Job DescriptionSenior Manager - Regulatory Affairs
- £70,000 - £90,000
- Outstanding Opportunity with a world-leading Pharmaceutical business
- High profile role that will help shape regulatory strategy across a diverse product portfolio
Our client are a well-established Pharmaceutical business who have undergone some significant growth and development over the last 12 months. They have a large product portfolio that encompasses both Generic and Speciality drugs - supplied to a global customer-base.
The new Senior Regulatory Affairs Manager will be a key appointment for the business - operating at a Senior Level with key internal and external stakeholders within a global business. You will enjoy specific responsibility for:
- Driving regulatory strategy throughout drug development phases; advising during development, approval and post-approval.
- Preparing submissions to relevant Health Authorities across multiple jurisdictions
- Developing and communicating relevant regulatory strategies across a range of internal stakeholders
- Influencing working processes across your area of expertise
The successful Senior Regulatory Affairs Manager is likely to be working in a similar role at the moment; likely within a Pharmaceutical business. There are, however, some key capabilities that you will be able to demonstrate:
- A higher-level qualification (Ph.D/Pharma.D, or MSc) in a relevant scientific or health care discipline is essential
- Excellent experience of development and approval stages - including regulatory pathways and regulations is essential
- An understanding and appreciation of the difficulties of a global Research and Development process - focused on Clinical Development, Benefit and Risk Assessments and Strategic positioning/labelling is essential