Alembic Pharmaceuticals Looking For Clinical Affairs-F&D

Alembic Pharmaceuticals is looking to hire Clinical Affairs-F&D.Interested and eligible candidates can send their resume . The eligibility criteria as follows.

Vacancy details :

Job description:-.

• Evaluation and management of external / in-house BE center – contract service provider for BA/BE and Clinical studies.
• 2. To conduct literature search to gather the scientific information of the product for the BE strategy finalization.
• 3. Designing & review of protocol (for various dosage forms like IR, MR, Sublingual/ODT and Suppositories etc.) for various types of bioequivalence study like food effect study, steady state, partial replicate/replicate studies for Solid orals and adhesion & irritation studies for Transdermal products.
• 4. Review of protocols, reports and study related documents, maintaining the project files and records as per regulatory requirement like USFDA, MCC, EMEA, ANVISA and other regulatory authorities.
• 5. Well versed with regulatory requirement USFDA, EMEA, ANVISA, Health Canada, DCGI, CDSCO w.r.t BA/BE and clinical studies
• 6. Extensive experience with the conduct of bioanalytical and PK studies
• 7. Extensive knowledge with FDA, EMA, and ICH guidelines and extensive knowledge of good laboratory practices and good clinical practices
• 8. Extensive knowledge of Watson LIMS (or equivalent systems) and barcode application

How to Apply :  Click here for full details and Apply