Regulatory Affairs Manager – Leading Generics Company – Slough with hybrid working - £ competitive and negotiable + 8% 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 Manager to join them on a permanent basis.

The Company

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 Role

The Regulatory Affairs 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.

You

To apply for this role as Regulatory Affairs 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 Authorisation submissions, (DCPs, MRPs), set up and implement post-approval line-extension and variation strategies, maintenance activities.

What should you do next?

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we'll be more than happy to assist.