Senior Manager - Regulatory Affairs And Quality Assurance (Leading Pharma MNC)

India Pharma People
  • Pune
  • Confidential
  • 10-15 years
  • 04 Aug 2015

  • Quality Control - Product/ Process, Compliance/ Regulatory

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Job Purpose

Will be responsible for managing and controlling the Regulatory Affairs activities related to Imported Products and Locally Manufactured Products (i.e. Pharmaceutical, Medical Devices and Nutraceuticals / EN Products) marketed
Responsible for all regulatory, Quality compliance as NSO products.
Responsible for assuring HR policies and COC implementation within Department.

Main Accountabilities

Lead the local RA team members in the development of regulatory strategies to support the registration of new products, generic products, line extensions, major variations and lifecycle management.
Develop strong partnerships with in-country (e.g. Medical, Marketing, Supply Chain) and Therapeutic Area and Regional and Global Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, Generic Products, Medical Devices, EN Products, line extensions and life-cycle optimization.
Generate and meet customer expectations on regulatory support and deliverables.
Provide support to the Institutional Business / Tender Business with required documents e.g., Performance Certificate, No Objection Certificate, No Conviction Certificate, Manufacturing / Market Standing Certificate, Free Sale Certificate etc.
Responsible for assuring maintenance of approval status for all Imported Products.
Responsible for maintaining all regulatory documentation (licenses, certificates, etc) related to FKIPL marketed products in compliance with country regulations and applicable FKIPL procedures.

Co-ordinate with the relevant customers (internal/external) for trigger/support to regulatory/ Quality issues arising out of FKIPL Marketed products.
Co-ordinate and Follow-up with Global and Regional Regulatory for getting the Registration documents in time for New Products and Renewal products.
Review & Submission of the Dossiers/Application to MOH India for Registration & Re-Registration of Products and its Manufacturing sites for Pharmaceutical, Medical Devices and Nutraceuticals/EN Products.
Registration & Re-Registration of Products and Manufacturing sites of Fenwal India. Follow-up, Review & Submission of the Dossiers / Application to MOH India
Artwork and Labeling process / Compliance. Review and approval of the Artwork as per the current regulations & laws of D&C Act
Variation Filling & Periodic Safety Update Reports. Review and Submission of Variation Filling & Periodic Safety Update Reports to MOH India.
Obtaining of FDA Certificates for Tender Purpose. Review and submission of applications to FDA for obtaining of Certificates for Tender Purpose
Prepare and submit monthly RA update reports to AP and Global RA.
Interacting with DCGI / Local FDA / CDTL / FSSAI / Other Government Bodies for submission & obtaining of permissions and to short out any Regulatory issues.
Quality Management responsible Person
Handling of Market Complaints
Responsible for Batch Recall & withdrawal
Responsible for Release of Goods based on COA
Perform Audits (Internal & External)
Ensure the Quality Compliance
Responsible for Pharmaco-vigilance activities as NSO for Pharmaceuticals, Medical Devices and EN Products.
Review and Approval of Departmental SOPs.
To co-ordinate and facilitate the Testing of products from NABL Laboratories.
Management of Regulatory & QM Department. Involve in day to day activity of the RA & QM Department, management of the team and assigning the task to them on daily basis and ensuring the completion of the task in time. Approval of the departmental bills etc.
Approval of the attendance & leaves of team members. Providing guidance & support to the team in accomplishment of their task.
Preparation Regulatory Departmental Budget.

Experience and Qualifications

[Please detail any experience and qualification relevant for the job]
B. Pharm/ M. Pharm/ M.S (Pharma) with 10 -12 years of Experience in handling Domestic Regulatory Affairs and Quality Assurance from Reputed Pharmaceutical Companies.
Knowledge of D&C Acts and Rules and FSS Act and Rules is must.

Candidate from MNC back ground with thorough knowledge on systems, processes and compliances.
- Has adequate knowledge on pharmaceuticals and food articles and through in processes and systems
- Experience in dealing with FDA, FSSAI, DCGI and MoH
- Experience in working in a structured set up basis, i.e., regional reporting and corporate reporting

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India Pharma People