Regulatory Affairs Manager
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Nordsjælland
Regulatory Affairs Manager
Exciting opportunity as Regulatory Affairs Manager (RA Manager) within topical drug products.
https://uhc.dk/wp-content/uploads/2021/01/Regulatory_Affairs_Man_MC2-1-NY.mp4
As MC2 Therapeutics is expanding, they are looking for experienced RA Manager(s) for newly established position(s) to take responsibility for regulatory activities related to life cycle management, regulatory CMC, and pharmacovigilance. It is a requirement for the successful applicant to have significant knowledge and experience in a subset of the following areas, but not necessarily all of them.
With direct report to the COO and in cooperation with VP RA.
Your main responsibilitieswill, depending on candidate profile, include:
RA-lifecycle management
RA–CMC
Pharmacovigiliance
General
Your qualifications are 5-10 years of experience from the pharmaceutical or biotech industry, including regulatory activities and pharmacovigiliance related to drug products. Ideally, but not necessarily you have regulatory experience with the field of cosmetics and biocides (hand sanitizer) in addition to drugs. You have a good knowledge of European and US pharmaceutical legislation, relevant guidelines, procedures and requirements. Finally, you have strong regulatory writing skills, and excellent problem solving, communication and strategic planning skills.
You have a Master’s Degree in Pharmaceuticals or the like.
You are a person who is very structured in your working methods with attention to details, and you have a systematic/organized approach that sets high quality standards. You are a team-player, able to positively influence team members at all levels with a “can do” attitude. You are proactive, a quick learner and an independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion. You are also open-minded and have a good sense of humour, while when necessary you must be robust and able to both listen to and stand firm on valid arguments.
Travelling: Approx. 5-15 days per year.[Linjeskift til tekstombrydning]
Domicile: Hørsholm, North of Copenhagen.
For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant Anne Thomsen, Unique Human Capital on M: +45 31 40 01 11. All applications must be in English and are treated confidentially.
Exciting opportunity as Regulatory Affairs Manager (RA Manager) within topical drug products.
https://uhc.dk/wp-content/uploads/2021/01/Regulatory_Affairs_Man_MC2-1-NY.mp4
As MC2 Therapeutics is expanding, they are looking for experienced RA Manager(s) for newly established position(s) to take responsibility for regulatory activities related to life cycle management, regulatory CMC, and pharmacovigilance. It is a requirement for the successful applicant to have significant knowledge and experience in a subset of the following areas, but not necessarily all of them.
With direct report to the COO and in cooperation with VP RA.
Your main responsibilitieswill, depending on candidate profile, include:
RA-lifecycle management
- Regulatory activities associated with life cycle management activities in the US, the EU and globally – including
- Regulatory advice to the product/project teams
- Develop timelines for lifecycle management activities and ensure execution
- Develop and/or review regulatory documents, including product labelling, in cooperation with subject matter experts
- Contact to regulatory authorities
- Contribution to regulatory strategies for the MC2 product portfolio
- Submission management of activities related to lifecycle management
RA–CMC
- Provide CMC regulatory advice to the project teams on global development programs
- Develop timelines for CMC parts of the dossier and follow up with subject matter experts
- Develop and/or review regulatory CMC documents
- Review and provide regulatory assessment to proposed CMC changes (Change Control system)
- Preparation of responses to CMC questions from Regulatory Authorities
- Participate in submission management of CMC part
Pharmacovigiliance
- Management of safety reporting through external pharmacovigilance vendor (clinical phase/post-marketing)
General
- Archiving of regulatory documents
- Support regulatory management system
- Support QMS from a regulatory perspective
- Maintain knowledge of current global rules, regulations, and guidance governing development of drugs in all phases of development – and during maintenance
Your qualifications are 5-10 years of experience from the pharmaceutical or biotech industry, including regulatory activities and pharmacovigiliance related to drug products. Ideally, but not necessarily you have regulatory experience with the field of cosmetics and biocides (hand sanitizer) in addition to drugs. You have a good knowledge of European and US pharmaceutical legislation, relevant guidelines, procedures and requirements. Finally, you have strong regulatory writing skills, and excellent problem solving, communication and strategic planning skills.
You have a Master’s Degree in Pharmaceuticals or the like.
You are a person who is very structured in your working methods with attention to details, and you have a systematic/organized approach that sets high quality standards. You are a team-player, able to positively influence team members at all levels with a “can do” attitude. You are proactive, a quick learner and an independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion. You are also open-minded and have a good sense of humour, while when necessary you must be robust and able to both listen to and stand firm on valid arguments.
Travelling: Approx. 5-15 days per year.[Linjeskift til tekstombrydning]
Domicile: Hørsholm, North of Copenhagen.
For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant Anne Thomsen, Unique Human Capital on M: +45 31 40 01 11. All applications must be in English and are treated confidentially.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Nordsjælland
Jobbet er oprettet på vores service den 13.1.2021, 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.
- Apoteker
- Nordsjælland
Lignende jobs
-
Compliance Specialist, GMP Pharma, BIOFAC / 1887
Compliance Specialist, GMP Pharma, BIOFAC / 1887 VirksomhedenOrthana A/S indgår i BIOFAC koncernen og er beliggende i Kastrup. Det er en 100 % danskejet, bi..- Apoteker
- Klampenborg
-
Principal Scientists for in vivo pharmacology rese...
Do you want responsibility, trust, learning opportunities and great colleagues?If your experience and professional interest is founded in drug discovery, development of preclinical models and coo..- Apoteker
- Hørsholm
-
Global Senior Regulatory Affairs Specialist
Driven by the passion to improve quality of people’s lives, WS Audiology continues to grow as market leader in the hearing aid industry. With our commitment to increase penetration in an underserve..- Apoteker
- Lynge
-
Introduktionsstilling med forskningsindhold i Klin...
Vi søger en læge til en et-årig introduktionsstilling (nr. [xxxxx]i-01) til besættelse 1. december 2024 eller snarest derefter. Om afdelingen Klinisk Biokemisk Afdeling, Nordsjællands Ho..- Apoteker
- Hillerød
Statistik over udbudte jobs som apotekere i Nordsjælland
Herunder ser du udviklingen i udbudte apoteker i Nordsjælland 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 apotekere i Nordsjælland.
Se flere statistikker her:
Statistik over udbudte apotekere i Nordsjælland over tid
Dato | Alle jobs som apotekere |
---|---|
15. september 2024 | 11 |
14. september 2024 | 11 |
13. september 2024 | 11 |
12. september 2024 | 11 |
11. september 2024 | 11 |
10. september 2024 | 11 |
9. september 2024 | 10 |
8. september 2024 | 11 |
7. september 2024 | 11 |
6. september 2024 | 11 |
5. september 2024 | 10 |
4. september 2024 | 11 |
3. september 2024 | 11 |
2. september 2024 | 11 |
1. september 2024 | 9 |
31. august 2024 | 9 |
30. august 2024 | 9 |
29. august 2024 | 9 |
28. august 2024 | 8 |
27. august 2024 | 8 |
26. august 2024 | 8 |
25. august 2024 | 9 |
24. august 2024 | 9 |
23. august 2024 | 10 |
22. august 2024 | 9 |
21. august 2024 | 9 |
20. august 2024 | 9 |
19. august 2024 | 8 |
18. august 2024 | 8 |
17. august 2024 | 8 |
16. august 2024 | 8 |
Populære søgninger
Lignende søgeresultater
Farmakonomer/laboranter til Hospitalsapoteket
- Hospitalsapoteket, Serviceproduktion
Se alle populære søgninger