DRIVING A PEOPLE FOCUSED CULTURE

Ensure effective organization, leadership,
talent management and recruitment

Searchable Database

///Searchable Database

Searchable Database

Experience in Regulatory Affairs of US mkt. Review, compilation and submission of NDAs/ANDAs as per the FDA check list. Review, compilation and submission of Annual reports and post approval changes such as CBE, CBE 30 and PAS (Prior Approval supplements).

Years of Experience 6-10 years

Education Qualification for the position B.Pharma/M.Pharma


Hands on exp in Regulatory Affairs-Europe Market. Should have good exp in Module 3-Quality Part. Job role includes Filings, handling query responses, variations, Renewals and should have whole product life cycle Management.

Years of Experience 6-10 years

Education Qualification for the position B.Pharma/M.Pharma


Person having experience in Regulatory Affairs in Nasal Dosage form-US Market is suitable for this position.

Years of Experience 5 to 8 years

Education Qualification for the position B.Pharma/M.Pharma


2-3 yrs experience in eCTD and SPL Publishing.

Years of Experience 2-3 years

Education Qualification for the position Any Degree/DCCP


Formulation Development and Optimization of Injectable Formulations. Execution of Scale Up and Exhibit Batches. Preparation of Technology Transfer Documents. Preparation of Product Development Reports. Handling of Investigations of OOS. Handling of Regulatory Queries. Responsible for maintenance of assigned lab equipments and preparation of SOPs of the same.

Years of Experience 4-6 years

Education Qualification for the position M.Pharma


Formulation Development and Optimization of Solid Formulations. Handling of Regulatory Queries. Responsible for maintenance of assigned lab equipments.

Years of Experience 4-6 years

Education Qualification for the position M.Pharma


  • Harmonization of procedures and practices:
    • Draft / review / update Policies, Procedures related to Microbiology and Sterile Assurance.
    • Harmonize the Procedures related to Microbiology and Sterile Assurance across all units
  • Improving breadth and depth of Knowledge:
    • Identify and lead a network of Microbiology / Sterile Assurance Subject Matter Experts.
    • Act as a CQA Trainer for Microbiology and Sterile Assurance related Training programs.
  • Investigations and CAPA:
    • Act as CAPA coordinator for the CAPA related to Microbiology and Sterile Assurance.
    • Part of Investigations Team for Microbiology and Sterile related Investigations.
    • Act as Cross Functional Reviewer (CQA) for Microbiology and Sterile Assurance related changes, Non conformances, OOS etc, wherever applicable.
  • Act as Internal Auditor for Microbiology and Sterile Assurance area, wherever required.
  • Proactively assess risk, plan and execute audit deliverables. Work with sites to ensure their sterility assurance systems are properly prepared for external and internal compliance inspections.
  • Escalate Microbiology and Sterile Assurance related issues to Senior Management.

Years of Experience 22-25 years

Education Qualification for the position M.Pharm, M.Sc (Microbiology)


I. Planning:

Devising evidence based strategies for increasing the market and market share of assigned brands/therapies in the given region and ensuring effective implementation of the same.

To understand the therapy and develop assigned therapy portfolio by coordinating with RA to file new products and build appropriate therapy basket.
Improving brand & credibility of the company’s product in the international market via – Continuous product promotion campaigns along with monitoring and ensuring the implementation of the same

To help HOD to prepare the sales budget in the international market and define strategies to achieve the same in the stipulated time frame

To define strategies to explore new international markets and generating higher revenues from the international sales

II. Operation:

Proactively work towards developing quarterly promotional activities strategy and deliver within the stipulated time

To play a vital role in product improvement by providing information to Design / Development based on the market demand and competitors features.

Monitor the new product filing status in the assigned countries to ensure faster approvals/product registrations from the respective MOH

III. Co-ordination:

Co-ordinate with RA and have thorough understating of assigned countries regulatory aspects for future product identification and filing

Regularly liaise with the front end sales team/distributor to have complete knowledge of on ground activities and monitor the competition

Bringing market intelligence from international community back to the company to improve/fine-tune promotional activities to be more effective at the market place

Ensure rigorous follow-up with sales team for effective implementation of promotional activities planned to achieve the brand/therapy financial objectives

IV. Evaluation:

Incumbent to hold full responsibility and control on brands or therapy being handled

Continuous monitoring and measuring brand/therapy performance based on ROI

Evaluate/do a feasibility study on company product portfolio in order to fill the therapy gap at the market place

To prepare and analyze Key brands/Key countries performance on periodic basis

Key Deliverables:

Brand/therapy budgets

Product promotion

New product launches

Portfolio management

Years of Experience 22-25 years

Education Qualification for the position M.Pharm, M.Sc (Microbiology)


Production Planning & Scheduling

Years of Experience 8-10 years

Education Qualification for the position B.Pharm (MBA will be an added advantage)