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02/05 Ravi Kumar Battaram
Director at Ideal Placement & Consultants Pvt. Ltd.

Views:4811 Applications:47 Rec. Actions:Recruiter Actions:42

GM - Regulatory Affairs - Pharma (10-15 yrs)

Hyderabad/Secunderabad Job Code: 214440

- Liaison with Federal and State Regulatory Authorities for approval of all types of applications relating to clinical trials, licenses pertaining to imports, manufacturing, etc

- Registration strategy for new products in sync with business needs

- Registration of new products and clinical trial approvals

- Registration of Manufacturing Sites and Import Licences

- Maintenance of existing registrations / licenses

- Safety reporting

- CDL clearances

- Coordination with the Global Team

- Participation in interviews with the auditors during audit

- Providing valuable inputs in the interest of organization being a senior member of the Team

- Dossier Preparation and Life Cycle Management as per the statutory needs globally

- Should have experience in Life Sciences - Biotechnology or biochemistry or pharmacy (compulsory)

Preferably MBA

Team size 15 people reporting to him/her

Excellent communications and presentation skills, having exposure of communicating with foreign nationals

Good PR person to deal with local and central Drug authorities, co-ordinating with global inspecting authorities, global clients, auditors,

Should have experience in vaccines or sterile injectables (at least 5 years)

Presently should be heading regulatory affairs dept not less than 10 people

Soft skills:

- Good in change mgmt

- Decision making

- Transversal cooperation

- Result oriented

- Interpersonal relationship

- Leading teams and team players

- Communications and presentation skills at least 75% (Mgr has to present reports to foreign nationals as well)

- Should be from good university

- International exposure

- Software skills and exposure to latest technologies related to production activities

Call at 9849006750

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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