Regulatory Project Managers/Management ** Rare Diseases & Multiple Modalities ** Global Role for exciting indications ** Remote

Reference: TM10595A

Expiry Date: 17-08-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

San Francisco County
United States
Remote Working

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Job Description

Location: Offices on the East Coast and West Coast, but this role can also be remote.

My client is a growing company, with a great reputation within the industry for innovation and creatively in how they bring new medicines to market.  They are actively recruiting for professional Regulatory Project Managers at Senior Manager &/or Associate Director grades to manage projects and support the execution of regulatory strategies within the Global Regulatory Affairs function for an exciting portfolio of products.

As the Regulatory Project Manager, you will manage Regulatory subteams and subteam meetings and work with Global Regulatory Leads (GRL) to execute upon regulatory strategies.  You will be asked to translate global regulatory strategies into meaningful, executable submission plans, applying your project management expertise to assist my client in driving their pipeline of rare disease programs into the hands of patients. 

You’ll be working on an exciting portfolio across broad therapeutic areas and modalities in both early and late-stage development programs as well as marketed products, with plenty of opportunities to broaden your experience and advance your career.

This is a global role, that is varied, allowing you to work across all stages of the lifecycle and includes activities such as identifying risks and mitigation strategies, developing and maintaining portfolio level reports, tracking functional submission milestones, and assuring that regulatory timelines are aligned with global program strategies.

Ideal/interested candidates will have:

  • Bachelor’s or higher degree
  • Experience in regulatory project management
  • Working knowledge of development and global regulatory agency regulations, guidelines, and submissions
  • Direct experience managing original Marketing Applications and/or LCM submissions
  • Energy and enthusiasm to solve problems and build consensus
  • Evidence of strategic thinking with a focus on regulatory strategy execution and global process improvement and

On offer is a very competitive package including a high-end basic salary, bonus of 20% and a generous LTi package worth potentially an additional 30-40% of your yearly basic salary. Healthcare and insurances are all fully comprehensive and my client offers a flexible working with the option to be fully remote with occasional travel to their offices.


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, on US 908-348-6714. I will support you throughout the interview and on-boarding experience.

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