HomeRegulatory AffairsRegulatory Affairs (Non Orals) | Parenterals/Sterile | Alembic Pharmaceuticals | Hyderabad

Regulatory Affairs (Non Orals) | Parenterals/Sterile | Alembic Pharmaceuticals | Hyderabad


Alembic Pharmaceuticals Limited, with an established presence in the Indian pharma industry, has a proud, historical track record going back one hundred years. With a turnover in excess of Rs. 3000 crores today, Alembic Pharmaceuticals Limited is one of the leading API & Formulations manufacturing and marketing pharmaceutical company. We continue to enjoy leadership positions in antibiotics, anti-infective, anti-cough, and also have a significant worldwide presence in specialty therapeutic areas such as cardiology, neurology, diabetology, etc.

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We have newly setup plants of Oncology, General Injectable, and Dermaceuticals. Upcoming plans of General Oral Solid Dosage at Jarad, near Vadodara. Alembic is having manufacturing facilities at Vadodara, Panelav, Karkhadi, Jarod in Gujarat, and Domestic manufacturing of Formulations at Sikkim. Gujarat based facilities are approved by the US FDA, EDQM, TGA, MHRA, and MCC. Alembic Research Center at Vadodara (ARC) and AG Research Center at Hyderabad a world-class research organization provides a comprehensive range of services in the areas of synthetic chemistry, formulations, NDDS, Oncology as also preclinical pharmacology, bioequivalence / bio-analytical studies, etc. ARC & AG Research, designed to state-of-the-art GLP standards with more than 350 scientists working on the latest technology and systems. Our current employee strength is in excess of 8000 across the country. A continuously expanding organization, we invite dynamic, result-oriented competent personnel to join us across various functions.

Position: Regulatory Affairs for EU & Canada -Sterile/Parenteral (Non-OSD)

Location: Hyderabad, Telangana

Job Description:

  • Well versed with the module I, module IV and V requirements for above-specified geography(EU, Australia, Canada)
  • Hands-on experience of preferable for working in aforesaid modules.
  • Administrative and procedural understanding in aforesaid markets i.e. right from inception, pre-submission, post submission and post-approval considerations.
  • Ability to perform gap assessment from the US market to be extended to the EU / TGA / CA region.
  • Experience in Sterile Formulations preferred however if found exceptionally good, incumbent from the oral background can also be considered.

Qualification: B.Pharma, M.Pharma

Experience: 5-10 Years

Salary: Negotiable

Contact Details:

talent@alembic.co.in, corporate@alembic.co.in

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