Our client is a biopharmaceutical company with a mission to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases.

• Overview:The Regulatory Operations Manager/Sr. Manage oversees the operational aspects of regulatory submissions and compliance, ensuring accurate, timely, and compliant preparation and submission of regulatory documents to global agencies. They also manage the regulatory infrastructure, liaise with internal and external stakeholders, and maintain current knowledge of regulations.
• Key Responsibilities:

Submission Management:

• Manage the entire submission lifecycle, from pre-planning and drafting to quality control, submission, and archiving regulatory documents.

Infrastructure Management:

• Develop and maintain the regulatory operations infrastructure, including document management systems and publishing tools.

Regulatory Knowledge:

• Stay up-to-date with regulatory requirements, guidelines, and standards, including electronic submission formats like eCTD.

Collaboration:

• Work with cross-functional teams, including regulatory affairs, research and development, and quality assurance, to ensure compliance.

Liaison:

• Communicate effectively with regulatory agencies, internal teams, and external vendors.

Project Management:

• Manage assigned projects, ensuring they are planned, coordinated, and delivered on time and within budget.

Process Improvement:

• Identify and implement process improvements to enhance efficiency and effectiveness.

Data Management:

• Utilize document management and publishing tools to ensure accuracy and completeness of regulatory submissions.

Risk Assessment:

• Perform gap analyses and risk mitigation strategies to ensure successful submission outcomes.

Skills and Qualifications:

Experience:

• Previous experience in regulatory affairs, regulatory operations, or a related field.

Knowledge:

• Deep understanding of regulatory requirements, eCTD submissions, and electronic document management systems.

Soft Skills:

• Strong communication, interpersonal, and collaboration skills.

Technical Skills:

• Proficiency in relevant software and tools, including Veeva RIM and PASS.