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Thread: Regulatory affairs professionals

  1. #21
    Diddums is offline Active Member
    Join Date
    Feb 2011
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    13

    Re: Regulatory affairs professionals

    1. 20k is reasonable if you have no experience but remember that this is a starting salary , after 6 months you should have experience and will be able to move to different locations and increase your salary. A manager can be earning up to 40k and this is perfectly achieveable in 5 years. Also remember that your income can be supplemented by locuming which gives you an added insight into how the products are used which other non pharmacists dont have. Regulatory affairs is not static and new regulations and issues continually arise therefore there is much scope for CPD and development. The UK pharma industry doesn't appreciate pharmacists to the same extent as other European countries however you will find that all aspects of the undergraduate degree will come in very useful. If you can speak mandarin and cantonese then don't forget to look for jobs in Chinese based companies who have an affiliate office in the UK although my understanding is that these Chinese companies mainly manufacture the active substance rather than the finished product.
    2. Regulatory affairs is a very broad title, its like saying pharmacist. Not all pharmacists do the same thing. There are RA jobs which solely focus on patient info eg labelling, leaflets and SmPCs. For medicinal products you can be working on registering the licence of a new product or maintaining it by submission of variations. This is mainly focussed on modules 1-5 of the eCTD (check google). You may be involved in the distribution of the products eg negotiating contracts or you may be involved in submitting clinical trials applications and ensuring that appropriate GCP, GMP, GDP practices are in place. You may also end up advising other departments eg marketing or medical information. Then there is regulation of medicinal devices and veterinary medicinal products which i sadly know very little about. The first and perhaps most difficult stage is to get in the door, once you are in then try to do as much as possible and get as much experience as possible.
    3. I suggest that you start off getting your foot in the door before worrying about what happens after you become the director of regulatory affairs
    4. I dont know the answer to this however my experience is that things take longer in big pharma and you have less autonomoy e.g if you want a document changed you have to go through a version control process that involves liasiing with an office in Italy who may be on strike or on a national holiday thus meaning that it can take a few weeks to change one sentence which in my mind is a very inefficient use of time. I'm sorry to say this but i would take the first job offered regardless of whether it is big pharma or an affiliate just to get into the industry and then move on from there although this obviously depends on your personal circumstances. There are very few pharmaceutical companies who have a HQ in the UK.

  2. #22
    Diddums is offline Active Member
    Join Date
    Feb 2011
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    13

    Re: Regulatory affairs professionals

    you may wish to consider starting a new thread so people can see your posts easily

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