Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Location: Bodhgaya, Bihar

Company: Vastu Vihar Biotech Pvt Ltd

About Us:

Vastu Vihar Biotech Pvt. Ltd. , located in Bodh Gaya, Bihar, is focused on developing a drug based on Ribozyme for diseases such as Asthma, Psoriasis, and Chronic Hepatitis. Our goal is to become a leading contributor to the service of mankind by finding ways to combat deadly diseases. With successful and active results in vivo and in vitro testing, we are forging ahead in the journey towards drug development with Ribozyme as the drug molecule.

Job Description:

As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements related to Regulations and Standards, e.g., FDA, EMA, ISO. You will work closely with cross-functional teams to support product development, registration, and post-market activities. This role offers the opportunity to contribute to the success of innovative projects while ensuring regulatory compliance in a dynamic and fast-paced environment.

Key Responsibilities:

• Prepare and submit regulatory submissions, including but not limited to, product registrations, notifications, and filings.
• Review and interpret regulatory requirements and guidelines to ensure compliance throughout the product lifecycle.
• Collaborate with internal stakeholders to provide regulatory guidance and support for new product development and changes to existing products.
• Maintain regulatory documentation and databases, ensuring accuracy and completeness.
• Monitor regulatory developments and communicate relevant changes to stakeholders.
• Participate in regulatory agency interactions, including meetings, inquiries, and inspections.
• Support regulatory audits and inspections, ensuring timely and appropriate responses to regulatory authorities.

Qualifications:

• Bachelor's or Master's degree in Regulatory Affairs, Life Sciences, Pharmacy, Chemistry, or Biology.
• Prior experience in regulatory affairs is preferred but not required for entry-level candidates.
• Knowledge of regulatory requirements and guidelines.
• Strong attention to detail and excellent organizational skills.
• Effective communication and interpersonal skills, with the ability to collaborate across functions.
• Ability to manage multiple projects and priorities simultaneously.
• Proficiency in Microsoft Office Suite and regulatory software applications.