Head of Regulatory Affairs CMC
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Ballerup
Can you deliver positive leadership and set the global direction for regulatory affairs CMC
in a time of rapid growth?
LEO Pharma has set the ambitious goal to become the world’s preferred dermatology care partner. To succeed, we invest massively in development at all levels, including R&D. As a result, our pipeline is growing rapidly in size and complexity, and therefore we need all your skills as leader, scientist and regulatory expert to build and set the bar for global regulatory CMC strategy.
You will join LEO Pharma at a very exciting period in the company’s history, and you can look forward to influence and impact on the shaping of your own job as well as the overall direction for the global regulatory CMC organisation in LEO Pharma.
Taking quality regulatory decisions, balancing risks and benefits
As Head of Regulatory Affairs CMC you will be responsible for the regulatory CMC strategy in submissions for all products under your responsibility as well as being involved in interactions with regulatory authorities on CMC issues, working in partnership with R&D including Pharmaceutical Development Department, Global Product Supply, and QA.
You will head three teams, including CMC Device, CMC biologics, and CMC small molecules with approx. a total of 25 highly motivated employees, based at LEO Pharma’s headquarters in Ballerup, Copenhagen as well as in Dublin, Ireland. Your overall objective is to manage all regulatory CMC aspects of LEO Pharma’s products throughout their lifecycle, and your primary tasks will be to:
You can look forward to travel 20-40 days per year to meet colleagues and partners.
Experienced with strategic, global CMC Regulatory affairs and solid leadership skills
You have both large and small molecule experience as well as device regulation knowledge as they apply throughout the different development phases as well as lifecycle management of marketed products.
You have a natural science degree like Pharmacist, PhD or similar. This is backed by solid experience within clinical development and regulatory affairs within CMC on global scale, e.g. gained as Regulatory Lead or Project manager in connection with large development projects. This has provided you with a strong knowledge base of Regulatory CMC on a global level for both development and maintenance phases of pharmaceuticals. You are recognised for being able to identify multiple regulatory opportunities, and for your ability to clearly communicate regulatory constraints, risks, and mitigation opportunities.
You have experience as people manager and you are known for your open-minded and positive leadership style. Even though you thrive on setting the direction and taking the lead, nothing motivates you like making your people shine and be their best. Additionally, you have the toolbox to build, motivate and inspire high performance teams with a common drive for success. In this you take benefit from your excellent communication skills that enable you to bring your messages across in an easy understandable way, written as spoken. As part of a rapidly growing organisation you must also thrive in an environment of change and be able to navigate safely without having manuals and updated SOP’s for each and every process.
We look forward to receiving your application.
Kilde: Jobnet.dk
in a time of rapid growth?
LEO Pharma has set the ambitious goal to become the world’s preferred dermatology care partner. To succeed, we invest massively in development at all levels, including R&D. As a result, our pipeline is growing rapidly in size and complexity, and therefore we need all your skills as leader, scientist and regulatory expert to build and set the bar for global regulatory CMC strategy.
You will join LEO Pharma at a very exciting period in the company’s history, and you can look forward to influence and impact on the shaping of your own job as well as the overall direction for the global regulatory CMC organisation in LEO Pharma.
Taking quality regulatory decisions, balancing risks and benefits
As Head of Regulatory Affairs CMC you will be responsible for the regulatory CMC strategy in submissions for all products under your responsibility as well as being involved in interactions with regulatory authorities on CMC issues, working in partnership with R&D including Pharmaceutical Development Department, Global Product Supply, and QA.
You will head three teams, including CMC Device, CMC biologics, and CMC small molecules with approx. a total of 25 highly motivated employees, based at LEO Pharma’s headquarters in Ballerup, Copenhagen as well as in Dublin, Ireland. Your overall objective is to manage all regulatory CMC aspects of LEO Pharma’s products throughout their lifecycle, and your primary tasks will be to:
- Formulate, lead, and, proactively communicate CMC regulatory strategy, key issues and mitigation strategies to relevant stakeholders in a timely manner.
- Lead global CMC submission activities including identifying required content to ensure compliance in meeting global regulatory requirements especially US, EU, Japan, China, Russia, and Brazil and increase probability of regulatory approval.
- Ability to interpret Regulatory Authority CMC policies, guidance, and emerging trends and correctly apply them as appropriate in product development and post-approval activities.
- Develop performance measures and key delivery targets and goals for Global Regulatory Affairs CMC in alignment with stakeholders.
- Manage and develop direct reports and ensure that the department objectives are met and implemented according to regulatory KPI’s.
You can look forward to travel 20-40 days per year to meet colleagues and partners.
Experienced with strategic, global CMC Regulatory affairs and solid leadership skills
You have both large and small molecule experience as well as device regulation knowledge as they apply throughout the different development phases as well as lifecycle management of marketed products.
You have a natural science degree like Pharmacist, PhD or similar. This is backed by solid experience within clinical development and regulatory affairs within CMC on global scale, e.g. gained as Regulatory Lead or Project manager in connection with large development projects. This has provided you with a strong knowledge base of Regulatory CMC on a global level for both development and maintenance phases of pharmaceuticals. You are recognised for being able to identify multiple regulatory opportunities, and for your ability to clearly communicate regulatory constraints, risks, and mitigation opportunities.
You have experience as people manager and you are known for your open-minded and positive leadership style. Even though you thrive on setting the direction and taking the lead, nothing motivates you like making your people shine and be their best. Additionally, you have the toolbox to build, motivate and inspire high performance teams with a common drive for success. In this you take benefit from your excellent communication skills that enable you to bring your messages across in an easy understandable way, written as spoken. As part of a rapidly growing organisation you must also thrive in an environment of change and be able to navigate safely without having manuals and updated SOP’s for each and every process.
We look forward to receiving your application.
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Smed", og befinder sig i kategorien "Industri, håndværk og teknik".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 27.2.2020, 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.
- Smed
- Ballerup
- Søndag den 08. marts 2020
Lignende jobs
-
Dygtige klejnsmede søges
Dygtige klejnsmede søges. Er du en erfaren og dygtig klejnsmed med ekspertise inden for rustfri smedearbejde og TIG-svejsning? Har du erfaring med ALU og et gyldigt kørekort? Så er det måske dig,.Få mere info- Smed
- Storkøbenhavn
-
Rustfaste smede søges
Rustfaste smede søges.Vil du arbejde i en god virksomhed med stort vækstpotentiale, mange, spændende opgaver og gode kollegaer? Vores kunde søger til opstart snarest muligt to rustfast smede – en t..Få mere info- Smed
- Storkøbenhavn
-
Smede til Sort og Rustfri Opgaver
Smede til sort og rustfri opgaverEr du en dygtig smed med erfaring inden for både sort og rustfri stål? Vil du være en del af et spændende projekt i København, der strækker sig over seks måneder? S..Få mere info- Smed
- København
-
Svejser
Hos Alfa Laval går vi altid den ekstra kilometer for at overvinde de sværeste udfordringer. Vores mål er at skabe succes sammen med vores kunder, mennesker og planet. Det kan du kun opnå ved at hav..Få mere info- Smed
- Søborg
Statistik over udbudte jobs som smed i Ballerup
Herunder ser du udviklingen i udbudte smed i Ballerup 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 smed.
Se flere statistikker her:
Statistik over udbudte smed i Ballerup over tid
| Dato | Alle jobs som smed |
|---|---|
| 9. november 2024 | 0 |
| 8. november 2024 | 0 |
| 7. november 2024 | 0 |
| 6. november 2024 | 0 |
| 5. november 2024 | 0 |
| 4. november 2024 | 0 |
| 3. november 2024 | 0 |
| 2. november 2024 | 0 |
| 1. november 2024 | 0 |
| 31. oktober 2024 | 0 |
| 30. oktober 2024 | 0 |
| 29. oktober 2024 | 0 |
| 28. oktober 2024 | 0 |
| 27. oktober 2024 | 0 |
| 26. oktober 2024 | 0 |
| 25. oktober 2024 | 0 |
| 24. oktober 2024 | 0 |
| 23. oktober 2024 | 0 |
| 22. oktober 2024 | 0 |
| 21. oktober 2024 | 0 |
| 20. oktober 2024 | 0 |
| 19. oktober 2024 | 0 |
| 18. oktober 2024 | 0 |
| 17. oktober 2024 | 0 |
| 16. oktober 2024 | 0 |
| 15. oktober 2024 | 0 |
| 14. oktober 2024 | 0 |
| 13. oktober 2024 | 0 |
| 12. oktober 2024 | 0 |
| 11. oktober 2024 | 0 |
| 10. oktober 2024 | 0 |