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Walk In- Regulatory Affairs -drug Finished Formulations (ghatkopar E)

3 - 8 yrs

Time and Venue

1st June , 11 AM onwards

Titan Laboratories PVT. LTD. ,A/01-GF & A/101, Plot NO-120, 60 Feet rd Anand Bhavan, Spectrum Building,R. B. Mehta Marg,Ghatkopar East, Mumbai-400077, India Tel: +91-22-67857000, Fax: +91-22-67857070

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Not Disclosed by Recruiter Openings: 5 Posted 28 days ago Job Applicants: 98 Job Views: 750

Job Description

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    Time : 11:00 am to 4:00 pm

    Executive to Asst. Manager 

    Experience: 3 -10 years


     EU/CIS/ South East Asia/-GMP Manufactures of Sustained and Modified Release Pellets, DC Granules, Taste Mask Granules, Tablets and Capsules.

    Job Description.
    1) Dossier Preparation ACTD/CTD/Country Specific for domestic or international market (CIS , Franko West Africa & South Est Asia market) &to ensure error free & timely submissions as per marketing Dept. timeline.
    ) To evaluate & respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query.
    3) Dossier Checking of subordinates in ACTD/CTD/Country Specific format
    4) To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements
    5) To Co-ordinate /to visit with respective dept. in HO /Plant /ADL/R&D for documents & samples required for dossier / registration purpose.
    6) Co-ordination with API /PM vendors to resolve technical quires w.r.t. regulatory requirements
    7) Artwork Checking & development for registration and commercial purpose as per regulatory requirement
    8) To Maintain & Update all documentation & dossier record; to update registration status.
    1. Good Communication Skills
    2. Analytical Skills
    3. Good in MS Office

Salary: Not Disclosed by Recruiter

Industry: Pharma, Biotech, Clinical Research

Functional Area: Legal , Regulatory , Intellectual Property

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Employment Type: Permanent Job, Full Time


Desired Candidate Profile

    Please refer to the Job description above


UG: B.Pharma - Pharmacy

PG:M.Pharma - Pharmacy

Company Profile:

Titan Laboratories Pvt. Ltd

Titan Laboratories Pvt.Ltd. is the one of select few Company in india with dedicated state of art WHO GMP facility for producing high quality Sustained and Modified Release Pellets, DC Granules& Taste Masked Granules. The plant is located in green belt of mahad industrial zone about 180Kms from mumbai. It is strategically located on well connected Mumbai-Goa Highway.

Titan is a speciality Pharmaceutical company engaged in developing and manufacturing Sustained and Modified Release Pellets using Innovative Drug Delivery Technologies Utilizing some of best and latest processing machineries like Fluid Bed Processor with inherent built in rotary unit coupled with Top And Bottom Spray arrangement. This is essential to achieve uniformity and efficiency in layering and/ coating process which in turn will ensure in consistent release characteristics. Facility of Extruder & spheronizer is also available for effective pelletizing selectivity depending upon dose requirements of actives.
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Walkin Interview

1st June 11 AM

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Job Posted by

Shivali Khanna Company Recruiter Titan Laboratories Pvt. Ltd Mumbai

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