James Cooper Email & Phone Number

United Kingdom

Sandwich, Kent

• Accountable for supporting initial and post approval submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets including HA query management.
• Apply knowledge and interpretation of regulatory requirements to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.
• Build local relationships and ensure communication/clarity of regulatory timelines and strategy.
• Ensure transparency and excellence in evaluation, definition and execution of regulatory strategies.
• Ensure dossiers are produced and dispatched to their defined filing plan, and are submission ready.

Sandwich, Kent

• JSC Pharma Services- ProClinicalContractor Umbrella- ProClinical
• Support EAEU dossier harmonisation activities in alignment and partnership with key stakeholders to ensure submission ready dossiers.
• Closely collaborate with EAEU regional regulatory hub strategist to ensure alignment with any ongoing regulatory activities across the respective countries.
• Actively manage and track project timelines and deliverables.
• Support planning and monitoring activities, update timelines and communicate changes to relevant partners.
• Liaise with manufacturing sites for obtaining supporting documents as needed.

Sandwich, Kent

• JSC Pharma Services- ProClinical
• Using VBA programming language, design clear and easy to use tools to import, display, calculate or manipulate large volumes of data. Where required allow for dynamic updates, for continued data addition.
• Design and produce monthly metrics for planning and monitoring in North America, South America, Europe, Africa, Asia and Australia for presentation cross functionally.
• Produce renewal compliance and planning cycle reviews, analyse and trend data in numerical and graphical formats with commentary for wider presentation of data.
• Utilise user activity data to determine usage patterns through time and identify any correlations between work misalignment and user activity to encourage adoption of newer systems/practices.
• Utilise tools for updating database with corrected information received from multiple stakeholders in bulk updates to assure database is accurate and aligned with business planning.

Sandwich, Kent

• Mylan Dublin Respiratory
• Product expert supporting validation, analytical development, process development and product development.
• Manage technical risks and identify opportunities to reduce product variability.
• Address analytical and product investigations to support batch release to the market.
• Data analytics trending of product critical quality attributes.
• Support method development, improvements and technical transfers.

Sandwich, Kent

• SRG Recruitment
• Carry out all analytical activities required to deliver new respiratory products to clinical studies and commercialization.
• Execute experiments to generate scientific understanding in development of analytical methods, formulations and processes.
• Perform analyses related to clinical supplies, stability and process scale up.
• Process data; identify aberrant or suspect results and investigate.
• Maintain laboratory documentation in accordance with cGMP documentation practices.

Sandwich, Kent

• Synergy Recruitment Solutions
• Organise documentation and data related inhalation product testing being conducted within and external to Mylan.
• Understand scientific data presented in spreadsheets, graphs, charts, and tables and confidently render raw scientific data into graphical formats.
• Create and maintain paper and electronic records containing business sensative data ensuring accuracy, security, and availability for broader communication.
• Carry about planned work necessary to provide and support project milestones for inhaled drug product development, working both independently and as part of a team.
• Communicate progress to immediate supervisor, appropriate colleagues and higher management informally and formally.

Sandwich, Kent

• Morgan Jones Ltd
• Follow COSHH, GMP, GLP and assure all appropriate training is up to date.
• Perform analytial testing including disintegration, hardness, appearance, several methods of water determination and work with HPLCs.
• Record all generated results and metadata in multiple IT based programs and controlled sheets.
• Work closely with investigations in order to improve methodology.
• Preform regular lab inspections to assure labs are suitable for efficient and accurate work.

Bachelor Of Science (B.S.), Bioscience, 2:1

Btech National Cetificate, Applied Science, Double Distinction

9 A-C Gcses And 3 National First Award Level 2S