Job Description
Pro4orm People Ltd have partnered with a global pharmaceutical company in the search of a Senior Regulatory Affairs Manager.
We are looking to speak to people who have an excellent understanding and experience of European Regulatory requirements. This role is perfect for someone who is highly motivated, detail orientated and has a broad understanding of the requirements to place products on the market within the EU.
This is a full time permanent position, based in Berkshire three days a week.
Key Responsibilities:
1. This role will provide strategic regulatory and scientific support on non‐clinical and clinical development plans with an objective of getting fast access of innovative medicines to patients in the most efficient way.
2. Provide regulatory input into development programs, registration documentation based on relevant regulatory guidance and critical assessment of data available for generic and speciality products.
3. Identify the various guidelines relevant to product development and registration in the European region.
4. Identify and analyse relevant guidance and provide input and make recommendation to team and/or key stakeholders.
5. Critically evaluate data and scientific rationale to identify gaps and pre‐empt deficiencies prior to critical document closure in preparation of sub...