Global Regulatory Affairs Managers
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Kongens Lyngby
PharmaRelations are supporting Ferring, an innovative and fast growing company in recruiting of 2 Global Regulatory Affairs Managers, preferably senior profiles to join their Regulatory team in Ørestaden, Copenhagen. Both positions are office based with flexibility to work from home, and both are full time.
The 2 positions are in 2 different CMC teams: one in Gastro&Urology and one in Reproductive Medicines and Maternal Health. For the position in Gastro&Urology the task is to ensure registration of a new innovative microbiome compound which is expected to be of huge importance as a solution for patients worldwide suffering by Clostridium Dificile. The second position is aimed to focus on ensuring registration in developing countries of a non-profit product against post-partum bleeding in collaboration with WHO as well as being responsible for a product with the same active substance approved world wide.
You will become an important part of Ferring’s Global Regulatory Affairs CMC department team of 38 dedicated colleagues based in five teams in Copenhagen, Israel or Switzerland.
Key responsibilities include:
In the role you will work in an international environment and have interfaces with many different disciplines including other Global Regulatory disciplines, Global Pharmaceutical R&D, Manufacturing sites, Product Supply, Ferring’s affiliates and development sites around the world.
Requirements:
Why?
Ferring Pharmaceuticals is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. At Ferring International Pharma Science Centre (IPC) in Copenhagen we are nearly 600 people, primarily scientists and specialists breaking new ground to help people live better lives all around the globe. We focus our R&D efforts on peptide-based drugs and biotechnology derived medicines.
As a privately owned company we benefit from the privilege to think and work with a long-term horizon. You will experience the same freedom in your search for new solutions. Your desire to innovate and explore will contribute to fulfilling our ambition of becoming the world’s leading company within reproductive medicine and maternal health. If you need help, you will find it. If you want challenges, they are right in front of you. If you are looking for freedom to find your own way, you are trusted to do so. If you want to make a mark in the world for the better, you feel just like the rest of us. Read more at www.ferring.com
How?
For further information do reach out to recruitment manager Lise Sønnersgaard, email [email protected] or by phone + 45 60981303 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
The 2 positions are in 2 different CMC teams: one in Gastro&Urology and one in Reproductive Medicines and Maternal Health. For the position in Gastro&Urology the task is to ensure registration of a new innovative microbiome compound which is expected to be of huge importance as a solution for patients worldwide suffering by Clostridium Dificile. The second position is aimed to focus on ensuring registration in developing countries of a non-profit product against post-partum bleeding in collaboration with WHO as well as being responsible for a product with the same active substance approved world wide.
You will become an important part of Ferring’s Global Regulatory Affairs CMC department team of 38 dedicated colleagues based in five teams in Copenhagen, Israel or Switzerland.
Key responsibilities include:
- Responsible for regulatory submissions and approvals for worldwide market expansions and renewals
- In the senior position, provide regulatory CMC strategy and expertise to cross-functional teams such as the Global Regulatory Project Teams, CMC Teams, Product teams and Launch Teams
- In the senior position, represent Global RA in the due diligence process and provide RA CMC input
- Perform regulatory impact assessment of CMC changes for established products and drug substances, ensure that adequate documentation is generated, submitted and approved timely worldwide
- In the senior position, drive and execute Scientific Advice with national Competent Authorities
- Participate actively in development and optimization of departmental and working processes
In the role you will work in an international environment and have interfaces with many different disciplines including other Global Regulatory disciplines, Global Pharmaceutical R&D, Manufacturing sites, Product Supply, Ferring’s affiliates and development sites around the world.
Requirements:
- Degree in life science or pharmacy
- For the senior position at least minimum of 7 years’ experience from a similar global RA position where RA CMC experience is a must
- For the non-senior position more than 3 years of experience in global regulatory affairs, preferably within regulatory CMC activities
- For the Gastro&Urology position, experience with biological substances is preferred as well as experience from development projects
- Experienced with MAA/NDA/BLA submissions in Europe, US and Rest of the World
- For the senior position and especially within Gastro&Urology, experience from Scientific Advice with EMA, FDA and other Health Authorities is required,
- Experienced from work with variation applications for FDA, EMA and preferably also other markets
- For the RMMH position, additional to your RA competence, experience from QA, manufacturing site or pharmaceutical R&D will be considered valuable
- Fluent in written and spoken English
- A focused, structured dedicated person able to work independently but at the same time also a true team player
- Ability to proactively drive activities, take decision and deal with ambiguity
Why?
Ferring Pharmaceuticals is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. At Ferring International Pharma Science Centre (IPC) in Copenhagen we are nearly 600 people, primarily scientists and specialists breaking new ground to help people live better lives all around the globe. We focus our R&D efforts on peptide-based drugs and biotechnology derived medicines.
As a privately owned company we benefit from the privilege to think and work with a long-term horizon. You will experience the same freedom in your search for new solutions. Your desire to innovate and explore will contribute to fulfilling our ambition of becoming the world’s leading company within reproductive medicine and maternal health. If you need help, you will find it. If you want challenges, they are right in front of you. If you are looking for freedom to find your own way, you are trusted to do so. If you want to make a mark in the world for the better, you feel just like the rest of us. Read more at www.ferring.com
How?
For further information do reach out to recruitment manager Lise Sønnersgaard, email [email protected] or by phone + 45 60981303 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
Information og data
Denne ledige stilling har jobtypen "Jurist", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Kongens Lyngby.
Jobbet er oprettet på vores service den 3.8.2021, 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.
- Jurist
- Kongens Lyngby
- Tirsdag den 31. august 2021
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