The Role
Support preparation and submission of regulatory documents for generic pharmaceuticals, research regulatory requirements, maintain regulatory files, collaborate with QA/R&D/Manufacturing, review labeling, monitor regulatory updates, provide administrative support, and assist project leader with related tasks.
Summary Generated by Built In
- 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
- 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.
Skills Required
- 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
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The Company
What We Do
DifGen Pharmaceuticals is a US-based global pharmaceutical company specializing in the development and manufacturing of complex, high-barrier-to-entry generic and specialty pharmaceutical products. The company focuses on creating dependable solutions in product development and commercialization to increase accessibility to high-quality medications, thereby leading to the creation of next-generation healthy communities.
