Regulatory Manager - Pharma

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 kalpanagandhi62@yahoo.com

Kalpana Gandhi Chhatriwala
CorporateSearch
98200-53879
http://www.linkedin.com/in/kalpanagandhi62