Position Summary:
This is a temp/$65 ph TO perm/$130k per year. NO AGENCIES!

• To support business in maintaining regulatory compliance of existing manufactured products for customers on a global basis.
• Managing regulatory compliance activities and existing customer products and registrations as required and providing strategic planning for regulatory changes.
• Acting as the regulatory lead for site-specific activities (e.g., Quality Reviews, Change Committees, etc.) 
• Co-ordinating and preparing regulatory documentation for clinical trial applications, Drug Master Files (DMFs), medical device technical documentation and registration CTD documents (where required).
• Managing or mentoring more junior staff as required to achieve the business and role goals and objectives. 

Requirements:
• Graduate in pharmacy or a life science (or equivalent). 
• Additional regulatory qualifications advantageous. 
• 12-15 years relevant experience of US, European or Global registration procedures (or significant experience in other areas of the pharmaceutical industry). 
• In-depth knowledge of the Global Regulatory Affairs environment – Guidelines and legislation.
• Deep practical knowledge of the drug regulatory processes in the US and background understanding of regulatory processes in other regions.
• General understanding of drug development and pharmaceutical manufacturing from concept to launch including requirements for product development, manufacturing and marketing and the impact of regulatory changes on business goals/objectives. ·
Broad understanding of the pharmaceutical business in general and of other relevant associated regulatory areas (e.g., Clinical Affairs, Medical Devices, Chemicals Regulations, etc.).