Regulatory Affairs Intern

Aveva Drug Delivery Systems; Hyderabad; On-site; INR 223,200 - 334,800; Full time

Job summary

Aveva Drug Delivery Systems is looking for an intern to assist with regulatory submissions in Hyderabad, Telangana. Responsibilities include preparing regulatory documents and collaborating with various teams.

The ideal candidate should be enrolled in a relevant degree program and possess strong communication and organizational skills. Prior experience in regulatory affairs is preferred. This internship provides valuable exposure to the pharmaceutical industry.

Qualifications

• 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.

Responsibilities

• Assist in the preparation and submission of regulatory documents to health authorities.
• Conduct research on regulatory requirements and guidelines for generic pharmaceuticals.
• Collaborate with cross-functional teams to gather information for regulatory submissions.

Skills

Attention to detail

Organizational skills

Communication skills

Microsoft Office Suite

Education

Bachelor's or Master's degree in Pharmacy or related field

Job description

Job Location: 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 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.

Qualifications

• 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.