Senior Regulatory Affairs Manager , Biocides
at Knoell Germany GmbH
Deutschland, , Germany -
| Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
|---|---|---|---|---|---|---|---|
| Immediate | 18 Oct, 2024 | Not Specified | 18 Jul, 2024 | 3 year(s) or above | Regulatory Requirements,Service Providers,Team Spirit,Clinical Development | No | No |
Required Visa Status:
| Citizen | GC |
| US Citizen | Student Visa |
| H1B | CPT |
| OPT | H4 Spouse of H1B |
| GC Green Card |
Employment Type:
| Full Time | Part Time |
| Permanent | Independent - 1099 |
| Contract – W2 | C2H Independent |
| C2H W2 | Contract – Corp 2 Corp |
| Contract to Hire – Corp 2 Corp |
Description:
Responsibilities:
- You will oversee the registration process of active substances (and biocidal products) according to national and international regulatory requirements, e.g. the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012), by using your profound up to date know-how on the regulatory guidance as well as regulatory processes, costs and timelines.
- You will participate in conference calls and Web Meetings with clients to understand client needs
- Together with technical experts and authorities your focus will be on developing advanced regulatory strategies for our clients, by using your ability to interpret existing guidance.
- You will support our clients by facilitating their communication with authorities in terms of regulatory compliance by sharing your expertise on the applicable information and communication channels.
- You will be responsible to manage projects describing the dossier creation and submission process, by using your communication and organisational skills together with your regulatory expertise.
- You will assure that the work done in your projects in Biocides area is in line with current regulatory guidance and follows our internal project standards. You will be adhering to project management rules at knoell and using dedicated project management tools.
- You will begin to act as the subject matter expert in dedicated topics in the regulatory area of Biocides and you will build-up, maintain and share practical knowledge in a growing, team-oriented working group by frequently contributing to discussions in our established communication channels and meetings
- You will act as the interface with other technical teams within knoell in your capacity as project manager, by promoting your expertise through presentations and knowledge exchange within the business line.
REQUIREMENT SUMMARY
Min:3.0Max:5.0 year(s)
Pharmaceuticals
Clinical Pharmacy
Graduate
Proficient
1
Deutschland, Germany
