Regulatory Sciences Associate job in karachi
Full time On-site @Pfizer posted 2 months ago in Administration , in Consultants , in Health Care ShortlistJob Detail
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Job ID 12289
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Experience Fresh
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Gender MaleFemaleTransgender
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Industry Health care
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Qualifications Medical Degree
Job Description
Job Responsibilities
- Registration Application Submissions
- Pricing Application Submissions
- Post-Approval Variation Submissions
- Query Responses to DRAP
- Renewal Submissions
- Support registration activities (pre- and post-approval, withdrawal) including but not limited to;
- Maintenance of Compliance Systems / Information
- Maintaining Internal Trackers
- Support Psychotropic Quota Applications
- Support Vaccines Lot Release Applications
- Maintains familiarity with company product ranges and ensuring compliance with regulations
Qualifications
Must-Have
- Pharm.D. Degree
- Good interpersonal, communication and negotiation skills
- Fluency in written and spoken English
- Good knowledge of electronic repositories and document management systems
- Excellent computer skills in Microsoft Office Suite, Adobe Acrobat etc
Nice-to-Have:
- Demonstrated experience in pharmaceutical industry
- Basic understanding of dossier preparation (CTD format)
- Prior knowledge of local regulatory environment and regulations
- Basic understanding of CMC
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