We are looking for candidates who understand & auhtor tecnhical content of Module 3 dossiers and worked directly with manufacturing sites
Our client a Global Pharmaceutical Company have opened a new vacancy within there Regulatory team and are looking to recruit x2 Senior Regulatory Executive's on 12 month contracts based in Brentford after COVID.
- Post Approval CMC experience
- 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
- CMC experience
- 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 company 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@srgtalent.com or +441753 589673
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