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As the new Regulatory Submissions Lead, you will report to the Regulatory submissions manager and assist in the departmental processes for APTL products and brands. You will assist a team of Regulatory Affairs Officers and prepare regulatory submissions assigned to the submission team. You will ensure the documentation prepared by Regulatory Affairs Officers is complete and complies with applicable regulatory requirements. You will also be responsible for negotiating and communicating effectively with other functions and regional officers to obtain timely product approvals.
As part of the remit, you will also:
- Ensure all activities are within the framework of the Quality system, including the setting and achievement of relevant KPIs - Provide the cross-functions team with Regulatory input in order to obtain timely regulatory approvals for the products - Maintain and enhances cross-functional team relationships The Person
The ideal candidate will be degree qualified or post graduate degree in Science. You will have a minimum of 3 years experience working within a Pharmaceutical environment managing a small team of Regulatory Affairs Associates and/or Officers. you will also need good knowledge of regulatory submissions with Branded products.
As part of the individual requirements, you will also have:
- Team management and leadership skills - Strategic planning and decision making skills - Ability to work under pressure and to tight deadlines
Salary negotiable Competitive benefits package
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 Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales