Amneal Pharmaceuticals, Ahmedabad, Gujarat is looking for experienced Regulatory Affairs professionals with strong expertise in Biologics/Biosimilars for global markets including USFDA and EMA. They are seeking professionals with strong regulatory expertise, strategic thinking, and the ability to work in a cross-functional environment. This role involves end-to-end regulatory ownership across development, submissions, and lifecycle management for large molecule products. What they are specifically looking for : - Hands-on experience in regulatory submissions (IND/BLA/ANDA, IMPD/MAA) -Strong understanding of CMC for biologics (cell line, upstream/downstream, analytical, validation, comparability) -Experience with biosimilar regulatory pathways (USFDA 351(k), EMA) -Ability to handle regulatory queries, deficiency responses, and global lifecycle activities -Exposure to sterile/injectable or specialty biologics is an added advantage Qualification Required: M.Ph...
Required Freshers or Experienced Technical Assistant Wet Lab for Multiple Locations - MSc in Biotechnology /Microbiology / Genetics / Molecular Biology- Salary - 2.75 LPA
Hystakanalytics is hiring freshers or Experienced Technical Assistant Wet Lab for multiple locations (Freshers Welcome)
They are seeking motivated and detail-oriented candidates to join their team as Technical Assistants.
This role offers an opportunity to contribute to innovative genomics-based diagnostic solutions and gain hands-on
Details are provided below
1. Designation :
2. Location: Aurangabad, Salem, Gujrat & Rajasthan (Salary - 2.75 LPA)
3. Experience: 0-6 Months (Freshers may apply)
4. Key Responsibilities
-Coordinate with diagnostic laboratory partners to ensure smooth functioning of infectious disease tests
-Support partners in implementing timely test upgrades and protocols
-Provide technical assistance to partner laboratories as required
-Maintain accurate and detailed documentation of activities
5. Eligibility Criteria:
MSc in Biotechnology /Microbiology / Genetics / Molecular Biology
-Knowledge or hands-on experience in DNA Extraction and RT-PCR
-Strong analytical and documentation skills
-Good oral and written communication skills
-Ability to prioritize and execute tasks efficiently
6. Work Requirements:
-Compulsory rotational shifts (Day /Night)
-6 days working with rotational week off
-Experience in the healthcare and life sciences industry.
7. How to Apply:
Interested candidates may apply or share their profiles at
careers@haystackanalytics.in
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