Senior Manager, LRBO Regulatory Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and implement FDA promotional submission activities, which include the preparation, assembly, tracking, and submission of necessary materials.

• Create submission packages and accompanying documentation related to product launches.

• Conduct independent operational quality control to ensure submission completeness, accuracy, required components, and correct document versions.

• Organize the planning, preparation, and submission of materials to OPDP for advisory review.

• Maintain records, documentation, and correspondence related to regulatory submissions.

• Develop and sustain submission checklists, templates, and reference materials.

• Identify and address operational issues related to submissions, escalating material risks or delays with suggested solutions.

• Collaborate with cross-functional teams to guarantee the timely availability of submission materials.

• Plan promotional submissions, product launches, and other urgent regulatory submissions.

• Assist in workload planning and forecasting of resources.

• Assess and enhance operational processes, focusing on standardization and automation possibilities.

• Establish and uphold business continuity and cross-training procedures.

• Contribute to technology improvements, automation, and system integration initiatives.

• Develop, maintain, and analyze operational metrics, dashboards, and reports.

• Provide operational updates and recommendations to functional leadership.

• Create and maintain procedures, work practices, operational guidance, and training materials.

• Deliver training to internal stakeholders.

• Review changes to FDA promotional submission requirements and update processes and procedures accordingly.

• Act as the primary operational contact for FDA promotional submission activities.

• Support readiness for inspections, audits, and internal assessments.

• Coordinate and direct Regulatory Operations personnel and associated resources.

• Carry out other regulatory, operations, legal, and/or corporate tasks as required.

⛳️ Requirements

• A minimum of 5 years of pertinent experience in pharmaceutical regulatory operations, particularly with FDA promotional submissions and Form FDA 2253 requirements.

• Familiarity with FDA promotional submission requirements and relevant OPDP presubmission processes.

• Capability to independently manage intricate operational activities, competing priorities, and time-sensitive deliverables.

• Experience in evaluating operational processes, identifying areas for improvement, and executing effective solutions.

• Proficiency with regulatory submissions systems, document management platforms, workflow technologies, and associated operational tools.

• Strong analytical and problem-solving abilities, including the development and interpretation of operational metrics, dashboards, and reporting.

• Excellent project management, organizational, and cross-functional coordination skills.

• Ability to exercise independent judgment, engage in proactive communication, and formulate actionable recommendations.

• Experience in leading projects, coordinating resources, and offering guidance or oversight to others.

• Strong written and verbal communication skills, particularly in interactions with senior stakeholders.

• Active Notary Public commission in the relevant jurisdiction, or the ability to obtain a commission within six months of appointment; must maintain a valid commission thereafter.

• A Bachelor's degree in a relevant field is preferred, or an equivalent mix of education, training, and relevant professional experience.

• Additional training or certification in regulatory affairs, regulatory operations, project management, or related fields is preferred.

• Paralegal certification and notary public commission are preferred.

• Ability to type/keyboard, stand, and lift/carry/pull light items (up to 10 lbs.).

• Proficient in using a computer, phone, and copier.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-funded basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching program.

• Flexible time off policy.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.

• Occasional travel may be required.