Regulatory Affairs Manager

Overview

Job Summary: The Manager, Regulatory Affairs (CMC) is responsible for providing regulatory support and guidance on CMC-related to the FDA and other national regulatory authorities and will assist in the development and execution of CMC reglatory strategies and regulatory submissions for Gene and Cell Therapies and/or other biologics.

Responsibilities

Your Work:

(Roles & Responsibilities)

• Provides CMC regulatory support and guidance to project teams for clinical development and post approval changes; defines CMC regulatory submission strategies during development and post approval.
• Experienced with clinical trial (IND/IMPD/CTA) and marketing applications (BLA/NDA/MAA) filing requirements including content requirement, technical writing, and tracking timelines.
• Works with technical departments in R&D/Operations/Quality to develop high quality submissions.
• Prepares and manages submissions to filings, and supports review by regulatory authorities.
• Liaises with FDA and other regulatory authorities in written communication and participates in meetings on product development regulatory issues.
• Stays current with regulations and regulatory guidance’s.
• Responsibilties include preparing regulatory assessments of manufacturing changes, authoring department SOPs, etc.
• Effects timely and appropriate regulatory management of changes to products and/or clinical protocols for appropriate submissions.
• Prepares and/or reviews labeling, biological product deviation reporting, lot distribution reports, IND safety reports, clinical/investigator documentation, and other reports, as needed.
• May or may not manage direct reports.

Qualifications

Education Requirements:

• Bachelor’s degree in a scientific discipline or equivalent

Job Requirements:

• Typically 7 years of related experience in FDA regulated industry
• Typically 5 years of experience in regulatory affairs
• Experience with biologics required, cellular therapy experience strongly preferred
• Experience with eCTD – electronic documents and submissions
• Knowledge of cGMP/ICH/FDA regulations.
• Some travel required.

Working Conditions and Physical Requirements:

• Ability to sit or stand for extended periods of time 
• Intermittent walking to gain access to work areas
• Finger dexterity sufficient to use a computer and to complete paperwork activities
• Vision sufficient to use a computer, to read written materials and to complete paperwork activities;
• Hearing sufficient to communicate with individuals by telephone and in person
• Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
• May be required to work alternate shifts
• Ability to gown aseptically for work in Clean Room environments
• Job performed in a lab, office, or utility (noisy) environment
• Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.