Qualification – Master’s/ Bachelor's degree in a relevant field (e.g., pharmaceutical sciences, life sciences). Degree in Business Administration/ PMP (Project Management Professional) certification is a plus.Job description – · Manage Marcan, Emcure BD and finance team for finalizing new R&D projects with Project Initiation Development Form (PIDF) signatures· Lead and track all R&D projects with signed PIDF for timely submission and approvals· Manage project material requirements with material management and vendor management teams· Manage activities required for all R&D projects ensure on time submissions and ensure communications to all stakeholders within these projects· Help align exhibit batches schedules with priorities· Manage flow of work between formulation and analytical groups· Support early cooperation between development, QA,RA and manufacturing teams and facilitate on time product launches· Manage CMOs for all in-license projects· Overseeing and executing various projects related to drug development, trial and exhibit batches, analytical method development and validations, preclinical, BE studies, regulatory submissions, in-licensing and product commercialization. · Must have worked with regulated markets likes US, EU. Experience in the Canada market will be desirable.· Responsible for ensuring that projects are completed on time, within budget, and in compliance with industry regulations and quality standards. · Proven experience in project management within the pharmaceutical industry. · Strong knowledge of pharmaceutical regulations and compliance standards.· Single point of contact for the status and details of any project which is his/her responsibility.· Responsible for monitoring the progress of a project versus the approval assumption and raising flags when things are off course. · Is also responsible for recommending stopping a project if the initial assumptions have changed so much that the ROI is compromised (or negative).· Collects fundamental project information such as ANDA#, ANDA holder, shelf life, strengths, RLD, NDCs, SKU, COGs, API supplier info, manufacturer, packager, batch size info and any other significant, relevant information.· § Depending upon project type (development, CBE, PAS, Launch), ensures all project activities are accounted for, confirms and understands with Emcure stakeholders regarding individual activity timelines and durations, maintains project Gantt chart.· Ensure business case, development/supply agreement, confidentiality agreement, vendor audit, quality agreement and pharmacovigilance agreement are in place prior to project initiation. And on a quarterly basis, ensure that the business case has not changed.· Communicate with Emcure cross functional teams to understand API, raw material, packaging material, tooling and analytical sample lead times and arrival dates. Responsible for raising RED FLAGS if a project is off track financially or timing wise.· Ensure business case, supply agreement, vendor audit, quality agreement and pharmacovigilance agreement are initiated/complete, or in progress.· Ensure NDCs are created, product artwork is approved, drug listing is completed.· Ensure batch size and COGs are confirmed.· Coordinate with marketing and supply chain teams for product forecast and POs, ensuring that a minimum of 3 months of Finished dosage inventory is purchased. Skills: · Good strategic and analytical mindset. Good command on written and spoken English. · Good knowledge of ICH guidelines and GMP environment.· Specifically worked with pharmaceutical manufacturing processes like formulations. · Ability to work effectively in a fast-paced and highly regulated environment.
