The Role
The Regulatory Affairs Senior Manager is responsible for;
1. Define regulatory strategy and provide guidance on regulatory requirements for new product development
2. Activities include scientific advice preparation and meetings, review and submission of generic, hybrid and full MAs to European health authorities through National, CP, DCP or MR procedures.
3. Support the lifecycle management of existing products.
4. Support establishment of key processes within the RA function in Europe.
You
To apply for this role as Regulatory Affairs Senior Manager our client is hoping for someone with the following skills and experience;
5. An excellent understanding of European regulatory requirements
6. Ability to set up regulatory strategies in support of development programs for generic and specialty products, focusing mainly on EU.
7. Significant EU regulatory experience
8. Leading scientific advice procedures, managing regulatory approval processes and line extension applications through to the granting of the MA.
9. Manage the product lifecycle, including Marketing Authorization submissions, (DCPs, MRPs), set up and implement post-approval line-extension and variation strategies, maintenance activities.