Manager, Regulatory Affairs

Job Description

We are seeking a Manager of Regulatory Affairs to join our ITI team. The ideal candidate will have experience in development of regulatory documents for filing with the FDA (e.g., Meeting documents, INDs submissions, Annual Reports, etc.). The candidate will provide regulatory support for ITI’s development projects and regulatory documents for filing with the FDA. The candidate will also collaborate with ITI teams to deliver commitments to the organization and to patients.

Responsibilities

• Assists in the development of regulatory strategies and their execution.
• Coordinates the preparation of documents for INDs and related regulatory submissions including amendments, annual reports, new protocol submissions, protocol amendments and agency correspondence, etc.
• Identifies regulatory risks and proposes mitigations to support project team and Regulatory Affairs goals.
• Oversees the archiving and maintenance of Regulatory documents and chronologies within the document management system
• Ensures conformance to 21 CFR regulations
• Performs Regulatory Agency product approval intelligence and tracking systems.
• Contributes to process improvement.
• Supports other Regulatory activities as needed

Organizational Relationships

• Must interface face-to-face with all levels within the organization and outside vendors.

Qualifications

• B.S. Degree in Science or related field with 3 plus years of regulatory experience, Master’s a plus
• Demonstrated experience with preparing Pre-IND, IND and related non-US submissions with therapeutic biologics preferred
• Excellent written and verbal communication skills
• Solid understanding of the drug development process
• IT capability and competence with eCTD publishing systems preferred

Technical/Behavioral Skills/Competencies

• Efficient in Microsoft Word, Excel, Project, and Outlook
• Customer Focus
• Communication/Presentation Skills (spoken, written)
• Integrity/Ethics
• Initiative
• Sense of Urgency
• Teamwork
• Collaboration Skills
• Innovation

Physical Requirements

• Extended sitting and working at a computer for long periods of time.

Work Environment

• Hybrid, 3 days in the office/week

Position Type and Expected Hours of Work

• This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Please visit our careers site at http://www.immunomix.com/careers/. Send your cover letter and credentials as described on the Careers page along with the Job Code: 2024 RA003 in the subject line.

Equal Opportunity Employer

Job Type: Full-time

Pay: $140,000.00 - $160,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to Relocate:

• Rockville, MD 20850: Relocate before starting work (Required)

Work Location: In person