REGULATORY AFFAIRS SPECIALIST
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Vejle
Fertin Pharma has a solid background in the Nicotine Replacement Therapy (NRT) category developing and manufacturing primarily nicotine gum. However, as part of our diversification strategy we are expanding our activities in other categories and other pharmaceutical forms. Building on our long history as a B2B company we are engaging with new customers for both European, North American and international markets in addition to progressing development opportunities by ourselves.
In order to fuel this growth along with supporting our existing customers and their mature products we are looking for an experienced regulatory affairs specialist. The position is open due to an internal relocation. You will report to Senior Manager, Regulatory & Clinical Affairs Helle Nørum.
The Regulatory Affairs function is involved in all development projects and our specialists collaborate with specialists from other departments on strategy, documentation etc. 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.
We are a small team, where individual responsibilities are mixed with collaboration across those responsibilities and we value the opportunity to discuss and strategize about regulatory approaches.
Main Responsibilities:
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. You will therefore have the possibility to work in development projects, where you will be expected to propose the best regulatory approach for the various issues that arise during a development project. You will take lead in planning and coordinating the preparation of the CMC/Quality parts of the dossier, and you will be the primary point of contact to our customer’s regulatory team. You will also handle life-cycle management activities for existing products/customers and may be also be involved in working with new customers that license some of Fertin’s own products.
You will bring your experience to bear in discussing regulatory approaches, documentation requirements and optimizing work processes.
Qualifications:
We offer:
Send your cover letter and CV as soon as possible via the link below by October 4th, 2019. Interviews will be conducted on an ongoing basis.
For further information please contact Senior Manager, Regulatory & Clinical Affairs Helle Nørum, e-mail: [email protected], phone: 7215 1324.
Ansøgningsfrist: 4. oktober 2019
Søg denne stilling: file:///C:/Users/B008528/Downloads/Application.htm
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
In order to fuel this growth along with supporting our existing customers and their mature products we are looking for an experienced regulatory affairs specialist. The position is open due to an internal relocation. You will report to Senior Manager, Regulatory & Clinical Affairs Helle Nørum.
The Regulatory Affairs function is involved in all development projects and our specialists collaborate with specialists from other departments on strategy, documentation etc. 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.
We are a small team, where individual responsibilities are mixed with collaboration across those responsibilities and we value the opportunity to discuss and strategize about regulatory approaches.
Main Responsibilities:
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. You will therefore have the possibility to work in development projects, where you will be expected to propose the best regulatory approach for the various issues that arise during a development project. You will take lead in planning and coordinating the preparation of the CMC/Quality parts of the dossier, and you will be the primary point of contact to our customer’s regulatory team. You will also handle life-cycle management activities for existing products/customers and may be also be involved in working with new customers that license some of Fertin’s own products.
You will bring your experience to bear in discussing regulatory approaches, documentation requirements and optimizing work processes.
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, alternatively from another department where you have significant experience with preparing CMC/Quality documentation for regulatory dossiers
- You are proactive, systematic and can establish and discuss a regulatory approach including risks and benefits for both life-cycle management activities as well as for issues during development
- You use your experience and knowledge to ensure that our documentation is fit for purpose with the right level of detail and compliant with authority requirements
- You have good communication skills and you are fluent in English and some knowledge in Danish.
We offer:
- An opportunity to take an important role in a small team of highly skilled colleagues
- A position where you will be able to influence the way we work and develop your competences
- An opportunity to join a leading B2B pharma company undergoing change rooted in a successful journey within nicotine chewing gum and strong aspirations to grow beyond this.
Send your cover letter and CV as soon as possible via the link below by October 4th, 2019. Interviews will be conducted on an ongoing basis.
For further information please contact Senior Manager, Regulatory & Clinical Affairs Helle Nørum, e-mail: [email protected], phone: 7215 1324.
Ansøgningsfrist: 4. oktober 2019
Søg denne stilling: file:///C:/Users/B008528/Downloads/Application.htm
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 "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Vejle.
Jobbet er oprettet på vores service den 26.9.2019, 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.
- Forsker
- Vejle
- Fredag den 04. oktober 2019
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