Are you a fresh graduate with a passion for biotechnology and regulatory affairs? Technoculture Research, based in Bodhgaya, Bihar, is actively hiring a Regulatory Affairs Executive to join their dynamic team. This exciting role offers you the opportunity to work in a high-tech biotech lab, involved in cutting-edge research and development for various industries, including construction, agriculture, and biomedical products. With a competitive salary and the chance to grow in a rapidly advancing field, this is the perfect opportunity for a fresher to kick-start their career.
About Technoculture Research
Technoculture Research is a forward-thinking company that specializes in developing innovative technologies that cater to various industries such as construction, machinery, food, drugs, and agriculture. One of their key projects involves creating efficient water harvesting and artificial recharge methods, aimed at predicting hydrological conditions and improving decision-making processes. They are also involved in the development of biomedical, bio-mechanical, and bioelectronics products, as well as designing cost-effective solutions for the next generation.
Since its inception, Technoculture Research has been at the forefront of technological research and development, offering a collaborative environment where innovation thrives.
Responsibilities of the Regulatory Affairs Executive
As a Regulatory Affairs Executive, you will play a crucial role in ensuring that the company’s products comply with local and international regulatory requirements. Your key responsibilities include:
- Document Preparation: You will prepare, review, and submit regulatory documents and applications in line with regulatory requirements.
- Coordination: Work with internal teams to collect necessary data and documentation for regulatory submissions.
- Compliance Monitoring: Ensure all activities comply with applicable regulatory guidelines, standards, and legislation.
- Regulatory Communication: Communicate with regulatory authorities to address queries and facilitate approvals.
- Record Maintenance: Maintain accurate records of regulatory submissions, approvals, and compliance activities.
- Regulatory Updates: Stay updated on changes in regulatory policies, especially those relevant to biotechnology.
- Support During Audits: Assist with audits and inspections conducted by regulatory bodies.
Qualifications Required
To be eligible for this role, you should meet the following criteria:
- A Bachelor’s or Master’s degree in Biotechnology or a related field.
- 0-2 years of experience in regulatory affairs or a similar role.
- Basic understanding of regulatory guidelines and standards (such as FDA, EMA, CDSCO).
- Strong analytical skills and problem-solving abilities.
Preferred Qualifications
While not mandatory, the following qualifications will give you an edge:
- Exposure to regulatory processes in the biotechnology or pharmaceutical industry.
- Understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Strong documentation and communication skills.
Key Skills for Success
To excel in this position, the following skills are crucial:
Strong interpersonal skills and the ability to build relationships across teams.
Excellent organizational and time management skills.
Attention to detail and a commitment to accuracy.
Proficiency in MS Office applications, especially MS Excel.
Ability to work independently and collaboratively within a team environment.