Biocon hiring for Regulatory Affairs / Technology Transfer / Packaging Engineer || Apply Now - Pharma Jobs and Pharma Walk-in interviews | Pharmawalks
  

Monday, January 6, 2020

Biocon hiring for Regulatory Affairs / Technology Transfer / Packaging Engineer || Apply Now

Biocon hiring for Regulatory Affairs / Technology Transfer / Packaging Engineer || Apply Now
Greetings from Biocon..!!!
We are hiring for below mentioned positions 


Regulatory Affairs - Biologics
Qualification
M.Sc / M.Tech (Biotechnology) /
PhD (Life Science/Biotechnology)
Experience: 4 - 8 years 
Job Description:
๐Ÿ‘‰ Write & review regulatory submissions like IND, IMPD, MAA, NDA, DMF and documents for regulatory advices.
๐Ÿ‘‰ Guidance to cross functional teams on regulatory expectations for US, EU, Japan and major markets.
๐Ÿ‘‰ Ensuring regulatory compliance in cross functional teams and managing cross functional team deliverables.
๐Ÿ‘‰ Review of CMC, clinical, bioanalytical development related documents & ensure compliance to CTD requirements.


Regulatory Affairs - Formulations
Qualification: M.Sc / M.Pharm
Experience: 3 - 6 Years
Job Description:
๐Ÿ‘‰ Compilation of eCTD format & review of dossier (ANDA, MAA, ANDS) including technical data package.

๐Ÿ‘‰  of Batch records, specification, art work and packaging material, analytical method validation documents, development documents, PDR & labeling.
๐Ÿ‘‰ with R&D in evaluating and finalizing QbD elements at different stages of product development.
Write high quality deficiency response to regulatory authorities.


Technology Transfer - Formulations
Qualification: M.Pharm - Pharmaceutics
Experience: 7 - 10 Years
Job Description:
๐Ÿ‘‰ Preparation on technology transfer strategy with timelines, gap analysis, technology dossier and execution plan for both Potent & Non-potent compounds. 
๐Ÿ‘‰ QbD based optimization of process by following DOE designs to ensure robust manufacturing process before transfer to site.
๐Ÿ‘‰ Monitoring execution of the TT demo batches, optimization batches & registration batches for USA & EU markets. 
๐Ÿ‘‰ Experience of handling both Solid oral as well parenteral products would be an added advantage.


Packaging Engineer - Formulations
Qualification: M.Pharm - Pharmaceutics
Experience: 6 - 10 Years
Job Description:
๐Ÿ‘‰ Developing multifunctional, cost effective, eco-friendly packaging solutions to meet specific needs and requirements.

๐Ÿ‘‰ Working on devices i.e. auto-injector, Pens for Cartridges for US, EU & other major markets.
๐Ÿ‘‰ Development of change part for solid oral dosage form (blisters and strips) as primary & secondary packs for injectable products like Vial, Ampoule and PFS.

Interested candidates can send thier updated resume to 
 ruchi.panjwani@biocon.com

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