Job DetailsJob Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072Position Type: Internship Assist in the preparation and submission of regulatory documents to health authorities for product registrations…
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Skills: cGMP Compliance, Deviation Investigation, CAPA, Validation and Qualification, Root Cause Analysis
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Skills: Commissioning and Qualification, Statistical Analysis, Design of Experiments, CAPA, GMP
Job DetailsJob Location: Miramar, FL 33025Salary Range: $75,000.00 - $80,000.00 Salary/yearAbout Us: Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies.…
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Job DetailsJob Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072Position Type: Internship Assist in the preparation and submission of regulatory documents to health authorities for product registrations…
Job DetailsJob Location: Miramar, FL 33025Job Shift: DayJob Summary: The Blender Operator I is responsible for performing pharmaceutical blending and compounding operations involving active pharmaceutical ingredients (AP…
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Internship
bachelor degree, postgraduate degree
Posted 57d ago
~40 hrs/week
Responsibilities
Assist in the preparation and submission of regulatory documents such as ANDAs, MAA, and IND to health authorities. Support the maintenance of regulatory files and collaborate with cross-functional teams to ensure compliance with pharmaceutical standards.
Requirements
Candidates should be currently enrolled in a Bachelor's or Master's degree program in Pharmacy, Regulatory Affairs, or Life Sciences. Strong organizational skills, attention to detail, and proficiency in Microsoft Office are required.
Full job description
Job DetailsJob Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072Position Type: Internship Assist in the preparation and submission of regulatory documents to health authorities for product registrations, including ANDAs /MAA/ANDS/IND but not limited to these. Conduct research on regulatory requirements and guidelines applicable to generic pharmaceuticals in various markets. Support the maintenance of regulatory files and databases, ensuring accuracy and completeness of documentation. Collaborate with cross-functional teams, including Quality Assurance, R&D, and Manufacturing, to gather necessary information for regulatory submissions. Assist in the review of labeling and promotional materials to ensure compliance with regulatory standards. Participate in regulatory intelligence activities, including monitoring regulatory updates and communicating relevant information to internal stakeholders. Provide administrative support as needed, including organizing meetings, preparing meeting agendas, and documenting meeting minutes. Any other related duties as assigned by Project Leader
Master In Pharmacy
Currently enrolled in a Bachelor's or Master's degree program in Pharmacy, Regulatory Affairs, Life Sciences, or a related field. Strong attention to detail and organizational skills. Excellent written and verbal communication skills. Ability to work independently and collaboratively in a fast-paced environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Prior experience or coursework in regulatory affairs or the pharmaceutical industry is preferred.
Related keywords
Regulatory AffairsPharmacyANDAsMAAINDGeneric PharmaceuticalsQuality AssuranceR&DManufacturingHealth AuthoritiesRegulatory IntelligenceLife SciencesCompliancePharmaceutical Industry
AVEVA is a global leader in transdermal drug delivery located in the United States. The company has an extensive history of providing pharmaceutical partners with fully integrated, controlled-release transdermal products that fulfill unmet market needs or supply high-quality, affordable brand equivalents. By leveraging this experience, AVEVA offers a full range of research, development and manufacturing capabilities to produce transdermal pharmaceutical products that can improve the quality of life, usage and compliance rates for patients.
Offices: 3250 Commerce Parkway, Miramar, FL 33025, US
AVEVA is a global leader in transdermal drug delivery located in the United States. The company has an extensive history of providing pharmaceutical partners with fully integrated, controlled-release transdermal products that fulfill unmet market needs or supply high-quality, affordable brand equivalents. By leveraging this experience, AVEVA offers a full range of research, development and manufacturing capabilities to produce transdermal pharmaceutical products that can improve the quality of life, usage and compliance rates for patients.
Offices: 3250 Commerce Parkway, Miramar, FL 33025, US