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Assistant Manager - Regulatory Affairs

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Exposure to plant regulatory activities, especially for US/ EU markets with hand full of experience on all dosage forms including solid orals and injectables.To collaborate with cross functional teams to provide appropriate regulatory strategies and to guide on critical regulatory requirements to meet the quality submissions and timely approvals.To participate in the deficiency meetings and review the pending deficiencies along with Cross-Functional Teams to ensure the adequacy and timely submission of responses.To coordinate and collaborate with core regulatory teams with respect to function related activities like Technical/regulatory related issues of pending deficiencies, Review status of the filed products at the agency and other function related activities for better collaboration.To review critical changes and approve the change controls and determine the impact on regulatory filing.To lead and/or participate in cross-functional project team discussions and work effectively to identify and assess regulatory risks. Discuss the regulatory risk and strategies with departmental seniors that mitigate risk and ensure its implementation.Enable the audits by acting as a SPOC, provide regulatory support/data to plant cross functional teams (CFT) for audits by the regulatory authorities / agencies.Involve and provide regulatory support to plant CFT regarding OOS / OOT / Other Product related issues / plant related activities.Training of plant personnel to impart Regulatory Awareness/Regulatory Updates.
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 6-10


Clinical Research | Quality Assurance/ Control | Regulatory Affairs
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