Regulatory Lead - Oncology
GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION)
Responsible for providing global and FDA regulatory strategic guidance to clinical development teams with regard to regulatory requirements and health authority interactions. Support regulatory clinical study filings, leading and preparing teams in seeking Agency advice and maintaining compliance with reporting requirements such as DSUR, Orphan drug, PSP, annual reports, etc. Acts as Company Liaison for Health Authority interactions.
ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES)
• Development of and excellence in execution of regulatory strategy and tactics
• Effectively lead and direct interdisciplinary teams for regulatory activities
• Act as a liaison with worldwide health authorities and maintain highly effective relationships with them through exceptional written and verbal communication skills. Leads FDA meetings and fosters a positive relationship on behalf of the company
• Plans and prepares regulatory submissions for Clinical Trial Applications (CTAs)/Investigational New Drug (INDs) Applications
• Monitors due dates for all reports and regulatory commitments
• Prepares official Company responses to regulatory agency questions
• Leads in the preparation and implementation of health authority meetings.
• Interacts with Clinical Research Organizations and licensing partners regarding regulatory purposes.
• Keeps abreast of the global regulatory environment and regulations
It is each employee’s responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employee’s responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function.
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)
• Proven track record of effective collaboration with regulatory agencies and demonstrates strong knowledgeable of US and EU regulations
• Proven track record of successfully meeting regulatory milestones
• Strong leadership and influence managements skills
• Excellent communication (oral and written) skills with the demonstrated ability to work effectively with internal and external partners
• Organized with the ability to manage several complex projects simultaneously while working under pressure to meet deadlines
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL)
• Bachelor’s degree or higher in applicable discipline, with at least 10 years of related experience and/or training; or equivalent combination of education and experience.
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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