Regulatory Project Specialist
- Provide support for planning, initiating and managing delivery of projects throughout project lifecycles. Assist with effective stakeholder management and performing production tasks of the required deliverables on behalf of the department and/or requestor. Ensure all deliverables are fit for purpose by employing effective quality and project management approaches. Perform day-to-day regulatory tasks supporting Advertising and Promotion submissions to FDA, process governance, and compliance monitoring. Strong interpersonal, analytical and business acumen demonstrated through experience with negotiating, scope management, risk planning and mitigation strategies, and interaction with matrix partners. Experience monitoring planned activities to meet key project milestones. Liaise with related matrix partners including Governance, Publishing, Regulatory Reviewers, Commercial Managers, as needed, and Operations Managers to ensure seamless delivery.
Knowledge / experience in FDA Advertising and Promotion, including Pre-Clearance, submissions in eCTD format as a Regulatory requirement; Pharmaceutical promotional review and approval processes, and compliance monitoring – reporting and metrics. Strong communication (verbal and written) and interpersonal skills; strong attention to detail and the ability to prioritize projects, work independently, and interface across a multi-channeled matrix. Must be customer-focused and able to independently manage multiple priorities and demonstrate a sense of urgency for high-priority deliverables and submissions.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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