Deputy Manager/ Manager- Regulatory Affairs (India Market)

Aurigene Oncology Limited. (a Dr. Reddy's Subsidiary)

7 - 10 years

13 - 22 Lacs

bengaluru

Posted:2 days ago| Platform:

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Skills Required

dcgi regulatory affairs nda global regulatory strategies ind

Work Mode

Work from Office

Job Type

Full Time

Job Description

Preferred candidate profile

Degree in Life Science or related discipline required. Higher degree preferred (PharmD, M. Pharm, MSc, PhD, MBA).
7- 10 years of Experience in developing and delivering global regulatory strategies for product development and approval
Working experience IND and NDA filing of NCE products at global regulatory stage would be preferred
Strong exposure with India Market

Role & responsibilities

The candidate will represent the company with domestic and international regulatory authorities and business partners.
The candidate will be responsible for formulating global regulatory strategy for all the projects and will present it to relevant internal and external stakeholders.
The candidate will identify and assess regulatory risks associated with product filing. The candidate will define strategies to mitigate the risks.
The candidate will provide regulatory guidance to company personnel throughout the research and development process.
The candidate will set strategic direction and lead global regulatory submission process, including NOC & test license, marketing applications and core briefing packages.
The candidate will advise on global CTA / IND submission strategy.
The candidate will monitor and analyse appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.
The candidate will work closely with cross functional teams to prepare IND/NDA dossiers and regulatory response.

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