Remote-Eligible Associate Director, Regulatory Ops

Viridian Therapeutics, Inc.; United States; Hybrid; USD 163,000 - 200,000; Full time

Benefits offered by this job

Competitive pay and stock options

Comprehensive medical, dental, and vision plans

Generous vacation plan

Job summary

A biotech company is seeking an Associate Director of Regulatory Affairs Operations to manage regulatory submissions and ensure compliance with industry standards. The candidate must have at least 10 years of experience in Regulatory Operations, specifically within a Biotech or pharmaceutical setting. Expertise in tools like Veeva RIMs is essential. This role offers flexibility with the option to work remotely or from the company's Waltham, MA headquarters. Competitive benefits and a commitment to ethical standards are part of the offering.

Qualifications

• 10+ years of experience managing Regulatory Operations in a Biotech or pharmaceutical company.
• Strong project management skills in Regulatory Affairs.
• Proven strategic development capabilities related to new drug development.

Responsibilities

• Manage the end-to-end publishing of regulatory submissions.
• Coordinate with external vendors for submission-related activities.
• Proactively provide submission status updates to stakeholders.

Skills

Veeva RIMs

Regulatory Operations

Project Management

Leadership

Communication

Education

Bachelor’s degree

Tools

Microsoft Office Suite

Job description

A biotech company is seeking an Associate Director of Regulatory Affairs Operations to manage regulatory submissions and ensure compliance with industry standards. The candidate must have at least 10 years of experience in Regulatory Operations, specifically within a Biotech or pharmaceutical setting. Expertise in tools like Veeva RIMs is essential. This role offers flexibility with the option to work remotely or from the company's Waltham, MA headquarters. Competitive benefits and a commitment to ethical standards are part of the offering.