Regulatory Affairs Senior Manager – Leading Generics Company – Slough with hybrid working - £ competitive and negotiable + 10% bonus, pension, healthcare, 28 days holiday + BH
A global pharmaceutical company specialising in generics, respiratory and neurology medicines is now recruiting for a Regulatory Affairs Senior Manager to join them on a permanent basis.
A global pharmaceutical client specialising in generics, neurology, and respiratory products. They currently have several products on the market along with several products in development stages.
- Global Pharmaceutical company with offices in Slough (the role will be a mix of office and remote working)
- Awarded Great Place To Work status
- 28 days A/L plus Bank Holidays
- Main areas of focus are branded and generic products, neurology, respiratory
- New products in the pipeline within women’s health, CV, diabetes, dermatology
- World class manufacturing sites across multiple countries globally
The Regulatory Affairs Senior Manager is responsible for;
- Define regulatory strategy and provide guidance on regulatory requirements for new product development
- 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.
- Support the lifecycle management of existing products.
- Support establishment of key processes within the RA function in Europe.
To apply for this role as Regulatory Affairs Senior Manager our client is hoping for someone with the following skills and experience;
- An excellent understanding of European regulatory requirements
- Ability to set up regulatory strategies in support of development programs for generic and specialty products, focusing mainly on EU.
- Significant EU regulatory experience
- Leading scientific advice procedures, managing regulatory approval processes and line extension applications through to the granting of the MA.
- Manage the product lifecycle, including Marketing Authorization submissions, (DCPs, MRPs), set up and implement post-approval line-extension and variation strategies, maintenance activities.
What should you do next?
This Regulatory Affairs Senior Manager role is one not to be missed; it encompasses the opportunity to work for a market leading, global generics company. To discuss this Regulatory Affairs Senior Manager role further or to find out about other Regulatory Affairs jobs I’m currently working on, please get in touch or hit apply to submit your current CV.
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