{"id":434,"date":"2019-12-20T14:57:09","date_gmt":"2019-12-20T13:57:09","guid":{"rendered":"http:\/\/blogs.embl.org\/careers\/?p=434"},"modified":"2024-09-27T09:06:27","modified_gmt":"2024-09-27T09:06:27","slug":"vicente-tur-director-of-regulatory-affairs-at-asphalion-spain","status":"publish","type":"post","link":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/blog\/2019\/12\/vicente-tur-director-of-regulatory-affairs-at-asphalion-spain\/","title":{"rendered":"Career profile: Vicente Tur, Director of Regulatory Affairs at Asphalion, Spain"},"content":{"rendered":"\n<figure class=\"vf-figure wp-block-image  | vf-figure--align vf-figure--align-inline-end  is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1920\" height=\"2560\" class=\"vf-figure__image\" src=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-content\/uploads\/2022\/07\/2_ASPHALION_190719-edited-scaled.jpg\" alt=\"\" class=\"wp-image-1842\" style=\"width:150px;height:200px\" srcset=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-content\/uploads\/2022\/07\/2_ASPHALION_190719-edited-scaled.jpg 1920w, https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-content\/uploads\/2022\/07\/2_ASPHALION_190719-edited-225x300.jpg 225w, https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-content\/uploads\/2022\/07\/2_ASPHALION_190719-edited-768x1024.jpg 768w, https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-content\/uploads\/2022\/07\/2_ASPHALION_190719-edited-1152x1536.jpg 1152w, https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-content\/uploads\/2022\/07\/2_ASPHALION_190719-edited-1536x2048.jpg 1536w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/><\/figure>\n\n\n\n<p>Our latest career profile is Vicente Tur, Director of Regulatory Affairs at Asphalion, a scientific and regulatory consultancy with offices in Spain, Germany, the Netherlands and the United Kingdom<\/p>\n\n\n\n<p>Regulatory affairs is one of many non-research professions tightly linked with pharma and biotech industries. Roles in this area may be in-house, in the pharma industry or at consulting firms; their focus is on keeping up-to-date with industry regulations (at the national and international level), working with scientists to ensure that R&amp;D is completed and documented in a way that will enable a product to be authorised at the end of the development process \u2013 including that the active substance and finished product are manufactured with the controls required by the Regulatory Authorities. It also involves preparing and submitting administrative documentation for the regulatory authorities.<\/p>\n\n\n\n<p>In the interview, Vicente tells us more about this profession, how he moved into this area, and what he is looking for when hiring for his team.<\/p>\n\n\n\n<p>If you\u2019d like to learn more about this area, resources include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.prospects.ac.uk\/job-profiles\/regulatory-affairs-officer\">Regulatory affairs officer<\/a> \u2013 PROSPECTS Job profile<\/li>\n\n\n\n<li><a href=\"https:\/\/www.sciencemag.org\/careers\/2003\/11\/research-regulatory-affairs-long-journey-complete-life-cycle\">From Research to Regulatory Affairs: Long Journey to a Complete Life Cycle<\/a> \u2013 Science Careers<\/li>\n\n\n\n<li><a href=\"https:\/\/www.northeastern.edu\/graduate\/blog\/working-in-regulatory-affairs-careers-and-trends\/\">Working in regulatory affairs: careers and trends<\/a> \u2013 Northeastern University<\/li>\n\n\n\n<li><a href=\"http:\/\/blogs.nature.com\/naturejobs\/2015\/06\/03\/finding-job-satisfaction-in-regulatory-affairs\/\">Finding job satisfaction in regulatory affairs<\/a> \u2013 Nature Jobs<\/li>\n\n\n\n<li>Professional bodies for regulatory affairs professionals: <a href=\"https:\/\/www.topra.org\/\">TOPRA<\/a> &#8211; <a href=\"https:\/\/www.raps.org\/who-we-are\">RAPS<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>For those not familiar with the area, could you briefly summarise what regulatory affairs is? <\/strong><\/p>\n\n\n\n<p>Our work is ensuring our customers comply with all the regulations that are there, to ensure that they understand the requirements to be able to obtain the authorisation to commercialize a medicinal product in the different regulatory areas; and also the regulatory requirements of medicinal products once they are on the market. In my case, I am not working for a specific pharmaceutical company, but we are a consultancy, so in the end, we have many different types of products, projects and many different customers. We have teams specialized on medical writing, which is closer to writing a paper &#8211;&nbsp; where you are writing scientific documentation that provides the regulatory authority information on the safety and efficacy profile, and manufacturing processes for the molecule the company would like to launch as a medicine. In the regulatory affairs sector, we put together all these documents from a variety of sources. Regulatory affairs is a combination of this administrative work and also more strategic work \u2013 we also really help our customers to understand the requirements from the regulatory authorities.<\/p>\n\n\n\n<p>This information nowadays needs to be submitted to the authorities in electronic format \u2013 at the end, you have a structure which is called the electronic common technical document (eCTD). You need to organise your documentation in specific ways. You even have specifications to follow and a technical validation from the application that you submit to the different authorities. And you have a lot of things apart than the scientific and technical content of the dossier. I took advantage of my joint degree \u2013 I am a biochemist, but I was in the structural and computational biology programme at EMBL and was able to link computers to regulatory affairs: the speciality of my team is&nbsp;eSubmissions. Not everyone has the expertise to understand both sides: computational work and regulatory affairs.<\/p>\n\n\n\n<p><strong>What does your role involve?<\/strong><\/p>\n\n\n\n<p>It involves everything! Asphalion is an SME (small-medium enterprise), but we\u2019re reaching 100 people! I try to take care of everything: from training new team members, helping customers do a proper planning of their upcoming submission, meetings for strategic advice on timelines they have on mind, really helping them to understand if what they have in mind is realistic or not and making them aware of the potential hurdles that they will be having to face, so they can plan them in advance. But also internally, I\u2019m involved in many things from invoicing and internal planning, to developing new services in my team, maintaining ISO9001 quality system, meeting with customers and providers, internal meetings for strategic plans for the company for the next year, sometimes even speaking at some event or training course. Maybe in a big pharma company, the same role with the same name would be more focused \u2013 but this is what I like about being in a consultancy company. Doing a little of everything keeps the role challenging, and you\u2019re doing something new every day: anything that is needed either internally or by customers, we do it or help them to do it. If I go deeper on the subsector I am in: eSubmissions, we centralize everything that is \u201celectronic\u201d and \u201ctelematics\u201d, and nowadays the sector is going through a huge change, from the recently implemented eCTD format for paperless submissions to the regulatory authorities to the upcoming implementation of the new standard ISO IDMP to standardize the data related to medicinal products, authorities portals and databases, advanced software implementation in industry, data migration\u2026 every year there are new requirements and challenges.<\/p>\n\n\n\n<p><strong>How did you end up in this role?<\/strong><\/p>\n\n\n\n<p>I did a PhD at EMBL Heidelberg. By the time I was completing my thesis my supervisor, Luis Serrano, was moving to Barcelona to the CRG in Barcelona. I moved with him to finish some projects as a postdoc. Then I reached the point everyone gets to in science sooner or later, where you have to decide what to do next. To stay in science, the next step would be to do a second postdoc \u2013 in those days it was usual to do that in the United States. But I was really happy in Barcelona and wanted to stay there. So I moved to a local biotech, Oryzon Genomics. There I was working as a platform leader for high-throughput screening of potential molecules. That was nice \u2013 it wasn\u2019t so close to academic research, but it was still wet-lab and drug discovery. It was the beginning of the pipeline of the sector I\u2019m currently working with. It was a robotics platform \u2013 we adapt ELISA and other assays normally done in a wet lab for robots. The robots were doing these automatically. A person performing the assay can \u2013 for example \u2013 see if there is still a drop on the pipette and press again to eject it \u2013 and we had to work out how to factor these things in.<\/p>\n\n\n\n<p>That was an intermediate for me \u2013 I left academia without leaving the wet lab. Then I moved to regulatory affairs. I knew that there was this company in Barcelona, Asphalion, which at the time was quite small. I thought this might be one way to get deeper into the pharmaceutical sector and away from the wet lab. They gave me an opportunity although I was totally inexperienced in regulatory affairs, and I got a position as a technical officer.<\/p>\n\n\n\n<p><strong>And then you moved up?<\/strong><\/p>\n\n\n\n<p>Yes, basically I started as an officer and was promoted to manager then associated director and now director.<\/p>\n\n\n\n<p><strong>From your experience, would you say that it is typical for people going into regulatory affairs roles to have other industry experience first, or have you also come across people who come directly from a postdoc or PhD?<\/strong><\/p>\n\n\n\n<p>I think I\u2019ve seen all possibilities. It also depends on the specific subsector. For example, medical writing \u2013 which is basically, if you allow me a simple comparison, like writing a big scientific paper \u2013 is more similar to the work in academia, so it\u2019s easier for scientists to do a transition into this area. For regulatory affairs, you need to read a lot of EC regulations, technical guidance, so there is very little in common with the jobs I was doing previously. There are lots of different ways to go into industry.<\/p>\n\n\n\n<p><strong>What have you found most challenging about working in regulatory affairs?<\/strong><\/p>\n\n\n\n<p>The answer is crystal clear for me \u2013 especially working in a consultancy: the answer is timelines. When you are doing a PhD or postdoc your timeline is years \u2013 you have funding, for example, from Horizon 2020 and you have three to four years to do your project. Even writing a paper is a timeline of months. In consultancy for the pharmaceutical industry the speed is very different \u2013 we have projects for months or weeks \u2013 sometimes even days, and we have many different customers with different needs.<\/p>\n\n\n\n<p><strong>Do those timelines impact your work-life balance?<\/strong><\/p>\n\n\n\n<p>Industry is very absorbing, but it\u2019s the same in academia. At least in my case, I can say my employer takes really care of us. There will be times when you have a work peak, and you need to solve the needs of your client almost immediately. But if you are working a lot on a project, this is compensated \u2013 for example, you might be able to take additional time off. Of course, this depends on the company \u2013 but many already know that the happier you are the happier your customer will be. So it is tough, but it is compensated, at the end the answer is flexibility.<\/p>\n\n\n\n<p><strong>What is the most enjoyable about working in this area?<\/strong><\/p>\n\n\n\n<p>One of the things I like the most is that it is never boring. I would say that this applies not only to the field of regulatory affairs but also as it is a consultancy. At the end, you will always have clients with new needs, there are always new regulations. You need to be adaptive. On one side this could be seen as a challenging, but it also what make the work exciting and so that you don\u2019t get bored doing the same thing after a couple of years.<\/p>\n\n\n\n<p><strong>What skills and character traits do you think were needed for you, and others, to be successful in regulatory affairs roles?<\/strong><\/p>\n\n\n\n<p>When I was doing the interview for this position, I really had to sell myself. You don\u2019t have experience, but you already have the skills of working in an international environment, which is really a key plus. You have the ability to understand and learn new things \u2013 the regulation is public and available, you\u2019ll need the experience to get more familiar but it\u2019s only a matter of time. The skill of knowing where to find information is also needed for a PhD. Also, the skills of project management you also get in academia \u2013 visualise a project, draft how to start the project, evaluate the risks and opportunities of the field. With the exception of the technical knowledge, which you will learn with time, you really have the skills from a PhD or postdoc. Not everyone is aware of these non-technical skills they have. Communication is another one \u2013 being able to communicate to people and adapt this to who you are to talking to.<\/p>\n\n\n\n<p><strong>Is there anything else you look for in an application?<\/strong><\/p>\n\n\n\n<p>Of course, experience in the sector is interesting \u2013 but people can start in a junior position without this. What I am looking for is experience in an international environment \u2013 this is important. Another thing I really like is people who are proactive \u2013 who proactively read guidance and are eager to learn new things and adapt quickly. Every year in this sector there are new guidances, regulations and challenges. So even if you know everything, in some years your knowledge could be obsolete. You need continuous learning. Having a PhD could even be a plus \u2013 it shows that you are not scared of learning and adapting and reinventing yourself every year. In this specific case, as we work with electronic formats and specifications, liking computers is also a plus.<\/p>\n\n\n\n<p><strong>In what ways is the work you are doing similar to the work you did in academia and in what ways&nbsp;different?<\/strong><\/p>\n\n\n\n<p>From a technical point of view, my work has nothing to do with what I did in academia. But from a strategic point of view it\u2019s not that different: at the end of the day, everything is about projects and timelines, about being&nbsp; able to write a realistic project plan and allocate resources properly. It\u2019s complicated to answer this question \u2013 but I believe I wouldn\u2019t have been here if I didn\u2019t have a PhD and postdoc beforehand..<\/p>\n\n\n\n<p><strong>The office you work in is in Spain, but <em>Asphalion<\/em><\/strong><strong> is international. Is the working language Spanish or English?<\/strong><\/p>\n\n\n\n<p>It\u2019s English. This is one thing I love about my team. We have people from everywhere \u2013 of course, we have Spanish people in the team, but my team manager is Czech and we have officers who are British and Italian. It\u2019s a really international environment and we have customers all over the globe.<\/p>\n\n\n\n<p><strong>Is there anything else you think important to mention, that we haven\u2019t covered?<\/strong><\/p>\n\n\n\n<p>I\u2019ve been quite active in a number of forums providing advice to PhDs and postdocs, like ENABLE or PRBB career chats. What I see is they sometimes get really discouraged, because everything gets reduced to a matter of experience in Industry \u2013 so they might hear \u201cyou don\u2019t have experience and you\u2019re already 30-something or 40-something\u201d, and opportunities also don\u2019t come up that often. But you will always find someone who will give you a chance to show what you can do. The only thing they lack is the technical knowledge, which they can acquire in a couple of years. I\u2019d advise not to get frustrated if you have a few HR interviews and are discarded. It happens, you just need to be persistent \u2013 and prove that you have the interest in this, and that you can learn \/ adapt quickly. This is something a PhD gives you: you have a plan, but you have to adapt as your first experiment generally doesn\u2019t work and you need a different approach. Even if you need to start in a junior position, that will be a transition while you learn the new sector and then you\u2019ll be able to go further.<\/p>\n\n\n\n<p><strong>You mentioned earlier that not everyone is aware of these non-technical skills they have. In the EMBL Fellows\u2019 Career Service, we also see that once those skills are recognised, it can take a bit of practice to really communicate those skills well. Is that also your experience?<\/strong><\/p>\n\n\n\n<p>Exactly, it\u2019s about communicating these skills properly, both in terms of CV and personal interview. It probably takes 2-3 interviews until you reach a point where you understand how you should be communicating. Luckily there are more and more resources available for this nowadays.<\/p>\n\n\n<hr class=\"vf-divider\">\n\n\n<p>You can find Vicente on LinkedIn <a href=\"https:\/\/www.linkedin.com\/in\/vicentetur?lipi=urn%3Ali%3Apage%3Ad_flagship3_profile_view_base_contact_details%3BapPJCMIXShW7ahmHadpQVQ%3D%3D\">here<\/a>.<\/p>\n\n\n\n<p>EMBL fellows and staff who would like to contact Vicente should contact the <a href=\"https:\/\/www.embl.org\/internal-information\/eicat\/embl-fellows-career-service\/#members\">EMBL Fellows&#8217; Career Service<\/a>, who can put you in touch with him. EMBL personnel can also contact other alumni working in similar roles via the <a href=\"https:\/\/www.embl.org\/about\/info\/alumni\/community\/directory\/\">EMBL alumni directory<\/a>. This can be used to seek career advice \/ informal mentoring<a href=\"https:\/\/intranet.embl.de\/alumni\/alumni-directory\/index.html\">. <\/a>Please see our article on <a href=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/blog\/2018\/10\/informational-interviews\/\">informational interviews<\/a><a href=\"https:\/\/blogs.embl.org\/careers\/informational-interviews\/\"> <\/a>for ideas on how to make the most of such opportunities.<\/p>\n\n\n\n<article class=\"vf-card vf-card--brand vf-card--striped vf-u-margin__bottom--800\" default>\n  \n  <div class=\"vf-card__content | vf-stack vf-stack--400\">\n          <h3 class=\"vf-card__heading\">\n                  <a class=\"vf-card__link\" href=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/info-resources\/exploration\/regulatory-affairs-quality-and-safety\/\" target=\"\">\n        \n        Additional resources on our webpages\n                  <svg aria-hidden=\"true\" class=\"vf-card__heading__icon | vf-icon vf-icon-arrow--inline-end\" width=\"1em\" height=\"1em\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n            <path d=\"M0 12c0 6.627 5.373 12 12 12s12-5.373 12-12S18.627 0 12 0C5.376.008.008 5.376 0 12zm13.707-5.209l4.5 4.5a1 1 0 010 1.414l-4.5 4.5a1 1 0 01-1.414-1.414l2.366-2.367a.25.25 0 00-.177-.424H6a1 1 0 010-2h8.482a.25.25 0 00.177-.427l-2.366-2.368a1 1 0 011.414-1.414z\" fill=\"currentColor\" fill-rule=\"nonzero\"><\/path>\n          <\/svg>\n        <\/a>\n              <\/h3>\n    \n    \n          <p class=\"vf-card__text\">Our career information page &#8216;regulatory affairs&#8217; includes further links and resources related to this career area.<\/p>\n      <\/div>\n<\/article>\n","protected":false},"excerpt":{"rendered":"<p>Vicente Tur tells us about his career in regulatory affairs, one of many non-research professions tightly linked with pharma and biotech industries.<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[3332,3364],"tags":[3392,3406,3420,3446,3462],"embl_taxonomy":[],"class_list":["post-434","post","type-post","status-publish","format-standard","hentry","category-career-profiles","category-regulation","tag-career-change","tag-computational","tag-embl-alumni","tag-non-academic-options","tag-strategy"],"acf":[],"embl_taxonomy_terms":[],"featured_image_src":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-includes\/images\/media\/default.svg","_links":{"self":[{"href":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-json\/wp\/v2\/posts\/434","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-json\/wp\/v2\/comments?post=434"}],"version-history":[{"count":12,"href":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-json\/wp\/v2\/posts\/434\/revisions"}],"predecessor-version":[{"id":19657,"href":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-json\/wp\/v2\/posts\/434\/revisions\/19657"}],"wp:attachment":[{"href":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-json\/wp\/v2\/media?parent=434"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-json\/wp\/v2\/categories?post=434"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-json\/wp\/v2\/tags?post=434"},{"taxonomy":"embl_taxonomy","embeddable":true,"href":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-json\/wp\/v2\/embl_taxonomy?post=434"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}