Regulatory Affairs Manager (Mumbai)

Regulatory Affairs Manager (Mumbai)

31 Jul
|
G&L Scientific
|
Mumbai

31 Jul

G&L Scientific

Mumbai

G&L; have multiple positions available for Regulatory Affairs Manager. We are growing our teams on a global basis; there has never been a more exciting time to join us

Please note that we have vacancies in Barcelona, Belfast London and Mumbai. If you have the experience we require and can work in one of our offices, we want to hear from you

Do you want to help bring life-changing medicines to the world?

Are you passionate about science, strategy, and regulatory excellence? As a CMC Regulatory Manager, you’ll play a key role in ensuring that high-quality medicines continue to reach patients safely and efficiently across global markets.

You’ll sit at the intersection of science, manufacturing, and regulatory strategy, guiding post-approval activities and ensuring that every change to our products meets global regulatory standards.

If you enjoy solving complex problems, working across teams, and translating technical data into explicit regulatory strategies, this role is for you.

What You’ll Be Doing

? Lead Post-Approval Regulatory Strategies




Develop and implement regulatory strategies for post-approval CMC activities, including:
Variations
Renewals
Market expansions
Annual reports

Your work ensures our products continue to meet global regulatory expectations throughout their lifecycle.

? Evaluate Manufacturing and Quality Changes
Review change controls and assess how manufacturing or quality updates impact regulatory filings.
You’ll determine:
Regulatory classification of changes
Submission requirements
Global regulatory impact

? Review Critical Scientific Data
Collaborate with quality and manufacturing teams to review key reports such as:
Process validation studies
Stability studies
Analytical method validation

You’ll ensure all data supports regulatory submissions and meets compliance standards.
? Collaborate Across Teams
Work closely with colleagues across:
Manufacturing
Supply Chain
Quality Control
Quality Assurance
Global Regulatory teams

Your coordinatio

📌 Regulatory Affairs Manager (Mumbai)
🏢 G&L Scientific
📍 Mumbai

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