Senior Specialist, Regulatory Programs (Part-Time)

The Senior Specialist, Regulatory Programs will lead quality assurance regulatory initiatives, ensuring compliance with regulatory requirements, maintaining high-quality standards, and driving continuous improvement initiatives. This key role will develop and implement regulatory strategies for successful registration and life-cycle management of complex products. The role will build and rely on critical partnerships with key stakeholders to execute strategies in alignment with business priorities.

What You Will Do

Responsibilities include planning and managing submissions to HAs, participating in regulatory interactions, negotiating with regulatory agencies, and communicating regulatory strategies to teams and senior management. The role will also develop and implement a comprehensive quality assurance strategy, provide strategic direction to the Quality Assurance team, and foster a culture of quality excellence and continuous improvement.

Why It Might Be a Fit

The ideal candidate will have a minimum of 10 years of experience in compliance, quality, and CDMO/CMO management, with a focus on regulatory documentation and lifecycle management. The candidate will have broad knowledge of FDA and international regulations related to GMPs and Biopharma, as well as experience organizing and managing work responsibilities while working independently with minimal oversight.

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.
• Broad knowledge of FDA and international regulations related to GMPs and Biopharma.
• 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.

Benefits

• Competitive hourly rate ($85 - $95 an hour)