Job Reference: J5631149
Updated On: 18/03/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Regulatory Affairs Manager to join a leading Pharmaceutical Company based in Hertfordshire. This is an exciting opportunity for a Regulatory Affairs Professional who is looking to take ownership of their own activities as well as expand their skills set into Project Management of client API Manufacturing projects.
As the Regulatory Affairs CMC Manage you will spend the majority of your time maintaining current registrations as well as ensuring the new registration of Active Pharmaceutical Ingredients but will also speak with and manage client projects.
Key Duties and ResponsibilitiesYour duties as the Regulatory Affairs CMC Manager will be varied however the key duties and responsibilities are as follows:
1. Manage the Life cycle for existing API products including the review, editing and submission the required documentation.
2. Work cross functionally to support the generation of information for new ASMF (Active Substance Master Files) and DMF (Drug Master Files).
3. Ensure that all staff are trained to support ASMP and CEP submissions.
4. Manage new API client projects and ensure that specific project timelines are met.
Role RequirementsTo be successful in your application to this exciting opportunity as the Regulatory Affairs CMC Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Chemistry, Pharmacology, Pharmacy etc.) in addition to some experience of working in a Regulatory Affairs environment.
2. Ideally, industry experience in the Manufacturing of API's and will as experience of the Regulatory activities in relation to the registration of ASMF within EU, US and RoW regions. Extensive CMC writing experience will be considered.
3. A working knowledge and practical experience working with the EDQM to obtain a CEP will be beneficial in your application.
Key Words: Regulatory Affairs | Project Manager | Project Management | CMC | API | ASMF | CEP | ASMF registration | API Registration | EDQM | Pharmaceutical | Herbal | Botanical | Life Cycle Management | Variations | Renewals
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