Job description

Why Work for Us

At Virogin Biotech, every day we strive to achieve incredible progress by working together to pursue our shared mission in developing novel oncolytic immunotherapies/mRNA vaccines and improving the lives of our patients. With our vision to be a global, best-in-class oncolytic virus company and with our patients’ welfare always at the top of our priorities, our teams work together to create impactful drugs for cancer patients with the hope of solving one of the world’s biggest challenges - a future without cancer.

Position Overview

The Associate Director of Regulatory Affairs will manage the Regulatory Affairs department in North America. The successful candidate will lead development and implementation of regulatory strategy and provide regulatory support for our product development plans.

Duties and Responsibilities

• Leading regulatory agency interactions, communications, and submissions, including assembly and submission of applications to competent authorities.
• Acting as the direct point of contact with FDA (and other health authorities as warranted), lead and manage FDA meetings and work with all relevant parties to successful outcomes.
• Leading and contributing to the preparation and submission of regulatory documents such as IND, Orphan Drug and Fast Track applications, BLA, Protocol Amendments, IB, DSUR, etc.). This may require working with Virogin’s global teams such as Discovery, CMC and Quality from China, Australia, and Canada.
• Identifying and interpreting regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Preparing regulatory documents for meeting requests and related packages (this will include but not limited to pre-IND, End of Phase II, Type B, and C meeting, etc.)
• Formatting regulatory dossiers with eCTD software and complete electronic submission to US FDA via ESG or secure e-mail.
• Overseeing the regulatory timeline and milestones of each project.
• Reviewing the protocols and reports from other teams (PK/toxicology CROs, clinical CROs) as necessary.
• Other duties as required.

Qualifications

• Leading regulatory agency interactions, communications, and submissions, including assembly and submission of applications to competent authorities.
• Acting as the direct point of contact with FDA (and other health authorities as warranted), lead and manage FDA meetings and work with all relevant parties to successful outcomes.
• Leading and contributing to the preparation and submission of regulatory documents such as IND, Orphan Drug and Fast Track applications, BLA, Protocol Amendments, IB, DSUR, etc.). This may require working with Virogin’s global teams such as Discovery, CMC and Quality from China, Australia, and Canada.
• Identifying and interpreting regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Preparing regulatory documents for meeting requests and related packages (this will include but not limited to pre-IND, End of Phase II, Type B, and C meeting, etc.)
• Formatting regulatory dossiers with eCTD software and complete electronic submission to US FDA via ESG or secure e-mail.
• Overseeing the regulatory timeline and milestones of each project.
• Reviewing the protocols and reports from other teams (PK/toxicology CROs, clinical CROs) as necessary.
• Other duties as required.

Join Virogin Biotech’s team of creative and motivated professionals in making a difference to solve the world’s biggest challenges—a future without cancer. For more information about our company, visit www.virogin.com

COVID-19 vaccination is an employment requirement; accommodations will be considered upon request.

Job Type: Full-time

Salary: From $160,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Education:

• Bachelor's (Required)

Experience:

• Biotechnology or Pharmaceutical Industry: 3 years (Required)
• Oncology: 1 year (Preferred)

Work Location: Remote

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