My client, a Global Pharmaceutical Company, has opened a new vacancy within their Regulatory team and are actively looking to recruit a Senior Regulatory Labelling...
SRG are currently looking for Regulatory Senior Executive for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team to be based at their offices in Middlesex on an initial 9 month contract.
Prepare high quality, Chemistry, Manufacturing and Control detailed regulatory documents using varied information sources. Work to agreed deadlines and maintaining records to reflecting project status and to be responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice.
- Post Approval CMC experience preferential.
- CMC authoring experience essential (previous co-ordination role is not sufficient). This should include authoring of module 3 and authoring of CMC variations.
- Experience responding to manufacturing site change controls and providing regulatory advice and strategies.
- Detailed proven CMC knowledge and experience for EU and EMAP region.
- Understands CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Ability to manage multiple project assignments/teams simultaneously and provide data assessment and conclusions.
- Identifies risks associated with submission data and information packages and ability to propose mitigation actions.
- Ability to efficiently interact with customers and senior stakeholders as required
- Identifies improvement opportunities for CMC Regulatory processes, policies and systems.
- Good communication skills and flexible approach - " can do attitude"
- May contribute to process improvement and/or regulatory intelligence projects
Education & Skills
- Minimum degree level in any life sciences.
- CMC experience (in depth experience required)
- Good written and oral communication and networking skills
- Demonstrate ability to focus and work with attention to detail
- Demonstrate ability to retain critical information
- Be aware of the contents of a marketing authorization application
- Demonstrate team working and effective time management skills
- Be a dynamic and highly motivated individual
- Establish strong relationships and liaise effectively with sites worldwide
- Be proficient in the use of IT packages such as Word and excel.
- Demonstrate problem solving skills
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@SRG.co.uk or +441753 589673