Regulatory Science Specialist
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Køge
Regulatory Science Specialist
Take a vital role in helping life science companies getting their products on the market by utilizing your regulatory affairs expertise!
https://uhc.dk/wp-content/uploads/2021/10/Regulatory_Scientist_IWA.mp4
IWA Consulting is a dedicated group of Regulatory Science Specialists with long term regulatory experience. They are assisting Pharma and Biotech companies in achieving their major regulatory milestones by thoroughly understanding the sense of urgency that applies to this business area.
Joining the IWA Consulting team implies a unique opportunity to learn, develop professionally, and make good use of your knowledge in a vital role to the clients. By combining strategic, scientific, and operational expertise, IWA Consulting ensures successful execution of regulatory submissions throughout the development phase, the registration phase, and the post-approval phase thereby supporting the clients’ key business goals.
You will assist clients with a variety of regulatory tasks including the following:
Regulatory Strategy preparation:
Project Management and Procedure Management:
Preparation and submission of all types of regulatory documents and dossiers:
Preparation and updating of Product Information text:
Medical/technical writing:
Teaching/speaking at courses and conferences:
Your qualifications include a Master’s Degree in life science combined with a few years of experience with some of the regulatory scientific disciplines. You are passionate about regulatory affairs and have a basic knowledge of drug developmebnt and pharmacutical regulatory affairs combined with a scientific mindset.
You have excellent communication skills (English is a must) and communicate efficiently with stakeholders at all organisational levels and within all scientific diciplines (quality, non-clinical, clinial). Further, you have good organizational and interpersonal skills, with the ability to manage multiple priorities and work with tight deadlines, while beeing collaborative and consultative toward the clients, developing effective working relationsships.
You are a person with a proactive and responsible attitude and are driven by a high commitment to delivering results on time, every time. You are flexible, service-minded and adaptable and you can handle and deliver on routine jobs when nessesary, while at the same time, you are not afraid to learn new things and do things differently.
IWA Consulting offers an exciting and challenging position in a well-consolidated company with a short line of command and a high degree of flexibility in your everyday life. You will join a company that prides itself of having deep insight and thorough understanding of the regulatory field for medicines, medical devices, and combination products and work together with highly skilled and experienced colleagues. This provide a unique chance to develop your skills within the RA diciplin and help build the future of the company.
Domicile: Depending on the clients’ needs the work may be carried out on-site at the clients’ offices as part of their team of regulatory specialists, or from the IWA Consulting offices in Køge or in Copenhagen, COBIS Science Park.
For more details about the job or the company, please contact Senior Research Consultant, Jeanne Dederding, Unique Human Capital on M: +45 28 74 58 71. All applications must be in English and are treated confidentially.
Take a vital role in helping life science companies getting their products on the market by utilizing your regulatory affairs expertise!
https://uhc.dk/wp-content/uploads/2021/10/Regulatory_Scientist_IWA.mp4
IWA Consulting is a dedicated group of Regulatory Science Specialists with long term regulatory experience. They are assisting Pharma and Biotech companies in achieving their major regulatory milestones by thoroughly understanding the sense of urgency that applies to this business area.
Joining the IWA Consulting team implies a unique opportunity to learn, develop professionally, and make good use of your knowledge in a vital role to the clients. By combining strategic, scientific, and operational expertise, IWA Consulting ensures successful execution of regulatory submissions throughout the development phase, the registration phase, and the post-approval phase thereby supporting the clients’ key business goals.
You will assist clients with a variety of regulatory tasks including the following:
Regulatory Strategy preparation:
- Prepare regulatory strategies and provide input to regulatory strategies for pharma projects. Identify and provide relevant regulatory guidance to clients, incl. defining the regulatory path.
Project Management and Procedure Management:
- Project Management for regulatory activities on pharmaceutical products, incl. management of US and EU regulatory procedures (incl. MAA, NDA, IND, CTA, ODD, PIP, variations, renewals, and other post-approval activities).
- Planning, coordinating and participating in meetings with authorities.
Preparation and submission of all types of regulatory documents and dossiers:
- Preparation and/or review of documentation for regulatory submissions, incl. MAA, NDA, IND, CTA, ODD, PIP, variations, and renewals.
- Preparing for, and review of, eCTD submissions.
Preparation and updating of Product Information text:
- Preparation and updating SmPC, PIL and Labelling.
Medical/technical writing:
- Medical/technical writing for pharma products.
Teaching/speaking at courses and conferences:
- Teaching/speaking at courses, conferences or similar on various subjects according to existing and acquired key competencies.
Your qualifications include a Master’s Degree in life science combined with a few years of experience with some of the regulatory scientific disciplines. You are passionate about regulatory affairs and have a basic knowledge of drug developmebnt and pharmacutical regulatory affairs combined with a scientific mindset.
You have excellent communication skills (English is a must) and communicate efficiently with stakeholders at all organisational levels and within all scientific diciplines (quality, non-clinical, clinial). Further, you have good organizational and interpersonal skills, with the ability to manage multiple priorities and work with tight deadlines, while beeing collaborative and consultative toward the clients, developing effective working relationsships.
You are a person with a proactive and responsible attitude and are driven by a high commitment to delivering results on time, every time. You are flexible, service-minded and adaptable and you can handle and deliver on routine jobs when nessesary, while at the same time, you are not afraid to learn new things and do things differently.
IWA Consulting offers an exciting and challenging position in a well-consolidated company with a short line of command and a high degree of flexibility in your everyday life. You will join a company that prides itself of having deep insight and thorough understanding of the regulatory field for medicines, medical devices, and combination products and work together with highly skilled and experienced colleagues. This provide a unique chance to develop your skills within the RA diciplin and help build the future of the company.
Domicile: Depending on the clients’ needs the work may be carried out on-site at the clients’ offices as part of their team of regulatory specialists, or from the IWA Consulting offices in Køge or in Copenhagen, COBIS Science Park.
For more details about the job or the company, please contact Senior Research Consultant, Jeanne Dederding, Unique Human Capital on M: +45 28 74 58 71. All applications must be in English and are treated confidentially.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Køge.
Jobbet er oprettet på vores service den 6.10.2021, 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.
- Øvrige
- Køge
Lignende jobs
-
Change-oriented LEAN(R) Partner
Are you a strong communicator with business understanding and the ability to facilitate change through people? And do you thrive working with process development and to drive the LEAN agenda in Mai..Få mere info- Øvrige
- Kalundborg
-
Teamleder - Fuldtid - Køge
Vi søger en teamleder til vores aftenhold i vores ferskvareafdeling på vores lager i Køge. Det bliver din opgave som teamleder at være med til at sikre den højeste kvalitet i vores leverancer af fr..Få mere info- Øvrige
- Køge
-
Head of Project Controls
Do you have management experience in project controlling and/or cost engineering? Are you driven and eager to join Novo Nordisk’s very comprehensive and still-growing project portfolio of some of t..Få mere info- Øvrige
- Kalundborg
-
Konsulent til controlling i Det Nære Sundhedsvæsen
Din næste karrieremulighed venter på dig Vil du arbejde i en udviklingsorienteret og ambitiøs organisation, hvor målet er at bringe sundhedsydelserne tættere på borgerne? Er du intern revis..Få mere info- Øvrige
- Sorø
Statistik over udbudte jobs som øvrige i Køge
Herunder ser du udviklingen i udbudte øvrige i Køge over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal øvrige.
Se flere statistikker her:
Statistik over udbudte øvrige i Køge over tid
| Dato | Alle jobs som øvrige |
|---|---|
| 15. september 2024 | 34 |
| 14. september 2024 | 39 |
| 13. september 2024 | 39 |
| 12. september 2024 | 38 |
| 11. september 2024 | 39 |
| 10. september 2024 | 38 |
| 9. september 2024 | 35 |
| 8. september 2024 | 35 |
| 7. september 2024 | 37 |
| 6. september 2024 | 35 |
| 5. september 2024 | 26 |
| 4. september 2024 | 26 |
| 3. september 2024 | 26 |
| 2. september 2024 | 25 |
| 1. september 2024 | 28 |
| 31. august 2024 | 30 |
| 30. august 2024 | 30 |
| 29. august 2024 | 30 |
| 28. august 2024 | 26 |
| 27. august 2024 | 26 |
| 26. august 2024 | 25 |
| 25. august 2024 | 29 |
| 24. august 2024 | 29 |
| 23. august 2024 | 28 |
| 22. august 2024 | 28 |
| 21. august 2024 | 29 |
| 20. august 2024 | 31 |
| 19. august 2024 | 31 |
| 18. august 2024 | 30 |
| 17. august 2024 | 31 |
| 16. august 2024 | 32 |