RA Senior Manager

$140000 - $150000 per annum
  1. Permanent
Gaithersburg, Maryland
  1. Regulatory Affairs, Operations
Posted:06/04/2021
BBBH16258

We currently have an excellent opportunity for a talented RA Senior Manager to work on a diverse and complex portfolio and execute on creative regulatory strategies. You will join an international specialty biopharmaceutical organisation on a permanent basis in the US with the flexibility to be fully remote based.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

  • You will ensure that the organisation obtains all licenses required to enable clinical trials (as needed) as well as market commercially approved products.
  • Under minimal supervision, establishing and implementing product related regulatory strategies and advising the cross-functional project teams on Regulatory considerations when developing overall strategy for assigned programs.
  • Maintaining an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to assigned programs.
  • Performing regulatory research to obtain relevant histories, precedence and other information relevant to assigned programs.
  • To oversee and lead regulatory submissions (e.g. clinical trial and marketing applications) for the organisation's drug-device combination products portfolio in compliance with applicable regulatory requirements (US and global).
  • Providing content guidance to cross functional teams for CTAs and market applications.
  • Overseeing, leading and setting strategies in place for meetings and teleconferences with regulatory agencies.
  • Under minimal supervision, identifying potential outcomes and risks associated with interactions and/or correspondence with regulatory agencies.
  • Ensuring regulatory product compliance for product (e.g. agency commitments).
  • Communicating and ensuring alignment with direct management and cross functional team.

Requirements:

  • Bachelor's degree in a life sciences or related discipline required.
  • A minimum of 10+ years of industry experience in Regulatory Affairs.
  • Must have experience interacting with FDA and other regulatory agencies.
  • Must have experience in developing and executing on advanced and complex regulatory strategies
  • Must have regulatory experience in submission of applications for small molecules and/or generics (additional combination product experience preferred) in a development or post approval setting.
  • Experience in any of the following:
    -Vaccine
    -Small molecules
    -Large molecules
    -Med device

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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