Astrazeneca

Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.

Ensure team members are trained and competent in all delivery areas. Assist the team during high work volumes by completing LTO accountabilities. Apply scientific knowledge to create compelling medical content and communications.

Developing India-specific Artwork, Support to Regulatory dossier preparation and submissions like New drug applications, Site registration, Clinical trials and Import licence. Managing Registration samples right from dispatch of samples till the report.

Plan, execute & ensure timely submission of various applications when assigned including but not limited to only these: test license application, HAQ response submission, CT updates and notification submission e.g. IB amendment, site closure, site addition, EC approval submission etc.

Engage in peer-to-peer level dialogue with key customers and deliver appropriate clinical, scientific content through utilizing the correct channel mix, which will differentiate AstraZeneca products from those of other companies.

Ensures that direct reports have development and training plans, according to IDP process. Coaches the direct reports on a regular basis, and plans, organizes coaching with external providers if needed.

Support DM Delivery Leads to maintain CDM specified systems and types of deliverables, milestone achievements, risks and mitigations and data transfer agreements, and other study administrative needs.

The Regulatory Affairs Manager II is fully proficient in applying established standards and performs regulatory affairs management for moderately to highly complex international market submissions in all regions with minimal coaching. They are expected to facilitate strategic input, provide proactive contribution to submission planning, identify areas for continuous improvement, and lead cross-functional activities. They participate in the continuous improvement of processes and tools, systems.