Senior Manager, Regulatory Operations

Company: Meet
Location: Stratford
Posted on: May 10, 2022

Job Description:

Senior Manager, Regulatory Operations - Oncology Focused Biotech - Fully Remote

Job Summary

My client is looking for an experienced Regulatory Operations professional working in the Biotechnology industry, to join their team as a Senior Manager of Regulatory Operations. This is a perfect opportunity for anyone looking to work for a growing and reputable Biotechnology company which provides personal and career development opportunities. If you are an outgoing and a self-motivated individual, that wants to make a difference, this is a great opportunity for you to develop your career.

Job Overview

Responsibilities:

Manage projects and collaborate with personnel from Regulatory Science and other departments to coordinate and implement high quality submission output.
Using planning tools and project management skills as required, to ensure electronic assembly of all submissions are planned, coordinated, and delivered on time to adhere to company and agency standards.
Independent in making decisions regarding your work processes and scheduling/ operational plans.
Lead negotiations with regulatory authorities during the development and review process to ensure submission approval/clearance.

Location:

Remote

Skills Required

Minimum of 4 years' experience with Regulatory Operations in a pharmaceutical/biotech company.
Previous participation in FDA regulated environment.
Knowledge of US regulatory processes preferred.
Oncology experience preferred.

Contact Details

Full job description and company details are available upon application, apply below. This position is being dealt with by Amit Sekhon at Meet, call me at 415-354-2985 or email directly at amit.sekhon@peoplewithchemistry.com to discuss further and in confidence.

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