Job ID: 2749871511
Senior Executive - Regulatory Affairs - Delhi
Who we are
At Roche, 85,000 people across 150 countries are pushing back the frontiers
of healthcare. Working together, we’ve become one of the world’s leading
research-focused healthcare groups. Our success is built on innovation,
curiosity and diversity.
Roche Diagnostics India, with a sales turnover of INR 150 crores, nurtures an
open, flexible and challenging work environment, which allows for rapid career
progression. Favored by its geographic location in the heart of Europe, the
Basel area is one of the most dynamic economic regions in Switzerland — a great
place to live and work.
The Position
Roles and
Responsibilities
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1. Preparation
of regulatory documents e/g. DI, DII, DMF, PE Dossier, RTQ etc., with compilation
of dossier, review regulatory application &
submission of all required application pertain to Roche
Diagnostics with full
responsibility, accountability.
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2. Understanding &
interpretation of Law & the Local regulatory requirement and implementing
same in India submission with compliance for Roche Products.
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3. Responsibility for
close coordination & regular follow-up with the Regulatory Authority for
timely obtaining of all approvals.
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4. Coordination with
global regulatory team, local BA & other functions, required for regulatory
submissions at India FDA.
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5. Close monitoring of
any changes in local & global regulation's and communicating same within
the
department.
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6. Responsible for
regulatory activity with compliance and maintain reputation of the organization
before authorities.
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7. Respecting &
following all SOP / system implemented within the department and
organization.
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Who you are
You’re someone who wants to influence your own development. You’re looking
for a company where you have the opportunity to pursue your interests across
functions and geographies. Where a job title is not considered the final
definition of who you are, but the starting point.
Qualification - Graduate / Post Graduate in Bio-Chem / Molecular Biology /
Microbiology with Minimum - 4-5 years of experience in handling regulatory
documentation
Preferred - Post Graduate - with 5 yrs. experience
The next step is yours. To apply today, click on the "Apply online" button below.
Roche is an Equal Opportunity Employer
Apply online
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