Regulatory Senior Consultant

Job Responsibilities

• Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
• Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, pre-approval submission packages, product registration applications, and post-approval maintenance.
• Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.
• Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned projects according to agreed timelines, scope of contract, budgets, and strategies.
• Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
• Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.
• Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
• Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
• Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
• Prepare training materials and share best practices in the regulatory area, both internally and externally.
• Participate as regulatory support in internal or external project audits.
• Participate as regulatory support on internal cross-functional initiatives.
• Contribute to the creation and/or maintenance of SOPs and other process related documentation as required.
• Provide support in overseeing the execution of team members’ project responsibilities.
• Capable of identifying when to ensure line support required to provide additional guidance and direction.
• Maintain individual training records (Syneos Health or client related) and complete all designated required training.

Qualification Requirements

• Master's degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field.
• Moderate pharmaceutical/medical device related experience.
• Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.
• Excellent interpersonal / communication skills including excellent written and verbal communication skills.
• Excellent customer service skills, with the ability to work both as a team member and independently.
• Good quality management skills.
• Advanced skills in Microsoft Office Applications.
• Ability to interact with staff from multiple departments and offices to establish project standards.
• Good initiative, adaptability, and pro-activity.
• Strong analytical skills, good attention to detail.
• Able to work concurrently on projects, each with specific instructions that may differ from project to project.
• Fully fluent in speaking, writing, and reading English.