REGULATORY CLINICAL STRATEGY SUBMISSIONS jobs in UNITED KINGDOM, United Kingdom #4

and regulatory submissions for small molecule drug substance projects. Accountabilities As an expert in CMC project leadership... of Chemical Development supporting project delivery. Leading understanding and strategy for regulatory changes and challenges...

operations team. By working cross functionally with our clinical operations, medical and regulatory submissions teams...Job Summary We are currently seeking a Feasibility Coordinator, who will be a member of our global clinical...

safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA) with the GSP... regulations Clinical Development (Early and/or Late Phase) Post-Marketing surveillance MAA/BLA Submissions Periodic...

. Define regulatory strategy and plans for clearance / approval of Leica Biosystems technologies intended for cancer... and companion diagnostic submissions and acting on regulatory intelligence changes to ensure minimal impact to current and future...

technologies. Main Duties and Responsibilities: In this role, you'll be responsible for the Clinical Safety strategy...) and renewal documentation submitted to regulatory agencies and the patient safety contribution to global regulatory submissions...

regulatory submissions, and approval. Develop clear, prospective Go/No-Go decision points and continually validates the...(s) including a medical, regulatory, (CMC) Chemistry, Manufacturing, and Controls, research, operations, commercial, finance...

for all clinical submission documents of assigned drug projects Maintains current knowledge on all regulatory agency medical review... support of regulatory submissions globally (ie multiple regions). This position requires a Master’s degree in natural...

with biopharmaceutical processes, quality compliance, process development/qualification, control strategy and regulatory submissions... Lentiviral Vector (LV), Retroviral Vector (RV) and Adeno-Associated Viral Vector (AAV) production for early-phase clinical trials...

into regulatory submissions and Health Technology Assessments (HTAs) Assist Medical Information and Global Product Safety... as requested, including out of hour Input and leadership in developing the Regulatory strategy for portfolio in conjunction...

, corporate, property, regulatory, employment and litigation (commercial and clinical negligence) legal advice. Bevan Brittan... and respond to market and legal/regulatory changes within your MFGs Creating compelling marketing campaigns to promote...

regulatory leads (GRL) and UK cross functional stakeholders, advise on clinical trial strategy... This is what you will do: This position is responsible for development and implementation of the UK and Ireland regulatory strategy and activities...

submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent... with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience...

submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent... with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience...

submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent... with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience...

submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent... with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience...

submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent... with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience...

clinical safety assessments and regulatory reports/submissions involving safety information. Experience working with vendor... close collaboration with the safety vendor to ensure appropriate case processing. Contribute to regulatory authority submissions...