Manager / Sr. Manager - API Regulatory Affairs Friday, 1 July 2016 No Comment

Job Summary

Locations:

Mumbai

Experience:

15 – 20 years

Keywords / Skills :

API Regulatory Affairs, API, Regulatory Affairs, HSE Guidelines, API regulatory

Function:

Pharmaceutical/ Biotechnology

Role:

Drug Regulatory Doctor

Industry:

• Bio Technology & Life Sciences
• Machinery/ Equipment Mfg.
• Pharmaceutical

Summary:

Experience: Minimum 15 years in API regulatory affairs department. To ensure API regulatory activities within Sandoz Private Limited as per stipulated time schedule.

Posted On:

1st Jul 2016

Job Ref code:

162644BR

A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement. Think what’s possible. Novartis and its associated companies are always looking for talented employees globally. We are engaged in advance preparation for potential position openings. Submit your CV/resume now to join our talent pool for the position described below. Please note that you are not applying for a current vacancy, but are submitting your CV/resume for consideration for future, possible opportunities. We look forward to receiving your information.

Major Accountabilities (Describe the main results of the job to be achieved )

1. To ensure API regulatory activities within Sandoz Private Limited as per stipulated time schedule.

2. To communicate with the customers and health authorities for API regulatory related ac-tivities.

3. To provide the regulatory support/advice/guidance to the concerned API sites/FDF sites/Development centres.

4. To assure the quality of DMF, its submission and its maintenance taking into considera-tion company business.

5. To co-ordinate and collaborate with QA/QC/Production/Development department of API sites and Formulation regulatory department.

6. To implement corporate HSE Guidelines in area of Operation Responsibility

7. Any other responsibility assigned by management with API regulatory department.

Key Performance Indicators (Indicate how performance will be measured: indicators, activities…)

1. Timely readiness of API regulatory documents / DMFs for new submissions /variations /updates .

2. To maintain high degree of quality of documents required for submission

3. Adequate deficiency responses within stipulated timelines.

4. Maintenance of submitted DMFs and updation on DMFs.

5. Compliance to KPIs of global regulatory department

Novartis is an Equal Opportunity Employer.

Minimum requirements Education: Graduation /Post graduation in Chemistry

Languages: English

Experience: Minimum 15 years in API regulatory affairs department:

API Regulatory AffairsAPIRegulatory AffairsHSE GuidelinesAPI regulatory

Novartis Healthcare Private Limited

To see all related Jobs. Please CLICK HERE

Manager / Sr. Manager - API Regulatory Affairs

PlacementFloor.com

PlacementFloor.com is a job portal for the upcoming and latest job opening in almost every sectors. The website automatically picks the recent openings and list them on priority.

Follow @ Twitter | Facebook | Google Plus

Tags: Biotechnology / medicine / Pharmaceutical / pharmacy