Regulatory Affairs Lead

2 months ago


Reading, United Kingdom IQVIA Full time

IQVIA have a fantastic opportunity for a Regulatory Affairs Lead to work for a growing pharmaceutical company. You will be joining a small team responsible for a range of products and therapy areas. It is a fantastic time to join the company as they are lots of growth potential and exciting plans for the near future. The role is a permanent, headcount position with hybrid working.

The Regulatory Affairs Lead will be responsible in leading all functions of Regulatory, Quality and Compliance. You will be supporting business growth by providing quality/ regulatory support to all areas of the business whilst maintaining compliance with all aspects of GxP legislation.

You will play a critical role in articulating the strategy of the function as well as in planning and implementing the strategy across the business. This is a great opportunity as you will guide and influence business decisions toward maximizing growth, while eliminating unnecessary complexity and minimizing lower-returning activities.

We are looking for individuals with the following experience:

- Degree in Life Science preferably pharmacy or chemistry
- 3+ years of experience in a senior role in Regulatory Affairs and should be accustomed to delivering guidance and leadership across a commercial organisation, reporting to the Executive Board and interfacing with all departments
- Previous management responsibility for key departments such as Pharmacovigilance and Quality Assurance
- Experience in managing a team
- Practical experience and demonstrable knowledge of third-party auditing and compliance with relevant certification and accreditation standards.
- Experience in developing and submitting product dossiers to agencies in different countries for registration
- Clear understanding of the path that a new medicine needs to navigate in order to be successfully marketed.
- Internal auditor trained.

A generous salary and comprehensive package will be provided including car allowance, bonus and a selection of benefits.



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