Sr Executive - Regulatory API
kk consulting services
Mumbai | Thane, INDIA
3h ago
source : TimesJobs

Sr Executive - Regulatory API KK Consulting Services Opening 1 Nos. Job ID 6894 Employment Type Full Time Reference Work Experience 4.

0 Year(s) To 5.0 Year(s) CTC Salary 4.50 LPA TO 5.00 LPA Function Pharma / Biotech / Healthcare / Medical / R&D Industry Pharma / Biotech / Clinical Research Qualification B.

Pharma - Pharmacy; B.Sc - Bio-Chemistry; M.Pharma - Pharmacy Location Mumbai Job Description Job description for API Regulatory Preparation, review and submission of Drug Master Files / CEP in eCTD format for the regions US, EU through ESG and CESP.

Life cycle management of the Drug Master Files (Amendments, Annual Reports, CEP updates). Preparation, review and submission of Applicant's Part DMF (Open Part DMF) and Technical data package to customers.

Handling of DMF deficiencies received from regulatory agencies with coordination of the cross functional teams within the stipulated time.

Handling of customer queries related to DMF / Product. Preparation, review and submission of Letter of authorization / Letter of access (LoA) to regulatory authorities & customers.

Review of changes for the DMF filed products w.r.t regulatory point of view. Supporting the regulatory / customer audits.

Hands on experience on eCTD guide lines and update with the current guide lines. Experience 4-5 years Job location Thane Keyskills Regulatory Affair Documentation Pharmaceutical Api Company Profile Many people view a job change as a way of promoting themselves to a better position.

And in most cases, we at KK Consulting services would agree. However, you should always be sure that your new job offers you the means to satisfy your values.

While there's no denying the strategic virtues of selective job changing for the purpose of career leverage, you want to make sure the path you take will lead you where you really want to go and want to achieve in your life.

At KK Consulting services, the "right" job is one in which your values are being satisfied most effectively. If career growth and advancement are your primary goals, and they're represented by how much you earn, then the job that pays the most money is the "better" job.

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