Regulatory CMS Senior Manager

Overview

Remote
$50 - $60
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 11 Month(s)
Able to Provide Sponsorship

Skills

Business Analysis
Collaboration
NDA
Management
High Availability
Regulatory Affairs
Business Analytics
Pharmaceutical Industry
Communication
Crystal Management Console
Problem Solving
Project Management
Evaluation
Conflict Resolution
Veeva
Supervision

Job Details

C2C Role

Please share Profiles at

Hi,

Urgent need,

Job Title: Regulatory Studio CMS Senior Manager

Work location: New Brunswick (preferred), Lawrenceville

Monday thru Friday - Normal business hours, with some flexibility

50% onsite - Team is onsite Monday thru Thursday

Top 3 to 5 skills/Must Haves:

Small Molecule Drug development experience (2 to 3 years)

Good communications skills (written/verbal)

Experience with Veeva System

PREREQUISITES BS/BA degree in Scientific Discipline (master's or higher preferred) with

5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred.

Responsibilities will include, but are not limited to, the following:

  1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries.
  2. Prepare and review CMC submission documents, registration dossiers, and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
  3. May be responsible for the global regulatory evaluation of CMC change controls with supervision.
  4. Work with CMC cross-functional teams and Regulatory Affairs teams.
  5. Develop and maintain knowledge of regulatory environment, regulations and procedures.

Skills/Knowledge Required:

- Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations)

- Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations

- Experience in post-approval requirements

- Experience in developing CMC regulatory strategy

- Experience in project management

- Have a solution-oriented approach to problem solving

- Ability to plan/prioritize work of group members and guide/develop others.

- Ability to work on complex projects and within cross-functional teams with supervision

- Excellent communication skills, both written and oral

- Excellent computer skills

The highlights are as below:

- Experience with Veeva System, documentam is must for the candidates

- Small Molecule (marketed products) Drug development experience (2 to 3 years)

- Expert in post approval submissions globally (mainly amendments for FDA, variations EU)

- Able to answer HA questions directly, direct coordination with HAs

- Exp in initial submission for MAA, NDA/IND/ANDAs will be brownie points

Comments for Suppliers:

Thanks and regards

Shaik Wazeed

Sureminds Solutions

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