Sr Executive / Asst Mgr 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

Maintaining product life cycle by filing post approval changes (CBE, CBE-30, Prior Approval Supplement (PAS) and Annual Reports.
Providing response to deficiencies received from regulatory authority for Product life cycle changes.
Review of Pre-ANDA documents
eview of technical documents like BMR, BPR for regulatory compliance


Desired Candidate Profile



  • Exposure to Compilation and submission of Post Approval Supplement viz. PAS, CBE-0, CBE-30.
  • Must have worked for US market
  • Must have exposure to Sterile formulation products



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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View Contact Details+

Recruiter Name:Surbhi SAndhu

Contact Company:HR Services

Telephone:9216118252

Reference Id:RA Injection

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