Latest job for MSc Chemistry graduates – Regulatory Affairs Expert Role – Check out the details below – Apply Now
Role : Regulatory Affairs Expert
Location : New Delhi, IN Pune, IN
Company : Oro Agri India
Key Responsibilities:
• Devise and implement plans to comply with product registration and regulatory standards.
• Compile and submit registration documents to regulatory agencies in a timely and effective manner.
• Collaborate with regulatory agencies to resolve any inquiries or concerns pertaining to product registration.
• Keep abreast of modifications to regulatory prerequisites and ensure adherence to relevant regulations for all products.
• Oversee the process of collecting data for product registration, including study planning, Job Description protocol creation, data analysis, and report composition.
• Cooperate with both internal and external stakeholders to gather the requisite data and documentation for registration documents.
• Ensure that all data produced complies with regulatory requirements and is of exceptional quality.
• Work closely with other departments, such as R&D, quality assurance, and marketing, to ensure a successful product launch.
• Maintain accurate records of all registration-related activities.
Education and Knowledge:
Academic Background
1. Master’s or degree in a relevant scientific field such as chemistry, biology, or
agronomy.Experience & Skills
1. Minimum of 6 to 8 years of experience
2. Experience in the registration of bio nutrition and biocontrol products and pesticides in India
3. Experience in data generation and compilation of dossiers for product registration in India.
4. Knowledge of the Central Insecticides Board and Registration Committee (CIBRC) and their regulations for the registration of agricultural chemicals
5. Excellent communication and interpersonal skills, with the ability to work effectively with internal and external stakeholders
6. Strong project management skills, with the ability to manage multiple projects simultaneously
7. Attention to detail and ability to work independently
Discover the Latest job for MSc Chemistry at Rasayanika
Here are some interview questions and sample answers for the role of a Regulatory Affairs Expert at Oro Agri India:
1. Can you describe your experience in devising and implementing plans to comply with product registration and regulatory standards?
Sample Answer: In my previous role as a Regulatory Affairs Expert at [Previous Company], I was responsible for developing and executing comprehensive regulatory compliance strategies for our agricultural products. This included conducting thorough assessments of local and national regulatory requirements, collaborating with cross-functional teams to ensure product compliance, and creating effective plans to meet registration deadlines. I also maintained a strong record of successful product registrations, which demonstrates my ability to devise and implement compliance plans effectively.
2. How do you stay updated on modifications to regulatory prerequisites and ensure adherence to relevant regulations for all products?
Sample Answer: Staying current with regulatory changes is crucial in this field. I regularly monitor updates from regulatory agencies such as the Central Insecticides Board and Registration Committee (CIBRC) in India. I am also an active member of professional associations related to regulatory affairs, attend relevant seminars and conferences, and subscribe to industry publications. This proactive approach allows me to anticipate regulatory changes and adjust our strategies and plans accordingly to ensure strict compliance.
3. Can you provide an example of a challenging situation where you had to collaborate with regulatory agencies to resolve inquiries or concerns related to product registration?
Sample Answer: In a previous role, we faced a situation where a regulatory agency raised concerns about the safety data we submitted for one of our pesticide products. I immediately initiated communication with the agency, offered to provide additional data and analysis, and arranged a meeting to address their concerns comprehensively. Through transparent and open communication, we were able to clarify their doubts, provide the necessary information, and ultimately secure the product’s registration. This experience highlights my ability to collaborate effectively with regulatory agencies to resolve issues and maintain compliance.
4. How do you ensure the quality and regulatory compliance of the data collected for product registration?
Sample Answer: Ensuring data quality and regulatory compliance is a priority in my work. I implement rigorous quality control measures throughout the data collection process, including study planning, protocol creation, and data analysis. I ensure that all data collected follows Good Laboratory Practices (GLP) and relevant regulatory guidelines. Additionally, I conduct regular internal audits and review processes to guarantee that the data complies with regulatory requirements and maintains exceptional quality.
5. Describe your experience in working with cross-functional teams, including R&D, quality assurance, and marketing, to ensure a successful product launch.
Sample Answer: Collaborating with cross-functional teams is essential for a successful product launch. In my previous role, I closely worked with R&D to provide regulatory guidance during product development, collaborated with quality assurance to ensure product quality and safety, and partnered with marketing to communicate regulatory compliance effectively to customers. By facilitating effective communication and alignment between these departments, we were able to bring products to market efficiently while ensuring full compliance with regulatory standards.
Explore the Latest job for MSc Chemistry at Rasayanika
ALL THE BEST!
