DifGen Pharmaceuticals

Regulatory Affairs Intern

DifGen Pharmaceuticals  •  State of Telangāna, IN (Onsite)  •  4 hours ago
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Job Description

Job Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072
Position 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.
DifGen Pharmaceuticals

About DifGen Pharmaceuticals

We are a US based Global Pharmaceutical company with a primary focus on developing complex high barrier to entry Generics and Specialty Pharmaceutical products that would help increase accessibility to high quality medication thereby leading to the creation of next generation healthy communities. We are driven by an earnest pursuit of redefining the accepted standards in pharmaceutical product development and commercialization. We consistently aspire to challenge standard thought processes to arrive at dependable solutions that create a paradigm shift in product development, quality, clinical affairs, regulatory sciences, and commercial strategy. Our talented team with some of the brightest minds have developed a holistic understanding of the nuances associated with the development of unique, commercially viable and difficult product lines across varying therapeutic areas and a broad array of dosage forms such as Injectables, Ophthalmics, Topicals, Biologicals, Drug Devices, Soft Gels, Solid Orals & Suspensions.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Hyderabad, IN
Year Founded
Unknown
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