Manager-Regulatory Affairs

2COMS Consulting Pvt. Ltd.
  • Gurgaon
  • Confidential
  • 6-10 years
  • Views
  • 04 Jan 2017

  • Compliance/ Regulatory

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

1.To review the manufacturing end data of Exhibit Batches of New APIs as well as Post-approval changes of Existing APIs taken for regulatory adequacy & provide to corporate DRA in a timely manner for various regulatory and customer filings and queries in a timely manner.
2.To review Change Controls pertaining to process, quality & equipment related matters and Q-Info extensions of Key Raw Materials/Key Reactants of various APIs manufacture.
3.To ensure Regulatory Compliance of Exhibit Batches of APIs to be filed in DMF, ANDA batches, DMF Update / Amendment / Variation batches .
4.To ensure data generation of API / Intermediates in line with approved protocol requirements & provides regulatory support during regulatory audits at various manufacturing

Dimension:
1.To provide manufacturing end data of APIs to Corporate DRA for regulatory Filings in US, EU, Canada, Japan & Emerging Markets and APIs for Annual reportable Changes & post-approval changes for filing Amendments/Variations in US, EU, Canada, Japan & EM
2.Day to day regulatory support to API Manufacturing for review/approval of Change-Control for ensuring Regulatory Compliance
3.Regulatory Compliance reviews for API / Intermediates exhibit Batches, if required
4.To assist API Manufacturing during regulatory audits conducted by various regulatory agencies.
Delegation of Responsibility: In the absence of the job holder, the responsibilities will be delegated to a colleague at the same or higher level.

Desired Candidate Profile
Candidates should be working in API.
Dealing into Regulatory Affairs.


Competencies/Skill sets for this job

Regulatory Compliance Api Manufacturing Regulatory Affairs

Job Posted By

2coms
Manager

About Organisation

2COMS Consulting Pvt. Ltd.