Regulatory Affairs Intern

DIFGEN PHARMACEUTICALS PRIVATE LIMITED; Hyderabad; On-site; INR 167,400 - 279,000; Part time

Job summary

DIFGEN PHARMACEUTICALS PRIVATE LIMITED is looking for an intern for their R&D department in Hyderabad. The role involves assisting in regulatory submissions and conducting compliance research. Candidates should be pursuing a Master's or Bachelor’s degree in Pharmacy or related fields.

The ideal intern will possess strong organizational and communication skills, with proficiency in Microsoft Office. This position offers a unique opportunity to gain experience in the pharmaceutical regulatory landscape.

Qualifications

• Master in Pharmacy is required.
• Currently pursuing a Bachelor's or Master's degree in Pharmacy, Regulatory Affairs, or Life Sciences.
• Strong attention to detail and organizational skills.

Responsibilities

• Assist in preparation and submission of regulatory documents.
• Conduct research on regulatory requirements for generic pharmaceuticals.
• Support maintenance of regulatory files and databases.
• Collaborate with cross-functional teams for regulatory submissions.
• Assist in reviewing labeling and promotional materials.
• Participate in regulatory intelligence activities.
• Provide administrative support as needed.

Skills

Attention to detail

Organizational skills

Written communication

Verbal communication

Microsoft Office Suite proficiency

Education

Master in Pharmacy

Currently enrolled in Bachelor's or Master's program in relevant field

Job description

Job Details

Location: DifGen Pharmaceuticals Pvt Ltd - R&D - Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072

Position Type: Internship

Responsibilities

• Assist in the preparation and submission of regulatory documents to health authorities for product registrations, including ANDA/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.

Qualifications

• 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.