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Regulatory Affairs Manager

$neg + benefits | USA |  Regulatory Affairs, Pharmaceutical Company/Sponsor side |  Permanent  | Ref:889692

The Role

Regulatory Affairs Manager - Leading Pharma - Home Based (USA) - $neg + benefits 

This is an exciting time to join an expanding, highly successful pharma client on a permanent basis. They offer excellent training and development opportunities as well as great career progression opportunities. This role is 100% home based in the USA therefore candidates must be eligible to work in the USA.

  • Privately owned company
  • Excellent career progression opportunities
  • Great training and development
  • Exciting and innovative product range


The Company

This is an exciting time to join an expanding, highly successful leading pharma. This is a 100% home-based role based in the States and would suit someone who likes to work autonomously.

  • Global pharma specialising in dermatology and wound care
  • Exciting product range covering medicines and medical devices
  • 100% home-based role
  • Independent project work as well as group projects


The Role

The Regulatory Affairs Manager will be responsible for drug submissions to the FDA. The Regulatory Affairs Manager will ensure the submissions are completed within strict timescales and to a high standard. You will also be responsible for post marketing compliance activities.

  • Complete dossiers and manage the submissions of drug dossiers to the FDA
  • Manage post market compliance and surveillance activities
  • Work on projects independently as well as group projects



To apply for this role as a Regulatory Affairs Manager our client is hoping for someone with the following skills and experience;

  • Experienced in Regulatory Affairs, mainly submissions of medicinal products (5 years)
  • Experience submitting dossiers to the FDA
  • eCTD compilation ideally for topical / dermatological drugs
  • Good project management experience
  • Ideally dermatology experience although this isn't a pre-requisite
  • Degree educated in life sciences / pharmaceutical science


What should you do next?

This Regulatory Affairs Manager role is one not to be missed; it encompasses the opportunity to work in a fast paced environment on new and exciting products. To discuss further, please submit your current CV.

Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there. Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.



Hayley Shayestehroo

Which team and area do you work/specialise in?

I work in the Regulatory Affairs team and recruit for Regulatory Affairs professionals at all levels within Pharma, Medical Devices companies and Regulatory Consultancies

What are some of the typical roles you cover?

I cover Regulatory Affairs positions at all levels within Pharma, Medical Devices and Regulatory Consultancies, these typically include;

Regulatory Affairs Associate jobs, Regulatory Affairs Executive jobs, Regulatory Affairs Senior Associate jobs, Regulatory Affairs Manager jobs, Regulatory Affairs Senior Manager jobs, Regulatory Affairs Director jobs, Regulatory Affairs Consultant jobs, Regulatory Writer jobs and Medical Writer jobs.

What are the hot issues in your sector currently?

Within Medical Devices it is the transition from MDD to MDR in May 2020. A lot of medical device companies are hiring Regulatory professionals to prepare their company for the transition

What’s makes you #DistinctlyDifferent?

I take pride in getting to know my candidates on a personal level as well as professional. Changing jobs is a big decision for most people so I like to ensure I am placing my candidates in a role that not only matches their career aspirations but also suits their personal situation and key motivations.


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