Senior Regulatory Compliance Associate

Real Staffing have partnered with a global Pharmaceutical company, with an exciting and impressive pipeline. Their product is a world leader in its market.

Due to an increase in work demand, they are currently seeking a Senior Regulatory Compliance Associate, for initially 6 months, based at their site in Berkshire.

Role Responsibilities:

• To work closely with the Regulatory teams to ensure that submissions are in accordance with company standards and regulatory requirements
• To Conduct preliminary compliance review of submission documents
• Writing and reviewing SOP documents
• Act as the POC for internal and health authority inspections
• Keep an eye on changes with industry standards and report this to senior management and key stakeholders
• A good understanding of NDA/MAA products

The ideal post-holder will have:

• a BSc (or equivalent) in a life sciences (or related) field
• At least 5 years of experience within the life sciences (or related) industry
• At least 2 years of experience working within a similar regulatory compliance role
• Knowledge of NDA/MAA products (desirable)
• Knowledge of international regulatory guidelines (FDA/EMA)

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales