Senior General Manager

Principal task and Responsibilities:
•Lead the Formulation Development and tech transfer team and activities for regulated market in Cadila Pharmaceutical Limited (US and Europe, Canada).
•Work on contract manufacturing projects of regulated markets with collaboration to all stakeholders.
•Responsible for evaluation of received NPD request from BD team and prepare techno Business Case.
•Responsible for end to end development of all products those are under New development and
supplementary activities such as CRL, PAS, CBE30 for different regulated markets.
•Ensuring the team to follow all GLP, GMP compliances, SOP and guidelines.
Responsibilities:
•Strategic development of globally acceptable formulation, which should be cost effective, time
saving development.
•Development of QbD based high quality complex products for global markets (US & EU, AUS
Canada).
•Responsible for monitoring of key milestones those directly and indirectly linked with project success.
•Lead a team for development of robust formulation and process through optimization and scale up
studies well before start of validation batches.
•Timely do external collaboration with Contract development organizations, contract-
manufacturing organizations, and clinical research organizations to avail their facilities to complete
defined activities well within the timeline of each project.
•Explore knowledge of Design Expert software and other to all team members
•Actively support to technology transfer and production team (GMP area) for trouble shooting
during scale up, exhibit batches and post approval batches.

• Organize project progress meetings with all stakeholders to understand technical criticality as well

as update of all projects (Stage Gate Meetings).
•Address post-filling queries raised by Regulatory body well before the timeline.
•Actively discuss with clinical team about planning of clinical studies and its outcome for next line
of action.
•Actively discuss with team leads and members about product complexities (which include IP,
regulatory, Bioequivalence & formulations) and work design around alternatives to guarantee early
product development and launch.
•To provide the technical support for commercial troubleshooting of products to technology
receiving and production team
•Technical and non-technical support to senior management such as CAPEX and OPEX
requirement.
•AlWays apply synergistic approach to boost intra and inter department team leads. members, and
other cross-functional team members.

• Always make sound leadership qualities along vith strong decision-making power help

organization to take calculate risk, which not only save time but also cost of company.
•Arrange several internal and external trainings for better knowledge updation of all team members.
•Review and approve documents like SOP, Sampling plan and tech transfer documents, stability
study plan, Process validation protocol and Report timely.
•Provides documentation for the support of submissions. Performs technical review of product
development report, plant CMC section of an ANDA/ANDA Supplement or other regulatory
agency documents prior to forwarding to the Regulatory Affairs Department for inclusion in the
ANDA/ANDA supplement submission.
•Ensures adherence to cGMP requirements, Guidelines, SOPs.