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Venus Remedies (VRL)
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Drug Regulatory Affairs- Herbal Product

Drug Regulatory Affairs- Herbal Product

Venus Remedies (VRL)

6 - 11 years

6 - 14 Lacs

panchkula

Posted:None| Platform:

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Skills Required

ayurveda herbal product nutraceuticals drug regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

We are seeking a skilled and detail-oriented Drug Regulatory Affairs Manager to lead and manage regulatory activities for our natural product portfolio across both regulated and non-regulated markets. The ideal candidate will have expertise in drug regulatory requirements, with a strong focus on natural products, ensuring compliance, timely submissions, and strategic regulatory planning to support product lifecycle management.

Key Responsibilities:

Lead and oversee regulatory affairs activities related to natural product-based drugs for both regulated and non-regulated markets.
Develop and implement regulatory strategies and submission plans to ensure timely approvals and market access.
Prepare, review, and submit regulatory dossiers including INDs, NDAs, ANDAs, CTDs, and variations for natural products.
Monitor and interpret regulatory guidelines, changes, and industry trends specific to natural products, ensuring compliance and proactive adaptation.
Collaborate cross-functionally with R&D, Quality, Manufacturing, Marketing, and Legal teams to align regulatory requirements and support product development.
Manage communication and liaison with regulatory agencies and external partners, ensuring timely responses and successful negotiations.
Maintain regulatory documentation, databases, and ensure audit readiness for regulatory inspections.
Provide training and guidance to internal teams on regulatory requirements and updates related to natural products.
Support post-approval regulatory activities including labeling, renewals, and reporting requirements.
Identify and mitigate regulatory risks throughout the product lifecycle.

Preferred candidate profile

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Venus Remedies (VRL)

Pharmaceuticals

Gurgaon

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Drug Regulatory Affairs- Herbal Product