Senior Manager/Associate Director Of Regulatory Affairs

Overview

• Lead regulatory strategies for domestic and international drug registrations, ensuring compliance with governmental regulations and guidelines.
• Develop and implement regulatory pathways for proprietary and combination drug products during development and post-approval phases.
• Collaborate with cross-functional teams to align regulatory strategies with business objectives and therapeutic area expertise.
• Provide leadership and mentorship to regulatory affairs personnel, fostering professional growth and project success.
• Ensure effective communication with domestic and international regulatory agencies to achieve desired outcomes.
• Maintain expertise in FDA interactions, IND submissions, and 505(b)(2) pathways.
• Utilize advanced knowledge of CFR, ICH guidelines, and electronic submission requirements.
• Contribute to the development of regulatory documentation and inter-departmental coordination.

Key Responsibilities & Duties

• Develop and direct regulatory strategies for nonclinical and clinical drug development and FDA submissions.
• Ensure compliance with domestic and international regulatory requirements and guidelines.
• Collaborate with internal and external teams to align regulatory actions with organizational goals.
• Manage and mentor regulatory affairs personnel, fostering a collaborative and efficient work environment.
• Coordinate inter-departmental personnel and documentation to support regulatory submissions.
• Interact effectively with regulatory agencies to achieve successful outcomes for drug approvals.
• Utilize expertise in therapeutic areas such as oncology or neurology to inform regulatory strategies.
• Leverage proficiency in electronic submission requirements and database management tools.

Job Requirements

• Master’s degree or higher in a scientific field; RAC certification desirable.
• 7-12 years of experience in regulatory affairs, including FDA interactions.
• Expertise in therapeutic areas such as oncology or neurology.
• Proven experience with IND submissions and 505(b)(2) pathways.
• Proficiency in Microsoft Windows, Adobe Acrobat, and database management tools.
• Strong organizational and facilitation skills for coordinating inter-departmental personnel and documentation.
• Excellent written and verbal communication skills for effective interaction with regulatory agencies.
• Ability to work independently and collaboratively in a fast-paced, matrixed environment.