REGULATORY AND CLINICAL AFFAIRS SPECIALIST
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Vejle
REGULATORY AND CLINICAL AFFAIRS SPECIALIST
Fertin Pharma is the world's leading B2B supplier of nicotine replacement therapy (NRT) chewing gum and specializes in developing and producing nicotine chewing gum. Furthermore, we have an expanding business both within medicated chewing gum but also within other delivery systems into both NRT and other therapeutic areas. With a unique range of product platforms and an innovative and global profile, Fertin Pharma engages in successful partnerships with leading pharmaceutical companies. Fertin Pharma is a private equity and family owned pharmaceutical company based in Vejle, Denmark.
As part of an ambitious growth plan Fertin Pharma continuously strive to improve the footprint across the world. Fertin Pharma aims to obtain market authorizations mainly in collaboration with pharmaceutical companies or as own portfolio ready for licensing. In order to fuel this growth along with supporting our existing customers and their mature products we seek an experienced regulatory and clinical affairs specialist.
The Regulatory and Clinical Affairs function is involved in strategy and documentation of all development projects. We plan, coordinate and collaborate on establishing the CMC/Quality part of the regulatory dossier and are the important link to our regulatory counterparts at our customers. We take lead in the process of responding to questions from the authorities and are an integrated part of life-cycle management activities post-approval.
The job:
Your main responsibilities will depend on your experience and interests, but you can expect it to encompass activities across all types of activities handled by the department
Qualifications:
We offer:
Send your cover letter and CV in English as soon as possible via the link below. Interviews will be conducted on an ongoing basis.
For further information please contact Senior Manager, Regulatory & Clinical Affairs Lise-Lotte Guldmann, e-mail: [email protected], phone: +45 4132 9946
Apply for this job
Fertin is a Danish contract development and manufacturing organization (CDMO) specializing in innovative intra-oral dosage formats (e.g. chewing gum, chewable tablets, among others) with nutraceutical and pharmaceutical ingredients. We provide patients and consumers with convenient, pleasurable and efficient delivery formats, based our know-how, technological capabilities and consumer insight. With development and manufacturing facilities in Denmark, Canada and India, Fertin is a private equity and family owned company based in Vejle, Denmark. Fertin has shown continuous growth over many years reaching sales upwards of US$123 million in 2018 and has more than 700 employees. For more information visit www.fertin.com.
Kilde: Jobnet.dk
Fertin Pharma is the world's leading B2B supplier of nicotine replacement therapy (NRT) chewing gum and specializes in developing and producing nicotine chewing gum. Furthermore, we have an expanding business both within medicated chewing gum but also within other delivery systems into both NRT and other therapeutic areas. With a unique range of product platforms and an innovative and global profile, Fertin Pharma engages in successful partnerships with leading pharmaceutical companies. Fertin Pharma is a private equity and family owned pharmaceutical company based in Vejle, Denmark.
As part of an ambitious growth plan Fertin Pharma continuously strive to improve the footprint across the world. Fertin Pharma aims to obtain market authorizations mainly in collaboration with pharmaceutical companies or as own portfolio ready for licensing. In order to fuel this growth along with supporting our existing customers and their mature products we seek an experienced regulatory and clinical affairs specialist.
The Regulatory and Clinical Affairs function is involved in strategy and documentation of all development projects. We plan, coordinate and collaborate on establishing the CMC/Quality part of the regulatory dossier and are the important link to our regulatory counterparts at our customers. We take lead in the process of responding to questions from the authorities and are an integrated part of life-cycle management activities post-approval.
The job:
- You will work in development projects, where you will be expected to propose the best regulatory approach
- You will plan, coordinate and collaborate on establishing the CMC/Quality part of the regulatory dossier and you are the important link to our regulatory counterparts at our customers
- You will be part of the small team responsible for planning and coordinating our clinical studies and you handle the necessary documentation related to this
- You will be responsible for Fertin Pharma’s pharmacovigilance system (the QPPV role is outsourced)
- You will work with regulatory and clinical intelligence
- You will bring your experience into discussing regulatory approaches, documentation requirements and optimizing work processes
Your main responsibilities will depend on your experience and interests, but you can expect it to encompass activities across all types of activities handled by the department
Qualifications:
- You hold a M.Sc. in pharmacy, biology or similar.
- Your will preferably have experience from a position in regulatory affairs working with the CMC/quality aspects
- You have experience with carrying out or coordinating clinical studies, ideally bioequivalence studies.
- You deliver on your tasks in a structured and dedicated manner and thrive in a fast-paced environment with many different stakeholders
- You have good communication skills and you are fluent in English.
We offer:
- An opportunity to be a part of our ambitious growth strategy focusing on both maintaining and growing the core business and to diversify our product portfolio into new categories
- A socially and academically based work environment, where we meet each other with confidence and provide you with responsibility
- Employment as soon as possible.
Send your cover letter and CV in English as soon as possible via the link below. Interviews will be conducted on an ongoing basis.
For further information please contact Senior Manager, Regulatory & Clinical Affairs Lise-Lotte Guldmann, e-mail: [email protected], phone: +45 4132 9946
Apply for this job
Fertin is a Danish contract development and manufacturing organization (CDMO) specializing in innovative intra-oral dosage formats (e.g. chewing gum, chewable tablets, among others) with nutraceutical and pharmaceutical ingredients. We provide patients and consumers with convenient, pleasurable and efficient delivery formats, based our know-how, technological capabilities and consumer insight. With development and manufacturing facilities in Denmark, Canada and India, Fertin is a private equity and family owned company based in Vejle, Denmark. Fertin has shown continuous growth over many years reaching sales upwards of US$123 million in 2018 and has more than 700 employees. For more information visit www.fertin.com.
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Vejle.
Jobbet er oprettet på vores service den 8.1.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Vejle
- Onsdag den 29. januar 2020
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