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Home / Job / Immediate Openings in Regulatory Affairs / Purchase (OSD / Parenteral Formulation) @ Chennai & Bangalore

Immediate Openings in Regulatory Affairs / Purchase (OSD / Parenteral Formulation) @ Chennai & Bangalore

Immediate Openings in Regulatory Affairs / Purchase (OSD / Parenteral Formulation) @ Chennai & Bangalore

Purchase at Chennai

Experience: 5 to 8 years (OSD /Parenteral formulation)

Industry Type: Pharma company

Send CV to Srinipharmacy@gmail.com

RA at Chennai (RoW Market) OSD formulation unit

Experience: 1 to 7 years (ROW Market)

Send cv to Srinipharmacy@gmail.com

Contact 9535307023

RA – Manager / AGM /DGM- (1 Post) ( 15-30 Lac)

RA- Asst Mang / Sr.Exe / Ex- (3 Posts) ( 5-10 Lacs)

(TDS/ODF formulations). Bangalore

Job Description:

 Submission of ANDA(s) / Dossier.

Compilation and Review of ANDA as per USFDA / EU / ROW requirements.

to respond the queries raised by USFDA / EU / ROW in stipulated time frame.

Annual reports as per USFDA / EU / ROW requirements.

Compilation and review of clinical trial applications to support skin irritation, sensitization and adhesion study.

Managing multiple projects and drive regulatory submissions in a cross-functional environment.

Creation of GDUFA facility and ANDA payments cover sheets.etc

(Bangalore location)

Send cv to srinipharmacy@gmail.com

Contact: 9535307023

Apply for this position

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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