<div id='hrsky-content' style='margin-bottom:5px'> <h1>Specialists, Regulatory Affairs Life Cycle Management</h1><h2>- Structured specialists with strong quality focus and stakeholder management skills</h2> <p><span><span><span><span lang="EN-GB">Are you passionate about Regulatory Affairs Life Cycle Management? And do want to use all parts of your chemical - and pharmaceutical knowledge and experience in a dynamic organisation with great possibilities for professional - and personal growth? If you manage to juggle and structure various tasks in collaboration with diverse internal and external stakeholders, where you bring yourself and your knowledge into play, you may be the right match for one of these two positions.</span></span></span></span></p> <p><strong>About the job</strong></p> <p><span><span><span lang="EN-GB">We are currently looking for two</span><em><span lang="EN-GB"> Regulatory Affairs Specialists, </span></em><span lang="EN-GB">one for our</span><em><span lang="EN-GB"> Project Management and Launch team </span></em><span lang="EN-GB">and one for our</span><em><span lang="EN-GB"> CMC team</span></em><span lang="EN-GB">. These team</span><span lang="EN-GB">s are organised in <em>Regulatory Affairs Life Cycle Management</em> which holds the regulatory responsibility for our generic portfolio after the receival of the marketing authorisation. We put an honour in keeping all our marketing authorisations and dossiers up to date making sure that every product throughout all of its lifetime lives up to the current legislation. This is done in close cooperation with local Regulatory Affairs professionals throughout Europe, such as European authorities and internal colleagues from Quality, Purchase, Development, Labelling, Sales and more. </span></span></span></p> <p><span><span><span><em><span lang="EN-GB">Project Management and Launch </span></em><span lang="EN-GB">handles the more overall regulatory tasks related to the lifecycle of the products whereas </span><em><span lang="EN-US">CMC</span></em><span lang="EN-US"> focuses on our generic products produced at external partners as well as maintenance of the marketing authorization. Generally, as a</span> <span lang="EN-US">Regulatory Affairs Specialist, you will cooperate with internal and external stakeholders, such as authorities, external suppliers and colleagues from various departments. Further, you will initiate internal change controls and monitor and implement European legislation. </span></span></span></span></p> <p><span><span><span><span lang="EN-US">As a </span><span lang="EN-GB">Regulatory Affairs Specialist within </span><em><span lang="EN-GB">Project Management and Launch, s</span></em><span lang="EN-GB">ome of your main tasks will be to:</span></span></span></span></p> <ul> <li><span><span><span><span lang="EN-GB">Support launch of new products and maintain life cycle activities on our existing portfolio (quality variations, renewals, withdrawals etc.) </span></span></span></span></li> <li><span><span><span><span lang="EN-GB">Maintain and develop internal regulatory procedures as well as to maintain and implement new and existing IT systems</span></span></span></span></li> </ul> <p><span><span><span><span lang="EN-US">As a </span><span lang="EN-GB">Regulatory Affairs Specialist within </span><em><span lang="EN-GB">CMC, s</span></em><span lang="EN-GB">ome of your responsibilities will be to:</span></span></span></span></p> <ul> <li><span><span><span><span lang="EN-US">Handle module 3 variations</span></span></span></span></li> <li><span><span><span><span lang="EN-US">Review and/or author CMC documentation</span></span></span></span></li> <li><span><span><span><span lang="EN-US">Contribute to the regulatory strategy</span></span></span></span></li> <li><span><span><span><span lang="EN-US">Evaluate external change controls</span></span></span></span></li> </ul> <p><span><span><span><strong><span lang="EN-GB">Who are you?</span></strong></span></span></span></p> <p><span><span><span><span lang="EN-GB">We imagine that you are a pharmacist, Cand. Scient. or have a similar education. As you will interact with various stakeholders, you are a good communicator and are able to collaborate with all kinds of people. Additionally, you are a strong team player, but also willing and able to take responsibility and work independently. </span></span></span></span></p> <p><span><span><span><span lang="EN-GB">We expect you to be:</span></span></span></span></p> <ul> <li><span><span><span><span lang="EN-GB">Ambitious on behalf of yourself and your colleagues</span></span></span></span></li> <li><span><span><span><span lang="EN-GB"><span>Fluent in both written and verbal English</span></span></span></span></span></li> <li><span><span><span><span lang="EN-GB"><span>In possession of great analytical and coordinating skills and being able to see both the details and the bigger picture</span></span></span></span></span></li> <li><span><span><span><span lang="EN-GB"><span>In possession of a positive view on life and a good energy contributing to a good an open working environment</span></span></span></span></span></li> <li><span><span><span><span lang="EN-GB"><span>Interested and experienced within IT systems</span></span></span></span></span></li> </ul> <p><span><span><span><span lang="EN-GB"><span>Experience within pharmaceutical production and/or regulatory affairs is an advantage.</span></span></span></span></span></p> <p><span><span><span><strong><span lang="EN-GB">Who are we?</span></strong></span></span></span></p> <p><span><span><span><span lang="EN-GB">Over the past two years, Orifarm has grown rapidly growing, and lots of new tasks and challenges have arisen due to an acquisition resulting in a double size portfolio. Likewise, the organisation and processes in Regulatory Affairs Life Cycle management have developed, and these two newly established teams are a result of it.</span></span></span></span></p> <p><span><span><span><em><span lang="EN-GB">Project Management and Launch </span></em><span lang="EN-GB">is a team of seven skilled and dedicated regulatory professionals all situated in Odense. Two of the team members are, at the moment, on maternity leave. We value a casual, positive and humoristic social tone, and we make room for both laughter and seriousness. The working environment is exciting and dynamic and is characterised by everybody taking responsibility for own areas and at the same time helping each other and sparring on both a professional - and personal level. </span></span></span></span></p> <p><span><span><span><em><span lang="EN-US">CMC</span></em><span lang="EN-US"> is a team of eight skilled and dedicated regulatory professionals situated in Odense and S&oslash;borg. We value a casual, positive and humoristic social tone and we make room for both laughter and seriousness. The working environment is exciting and dynamic and is characterized by everybody taking responsibility for own areas and at the same time helping each other and sparring on both a professional - and personal level.</span></span></span></span></p> <p><span><span><span><strong><span lang="EN-GB">About Orifarm</span></strong></span></span></span></p> <p><span><span><span><span lang="EN-GB">Starting out with a strong entrepreneurial mission, Orifarm was founded in 1994 by Birgitte and Hans B&oslash;gh-S&oslash;rensen. The underlying explorer spirit still characterises the company, and with high ambition, we are constantly looking for new opportunities and business areas to invest in. Our purpose of being is to create competition and provide important savings for society and to ensure better value for money for consumers. We strive to make this happen while insisting on being good colleagues, improving together, helping each other, and innovating.</span></span></span></span></p> <p><span><span><span><span lang="EN-GB">We operate within seven business areas: Over the Counter (OTC), Consumer Healthcare, Generics, Promotional Rx, Unlicensed Medicines, Parallel import and Clinical Trials Supplies (CTS). We are the largest parallel importer of pharmaceuticals in Europe as well as the largest supplier of pharmaceuticals in Denmark. We hold a strong position in Generics in the Nordics, being the largest producer of over-the-counter medicine in Denmark. Moreover, within New Bizz, we aim to expand our business by exploring new opportunities within pharmaceuticals.</span></span></span></span></p> <p><span><span><span><strong><span lang="EN-GB">We offer</span></strong></span></span></span></p> <p><span><span><span><span lang="EN-GB">In Orifarm we place great emphasis on both your professional and personal development and on giving you the opportunity to bring all of your skills into play.</span></span></span></span></p> <p><span><span><span><span lang="EN-GB">We offer a competitive compensation and benefits package and our staff canteen offers a variety of healthy menus every day. Physiotherapy will also be at your disposal.</span></span></span></span></p> <p><span><span><span><strong><span lang="EN-GB">Job Location</span></strong></span></span></span></p> <p><span><span><span><span lang="EN-GB">It is possible for you to work from any Orifarm office and further, you have the </span><span lang="EN-US">flexibility to work partly from home as well.</span></span></span></span></p> <p><span><span><span><span lang="EN-GB"><span>If you need further information about the job, please contact VP RA Healthcare Anja Devantier via mail </span></span><a href="mailto:anjad@orifarm.com"><span lang="EN-GB"><span>anjad@orifarm.com</span></span></a><span lang="EN-GB"><span> or by phone +45 22996334.</span></span></span></span></span></p> <div class="block"> <p style="margin-bottom: 5px !important"> <strong>Application deadline:</strong> </p> As soon as possible </div> <div class='contacts' style='margin-top:20px'> </div> <script> var rollState = 'down'; window.addEventListener( 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Specialists, Regulatory Affairs Life Cycle Management

- Structured specialists with strong quality focus and stakeholder management skills

Are you passionate about Regulatory Affairs Life Cycle Management? And do want to use all parts of your chemical - and pharmaceutical knowledge and experience in a dynamic organisation with great possibilities for professional - and personal growth? If you manage to juggle and structure various tasks in collaboration with diverse internal and external stakeholders, where you bring yourself and your knowledge into play, you may be the right match for one of these two positions.

About the job

We are currently looking for two Regulatory Affairs Specialists, one for our Project Management and Launch team and one for our CMC team. These teams are organised in Regulatory Affairs Life Cycle Management which holds the regulatory responsibility for our generic portfolio after the receival of the marketing authorisation. We put an honour in keeping all our marketing authorisations and dossiers up to date making sure that every product throughout all of its lifetime lives up to the current legislation. This is done in close cooperation with local Regulatory Affairs professionals throughout Europe, such as European authorities and internal colleagues from Quality, Purchase, Development, Labelling, Sales and more.

Project Management and Launch handles the more overall regulatory tasks related to the lifecycle of the products whereas CMC focuses on our generic products produced at external partners as well as maintenance of the marketing authorization. Generally, as a Regulatory Affairs Specialist, you will cooperate with internal and external stakeholders, such as authorities, external suppliers and colleagues from various departments. Further, you will initiate internal change controls and monitor and implement European legislation.

As a Regulatory Affairs Specialist within Project Management and Launch, some of your main tasks will be to:

  • Support launch of new products and maintain life cycle activities on our existing portfolio (quality variations, renewals, withdrawals etc.)
  • Maintain and develop internal regulatory procedures as well as to maintain and implement new and existing IT systems

As a Regulatory Affairs Specialist within CMC, some of your responsibilities will be to:

  • Handle module 3 variations
  • Review and/or author CMC documentation
  • Contribute to the regulatory strategy
  • Evaluate external change controls

Who are you?

We imagine that you are a pharmacist, Cand. Scient. or have a similar education. As you will interact with various stakeholders, you are a good communicator and are able to collaborate with all kinds of people. Additionally, you are a strong team player, but also willing and able to take responsibility and work independently.

We expect you to be:

  • Ambitious on behalf of yourself and your colleagues
  • Fluent in both written and verbal English
  • In possession of great analytical and coordinating skills and being able to see both the details and the bigger picture
  • In possession of a positive view on life and a good energy contributing to a good an open working environment
  • Interested and experienced within IT systems

Experience within pharmaceutical production and/or regulatory affairs is an advantage.

Who are we?

Over the past two years, Orifarm has grown rapidly growing, and lots of new tasks and challenges have arisen due to an acquisition resulting in a double size portfolio. Likewise, the organisation and processes in Regulatory Affairs Life Cycle management have developed, and these two newly established teams are a result of it.

Project Management and Launch is a team of seven skilled and dedicated regulatory professionals all situated in Odense. Two of the team members are, at the moment, on maternity leave. We value a casual, positive and humoristic social tone, and we make room for both laughter and seriousness. The working environment is exciting and dynamic and is characterised by everybody taking responsibility for own areas and at the same time helping each other and sparring on both a professional - and personal level.

CMC is a team of eight skilled and dedicated regulatory professionals situated in Odense and Søborg. We value a casual, positive and humoristic social tone and we make room for both laughter and seriousness. The working environment is exciting and dynamic and is characterized by everybody taking responsibility for own areas and at the same time helping each other and sparring on both a professional - and personal level.

About Orifarm

Starting out with a strong entrepreneurial mission, Orifarm was founded in 1994 by Birgitte and Hans Bøgh-Sørensen. The underlying explorer spirit still characterises the company, and with high ambition, we are constantly looking for new opportunities and business areas to invest in. Our purpose of being is to create competition and provide important savings for society and to ensure better value for money for consumers. We strive to make this happen while insisting on being good colleagues, improving together, helping each other, and innovating.

We operate within seven business areas: Over the Counter (OTC), Consumer Healthcare, Generics, Promotional Rx, Unlicensed Medicines, Parallel import and Clinical Trials Supplies (CTS). We are the largest parallel importer of pharmaceuticals in Europe as well as the largest supplier of pharmaceuticals in Denmark. We hold a strong position in Generics in the Nordics, being the largest producer of over-the-counter medicine in Denmark. Moreover, within New Bizz, we aim to expand our business by exploring new opportunities within pharmaceuticals.

We offer

In Orifarm we place great emphasis on both your professional and personal development and on giving you the opportunity to bring all of your skills into play.

We offer a competitive compensation and benefits package and our staff canteen offers a variety of healthy menus every day. Physiotherapy will also be at your disposal.

Job Location

It is possible for you to work from any Orifarm office and further, you have the flexibility to work partly from home as well.

If you need further information about the job, please contact VP RA Healthcare Anja Devantier via mail anjad@orifarm.com or by phone +45 22996334.

Application deadline:

As soon as possible
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