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05/10 Kalpana Gandhi
Owner at Corporate Search

Views:655 Applications:4 Rec. Actions:Recruiter Actions:1

Regulatory Manager - Pharma (5-8 yrs)

Delhi/NCR/Mumbai Job Code: 72546

Regulatory Manager Mncs Pharma , Medical Devices & Technology

Corporate Search is one of India's leading Executive Search and Talent hunt firm with a specialized focus in the multiple sectors

We have the following requirement -

Regulatory Manager

Scope of role

- Ensure business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance. Also ensure continuous implementation of the Quality Management System in India.

Qualificatio Required:of potential candidates

- Bachelors/Masters in Pharmacy/Technology/ Biomedical Science/Engineering/Biomedical Engineering/ Biotech/ Biochemistry/ Pharmacology/Organic Chemistry/Life Sciences.

- Post Graduate Diploma in Business Management is not mandatory, but is desirable.

- Required Skills 5-8 years of experience in Regulatory Affairs/Quality Assurance. Experience in working with Central and State Drug Control Authorities for Drugs, Pharmaceutical Formulations, Medical Devices etc.

- Experience in a medical device environment; knowledge of Quality System Regulations (QSR) preferred.

- 3-5 years of experience handling product customer complaints.

Other Preferred Skills

- Strong communication and inter-personal skills, ability to work under pressure and ambiguity, hardworking, diligent, self- starter, quick learner.

- Thorough knowledge of D&C act and Rules and regulatory guidelines. Knowledge of DCGI regulatory processes for Drugs and Medical Devices, WHO-GMP certification/ Schedule MIII.

- Basic understanding of USFDA and EU regulatory requirements for Medical Devices.

- Ability to understand and apply concepts of QA/RA

- Ability to learn technical product design and operation of medical devices

- Excellent analytical decision making and problem solving skills

- Partner with individuals to build relationships with business and customers

- Computer literacy skills in programs that are applicable to role

- Ability to define problems independently, to collect data, to establish facts and draw conclusions.

Relevant candidates interested may apply to with a brief introduction and compensation drawn

Please send your resume to

Kalpana Gandhi Chhatriwala

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Women-friendly workplace:

Maternity and Paternity Benefits

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