Head of Regulatory Affairs CMC
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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:
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.
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.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 15.10.2019, 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.
- Afdelingsleder
- Ballerup
- Søndag den 08. marts 2020
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Statistik over udbudte afdelingsleder i Ballerup over tid
| Dato | Alle jobs som afdelingsleder |
|---|---|
| 19. september 2024 | 11 |
| 18. september 2024 | 11 |
| 17. september 2024 | 11 |
| 16. september 2024 | 10 |
| 15. september 2024 | 11 |
| 14. september 2024 | 11 |
| 13. september 2024 | 11 |
| 12. september 2024 | 11 |
| 11. september 2024 | 12 |
| 10. september 2024 | 11 |
| 9. september 2024 | 10 |
| 8. september 2024 | 10 |
| 7. september 2024 | 10 |
| 6. september 2024 | 10 |
| 5. september 2024 | 10 |
| 4. september 2024 | 9 |
| 3. september 2024 | 9 |
| 2. september 2024 | 9 |
| 1. september 2024 | 9 |
| 31. august 2024 | 11 |
| 30. august 2024 | 13 |
| 29. august 2024 | 13 |
| 28. august 2024 | 13 |
| 27. august 2024 | 13 |
| 26. august 2024 | 14 |
| 25. august 2024 | 14 |
| 24. august 2024 | 15 |
| 23. august 2024 | 15 |
| 22. august 2024 | 14 |
| 21. august 2024 | 16 |
| 20. august 2024 | 17 |