What are the responsibilities and job description for the Senior Director, Regulatory Operations position at Meet Life Sciences?
Director / Senior Director, Regulatory Operations
Location: Hybrid – Parsippany, NJ
Company Overview
We are partnering with a clinical and commercial-stage pharmaceutical company with marketed products and a robust pipeline. We are seeking a Director / Senior Director of Regulatory Operations to provide strategic leadership and oversight of our Regulatory Operations infrastructure, including systems, submissions, document management, and overall Regulatory Information Management needs.
Position Summary
This role will lead the Regulatory Operations function, ensuring timely, compliant, and high-quality submissions to global health authorities. The ideal candidate will be a collaborative leader with deep expertise in regulatory systems, publishing, submission management, and process optimization.
Key Responsibilities
- Provide strategic leadership for Regulatory Operations, overseeing systems, processes, submissions, and compliance.
- Lead development, validation, and maintenance of regulatory information tools and technologies.
- Ensure error-free, on-time regulatory submissions and effective document management.
- Define and implement SOPs, standards, and best practices for submissions, publishing, and archiving.
- Partner with Regulatory Leads to anticipate submission needs and mitigate risks.
- Drive continuous process improvements and oversee change management initiatives.
- Manage vendors, contractors, and cross-functional collaborations related to regulatory technologies and submissions.
- Mentor, supervise, and develop a small team of Regulatory Operations professionals.
- Stay current on emerging regulations and electronic submission standards to advise on operational impacts.
- Contribute to budget planning, resource allocation, and strategic initiatives within Regulatory Affairs.
Qualifications
- Bachelor’s degree in a scientific, analytical, or related field required; advanced degree preferred.
- 12 years of relevant experience in Regulatory Affairs/Operations within pharmaceuticals or biologics.
- Proven ability to lead and mentor a team of Regulatory Operations professionals.
- Strong knowledge of submission publishing, document management, and regulatory information systems.
- Excellent communication, organizational, and problem-solving skills.
- Demonstrated ability to balance strategic leadership with attention to operational details.
Please apply for the full job description and company details.
Salary : $205,000 - $250,000
