Regulatory Affairs Executive

You are a highly motivated and detail-oriented Regulatory Affairs Executive, responsible for ensuring compliance with regulatory requirements and supporting the approval and lifecycle management of products in the biotechnology sector. Your key responsibilities include preparing, reviewing, and submitting regulatory documents in compliance with local and international regulations, coordinating with internal teams for necessary data, monitoring and ensuring compliance with regulatory guidelines, communicating with regulatory authorities, maintaining accurate records, staying updated on regulatory policies, and providing support in audits and inspections. To qualify for this role, you should hold a Bachelor's or master's degree in biotechnology or a related field, have 0-2 years of experience in regulatory affairs, possess basic knowledge of regulatory guidelines (e.g., FDA, EMA, CDSCO), and demonstrate strong analytical and problem-solving skills. Exposure to regulatory processes in biotechnology or pharmaceutical industry, understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), effective communication and documentation skills are preferred qualifications. Your skills should include excellent organizational and time management abilities, attention to detail, proficiency in MS Office applications, and the capacity to work independently and collaboratively in a team environment. As a self-motivated individual, you should proactively learn new regulatory requirements, exhibit strong interpersonal skills, and be flexible and adaptable to changing priorities and deadlines. The company, Technoculture Research, based in Bodhgaya, Bihar, India, focuses on developing modern technology relevant to various fields such as construction, machinery, food, drugs, and agriculture. The organization's recent project involves developing efficient water harvesting and artificial water recharge methods, with a key objective of accurately predicting hydrological conditions to aid in decision-making processes. The company conducts research and development on newly developed technologies, mainly focusing on inventing commercial and industrial products in the biotech sector, utilizing a high-tech biotech lab for research and development on biomedical, bio-mechanical, and bioelectronics products. Technoculture Research emphasizes product development, design, and innovative ideas for cost-effective solutions for the next generation.,