate in regulatory interactions with HAs including managing preparation of briefing materials for HA meetings, preparing subject matter experts (SMEs), and ensuring appropriate follow-up.
• Participate in negotiations with regulatory agencies to resolve and review issues and shepherd proactive interactions with regulators.
• Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, program teams and senior management, as relevant
• Prepare and manage GeneFab's regulatory registrations and/or licenses (e.g., FDA, Oregon Board of Pharmacy).
• Develop and implement a comprehensive quality assurance strategy aligned with the organization's goals and regulatory requirements.
• Provide strategic direction and leadership to the Quality Assurance team, fostering a culture of quality excellence and continuous improvement.
• Collaborate with cross-functional teams to integrate quality principles into all aspects of the pharmaceutical manufacturing process.
• Foster a culture of quality and compliance by promoting awareness and understanding of quality principles throughout the organization.
• Independently provide effective phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for projects.
• Work in close collaboration with clients, consultants and/or CROs, as needed, to ensure appropriate interactions with HAs.
• Manage the QA budget to ensure that resources are allocated appropriately and that all projects are completed on time and within budget.
• All other duties as assigned.

Requirements

• Minimum of a bachelor's degree, preferably in a scientific discipline.
• A minimum of 10 years of experience in compliance, quality, and CDMO/CMO management with a focus on regulatory documentation and lifecycle management.
• Minimum of 10 years of GMP/QA experience.
• General knowledge of aseptic manufacturing processes.
• Broad knowledge of FDA and international regulations related to GMPs and Biopharma.
• Experience organizing and managing work responsibilities while working independently with minimal oversight.
• Time and project management skills with the ability to multi-task and meet deadlines.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Knowledge of GMP requirements and quality regulations within the Biopharma industry, backed by extensive experience in preparing for and successfully navigating inspections conducted by global regulatory agencies, including the FDA and EMA authorities.
• Experience with drug substances and drug products is desired.
• Knowledge of regulatory requirements across development stages and post-approval is essential.
• Expert working knowledge of full drug development process and knowledge of FDA and ICH regulatory requirements.
• Strong strategic and analytical abilities, diplomacy, and negotiation skills.
• The ability to collaboratively influences multiple functions and motivates others to accomplish company objectives.
• Self-motivated and detail oriented with sound judgement and innovative thinking to deal with challenges/opportunities.