Sr Executive / Asst Mgr Plant RA (Regulatory Affairs)—-Injection

From 6 to 10 year(s) of experience
₹ 8,00,000 - 12,00,000 P.A.

Job Description

Roles and Responsibilities

  • Preparation, review, and compilation of Aseptic Package.
  • Review of Sterilization package.
  • Review of Media fill documents.
  • Evaluation of documents for submission to regulatory authorities.
  • Review of stability protocols and reports.
  • Review of analytical method validation protocols and reports.
  • Review of raw material, packaging material, finished product specifications, finished product stability specification and testing procedure.
  • Review and assessment of change control.
  • Compilation and submission of Post Approval Supplement viz. PAS, CBE-0, CBE-30.
  • Preparation, Review and Submission of Amendments and supplements for the assigned products
  • Preparation, Review and Submission of response to the Agency’s queries for the assigned products
  • Compilation and submission of Global Annual Report.
  • Review of Process Validation Protocol, hold time study protocols and Repots
  • Review of Product Development Report
  • Review of executed documents including executed BMR, Certificate of Analysis to ensure the compliance with regulatory requirement


Desired Candidate Profile

  •  Must have experience in PLANT RA functions
  • Comping and support for filling dossiers in injection formulation for US MARKET
  • Exposure to Compilation and submission of Post Approval Supplement viz. PAS, CBE-0, CBE-30.



Education

PG:M.Pharma in Any Specialization

Company Profile

HR Services

We, at HR Services are a group of experienced HR Professionals who have worked in leading corporates at various levels before setting up this venture. We firmly believe that the most distinguishing factor, which separates two organizations is, its people. The organizations, which have the right people are the ones which stand alone and are visible. Therefore, recruitment of the right and competent people is primary for the success of any organization. Finding right people is an all time effort and it is here that we come into picture & assist our client organizations to find the right people in minimum possible time. We are also committed to the jobseekers who place their CVs with us, by maintaining complete confidentiality about them
Company Info
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Recruiter Name:Surbhi SAndhu

Contact Company:HR Services

Telephone:9216118252

Reference Id:Plant RA

Website:http://jobs.hrsindia.co.in

Salary:

8,00,000 - 12,00,000 P.A.

Functional Area:

Research & Development

Role Category:

Pharmaceutical & Biotechnology

Role:

Medical Writer

Employment Type:

Full Time, Permanent