- 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.
Regulatory Affairs Medical Device - Los Angeles, United States - Medvacon Talent Acquisition Llc
Description
Position Summary:To support business in maintaining regulatory compliance of existing manufactured products for customers on a global basis.
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.).