Regulatory Affairs Manager

Clinical Dynamix, Inc.; Bridgewater Township (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

Clinical Dynamix, Inc. seeks a Regulatory Affairs Manager to lead regulatory strategy and submissions for US and Canada. You will interface with health authorities and manage lifecycle activities to ensure compliance.

The ideal candidate has 5+ years in regulatory affairs, experience in a commercial-stage company, and strong project management in a fast-paced setting, with PV/regulatory collaboration as a plus.

Qualifications

• Bachelor’s degree required; life sciences advanced degree preferred.
• At least 5 years of regulatory affairs experience.
• Experience in a commercial-stage organization.
• Ability to deliver quality results in a fast-paced environment.

Responsibilities

• Develop and implement regulatory strategies for US and Canada.
• Prepare regulatory submissions and lifecycle management.
• Coordinate with FDA and Health Canada for drug development.
• Review documentation for IND submissions and lifecycle changes.
• Oversee submissions of advertising material to FDA as required.
• Maintain product labeling in compliance with regulations.
• Track PSURs and annual reports; ensure timely submissions.
• Collaborate with Medical Affairs & Pharmacovigilance on safety reporting.
• Ensure compliance with post-marketing reporting obligations.

Skills

Regulatory strategy

Regulatory submissions

Project management

FDA regulations

Pharmacovigilance

Education

Bachelor's degree

Advanced life sciences degree

Tools

Veeva platform

Job description

Regulatory Affairs Manager Job Description

Overview

• Manage Company’s Regulatory Affairs for assigned products for US and Canada, including implementation of the overall regulatory strategy, preparation of regulatory submissions and interface with relevant health authorities.

Essential Duties and Responsibilities

• Implement regulatory strategies supporting drug development and lifecycle management for US and Canada.
• Review documentation and prepare lifecycle management submissions.
• Review documentation and prepare drug development activity of pre-IND and IND submissions.
• Liaise with regulatory authorities as needed pertaining to drug development and product lifecycle management.
• Oversee submission of advertising and promotional material to the FDA as required.
• Support the labeling and/or change control processes to ensure timely and comprehensive review.
• Maintain labels/labeling for newly acquired and existing products in compliance with regulatory requirements and company standards.
• Track Annual Report and Periodic Safety Update Reports (PSUR) schedules to ensure that required dossiers are prepared and submitted as required.
• Coordinate with Medical Affairs & Pharmacovigilance to ensure timely reporting of safety data to regulatory agencies and partners.
• Ensure compliance with all federal regulations regarding post-marketing reporting to the FDA and other health authorities.
• Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities.
• Perform additional duties as may be assigned.

Education and Experience

• Bachelor’s degree required; advanced degree in the life sciences preferred.
• A minimum of 5 years’ experience in Regulatory Affairs
• Experience in a commercial-stage organization required.
• Demonstrated ability to deliver quality results within a fast-paced, dynamic environment.

Knowledge and Skills

• Knowledge of current FDA and Health Canada regulations and guidance; and knowledge of and experience with pharmacovigilance and related drug safety reporting regulations.
• Ability to manage multiple priorities and regulatory submissions at different stages as required.
• Strong project management skills with proven ability to drive projects through to completion.
• Working knowledge of Veeva platform helpful but not required.