Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs, Worldwide Regulatory Affairs
RTI International is currently seeking a Senior Regulatory Affairs Scientist with a background and interest in clinical regulatory activities as it relates to biopharmaceutical development. The primary responsibility of this position will be to provide regulatory guidance, supplemental writing, and review of clinical reports and pertinent regulatory submission sections for drugs, biologics or diagnostics development projects. This individual will fulfill a key role with a focus on clinical affairs as a member of a team of scientists in RTI’s Global Health Technologies Group working to develop new products to address critical unmet global health needs and opportunities.
Plan and oversee regulatory activities for drug development; provide expertise and strategy, to multi-functional project teams as the regulatory leader.
Provide regulatory assistance or serve as FDA regulatory contact for clients.
Write and support the preparation of regulatory documents required to support client’s global drug development and registration activities.
Serve as the primary medical writing representative on assigned product teams and closely collaborate with personnel from clinical, regulatory and scientific departments.
Manage the regulatory submission process and regulatory agency interactions with a regulatory team.
Working with a project coordinator, ensure maintenance of each product development program’s applications and documentation, per regulations.
Ensure CRO and consultant deliverables and activities are prepared or conducted on time and of high quality.
Prepare planning, strategy, summary documents, etc. for use in communicating with product developers.
Ensure compliance with GCP, GMP, and regulatory guidelines.
Initiative and independence to identify short and long-term project needs, formulate plans for satisfying those needs, and identifying resources to implement project plans.
Conduct internal (i.e., within RTI) and external business-development activities to raise the profile of Global Health Technologies’ drug development capabilities. These activities will include the preparation of proposals for submission to funding agencies.
Serve as a mentor for junior regulatory staff.
Ph.D. in a scientific or technical discipline with 6+ years' experience in biopharmaceutical drug development or clinical affairs; OR a Master's degree with 9+ years' relevant experience OR a Bachelors’ degree with 12+ years of relevant experience.
Experience with FDA interactions and/or other regulatory authorities.
Experience with clinical trials, maintaining essential documents, reviewing/writing protocols, and clinical study reports.
Excellent oral and written communications skills.
Ability to lead and work as a member of multiple project teams and achieve consensus in diverse groups.
Ability to prioritize and multi-task concurrent project demands.
To qualify, applicants must be authorized to work in the United States.
RAC certification a plus.
Internal Number: 180M8
About RTI International
RTI is an independent, nonprofit institute that provides research, development, and technical services to government and commercial clients worldwide. Our mission is to improve the human condition by turning knowledge into practice.