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Regulatory Affairs Specialist

2 months ago


Mumbai, India Ashish Life Science Pvt Limited Full time

Job Location: Andheri West

Company profile:

Established in 1975, Ashish Life Science Pvt. Ltd. is a member of the "Ashish Group of Industries." We commenced our pharmaceutical manufacturing operations in 2002. Since our inception, we have been dedicated to serving customers worldwide by providing veterinary products, regardless of the order size. Over the years, we have earned a reputation for reliability and trustworthiness with our clients. Our commitment to personalized service, strong working relationships, and customer satisfaction extends globally.

Our team comprises dedicated professionals who value learning, empathy, and innovation. We demonstrate high diligence in every aspect of our operations. Our adherence to quality, implementation of best-in-class manufacturing practices, investment in infrastructure, highest laboratory certifications, and exceptional service standards have allowed us to establish enduring relationships worldwide.

We are a frontrunner in veterinary pharmaceuticals, serving over 65 countries worldwide. We've earned the distinction of being India's largest exporter of veterinary drugs, ensuring animal health solutions reach a global audience.

Our dedication to customer service extends beyond borders. We have a dedicated team in Africa, along with a network of 7 regional offices around the world, allowing us to provide direct support to our customers.

With a team exceeding 30 veterinarians worldwide, we possess the expertise to deliver on our core mission: improving animal health and wellbeing through innovative solutions. We empower farmers to provide better care for their animals.

For more information

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Job Responsibilities:

  • Preparation of dossiers in CTD, ACTD & country specific format, renewal and variation applications for market based on region specific requirements.
  • Handling registration Queries.
  • Evaluation of technical documents for registration.
  • Good knowledge of CTD and ACTD formats.
  • Check and review of the artworks required for registration.
  • Coordinating with QA ,QC and production for registration documents and samples
  • Application of legal documents required for registration purpose.
  • Arranging for samples for country.
  • Maintain registration updates about all registration submission and approvals.