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Rusan Pharma
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Head Research and Development

Head Research and Development

Rusan Pharma

8 - 10 years

18 - 20 Lacs

ahmedabad

Posted:5 days ago| Platform:

Apply

Skills Required

analytical method development oral thin films transdermal patches r&d head regulated markets team handling r&d centre pharmaceutical r&d scientific leadership formulation development

Work Mode

Work from Office

Job Type

Full Time

Job Description

Position:

Department:

Provide
strategic leadership
for R&D activities related to
transdermal patches and oral thin films
in compliance with
cGMP and global regulatory requirements
.

Define and execute
product development strategy
, including
platform selection, lifecycle management, and pipeline planning
.

Oversee
formulation development, process optimization, scale-up, and technology transfer
to manufacturing.

Ensure implementation of
QbD, risk assessment, and design control principles
throughout product development.

Approve and review
development reports, protocols, and technical documentation
for
CTD/ANDA submissions
.

Guide and support
analytical method development, validation, IVRT/IVPT, stability studies, and extractables & leachables
programs.

Ensure compliance with
data integrity, documentation practices, and regulatory expectations
.

Lead responses to
regulatory queries, deficiency letters, and audit observations
related to R&D.

Drive
cross-functional collaboration
with QA, Manufacturing, Regulatory Affairs, Supply Chain, and Engineering.

Evaluate and qualify
raw materials, suppliers, and alternate sources
to ensure robustness and continuity.

Manage
R&D budgets, timelines, resources, and KPIs
to ensure on-time project delivery.

Lead, mentor, and develop
R&D scientists, managers, and technical teams
.

Promote
innovation, continuous improvement, and cost optimization
initiatives.

Support
post-approval changes, product troubleshooting, and lifecycle enhancements
.

Ensure alignment with
EHS requirements
, solvent management, and sustainability initiatives.

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