Our Client a Global Pharmaceutical Company has opened a new vacancy within there Regulatory team and are looking to recruit a Regulatory Knowledge Specialist on...
- Specific project is being started to define content templates for all module 3 submission documents.
- This is for small molecule, biologics and Devices (combination products) EU and US experience a must, China or Japan experience an asset.
- Need for lead of this project, who can compile the content templates.
- May also help with general GRA-CMC product's needs (depending on availability).
- Provide regulatory CMC leadership on the cross functional sub teams (Global Regulatory Affairs Practice Teams and Technical & Supply Operations Practice Teams) and advises on best practices and/or supports Patient Solution Missions Team, as assigned by the GRA Practice Leadership Team.
- Responsible for strategy, planning, definition of content, preparation, review and approval of global CMC submissions for assigned projects/products to achieve timely approvals to meet business needs.
- Ensure that the global CMC regulatory strategy for assigned projects/products is consistent with the GRA Practice, TO Practice Teams and Patient Solutions Team missions, goals and objectives and meets HA requirements.
- Identify supporting CMC documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
- Accountable for writing and approval of CMC sections for submissions (i.e. for briefing documents, clinical trial applications, registrations, post-approval submissions, PIPs) and responses to health authority questions in line with agreed global regulatory strategy, and within agreed timelines.
- Ensure effective communication of CMC regulatory strategy, risks, and overall plans to GRA Practice Teams, TSO Practice Teams and PVU through the PVU-GRL.
- Highlight and proactively communicates anticipated and ongoing critical issues throughout the product life-cycle in a timely manner to key stakeholders (including TSO Practice Teams, GRA Practice Teams, PVU through the PVU GRL and the appropriate management level in the TSO Practice), as appropriate.
- Lead the preparation of the CMC SWOT analysis or regulatory risk capture document (i.e. global dossier risk analysis and mitigation/resolution strategies) and coordinates the associated RA CMC challenge session.
- Facilitate capture and communication (within and outside of GRA) of CMC lessons learned from major submissions for assigned projects/products.
- Responsible for all CMC related HA interactions, including negotiation and satisfactory resolution of CMC issues to facilitate CMC approvals in all regions.
- Lead cross-functional teams responsible for the preparation of responses to HA CMC questions for assigned projects/products.
- Monitor and reacts as appropriate to changes in the CMC regulatory environment in all regions for assigned projects/products to support and advise TSO Practice Teams and PVU.
- Provide regulatory affairs CMC leadership on TSO Practice Teams, GRA Practice Teams and PVU by establishing and maintaining a single point contact on regulatory CMC matters for assigned projects/products.
- Establish and maintains modes of effective communication and collaboration within GRA, TSO, CoEs.
- Establish regular lines of communication within CoE and across products, including frequent meetings with direct reports.
- Accountable for the coordination and overall approval (all regions) of regulatory assessments for CMC changes and creation of entries and updates in the designated systems (Trackwise, UPILOT, etc.) within defined timelines.
- Accountable/responsible for the roles and functions of the Regulatory CMC Scientist (if appropriate) for the geographical region in which the Global Regulatory CMC Scientist role is located.
- Represent GRA CMC on due diligence and divestment teams as assigned by the GRA Practice Leadership Team.
- Lead or provide input to GRA Practice initiatives and cross functional work streams as assigned by the GRA Practice Leadership Team.
- Lead or provide input to external industry organisations (e.g. EBE, CASSS, PDA etc.) on CMC matters
- CMC Biologics experience required.
- Module III authoring experience also required.
- Degree in any life sciences.
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