The Role
Support preparation and submission of regulatory documents, track global regulatory updates, maintain regulatory files and PLCM, collaborate with QA/R&D/Manufacturing, review labeling/promotional materials for compliance, conduct regulatory intelligence, and provide administrative support.
Summary Generated by Built In
- Assist in the preparation and submission of regulatory documents to health authorities for product registrations, including ANDAs/MAA/DCP/ANDS etc but not limited to these.
- Periodic tracking of evolving Global Regulatory updates and updating to team and implimentation of the new expectations of Global competent Regulatory Agencies and review of all relevant data inclusive of the Type II DMF/ASMF etc.
- Support the maintenance of regulatory files and databases, PLCM, 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 Master of Pharmacy 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
- Currently enrolled in a Master of Pharmacy 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.
