PAREXEL is a leading global biopharmaceutical service provider that supports the bio-tech and pharmaceutical industries in the development of new drugs and treatments on a global basis. They offer various services including knowledge-based contract research, medical communications, and consulting services.
PAREXEL collaborates with pharmaceutical, biotechnology, and medical device companies worldwide to help them navigate the complex process of drug development and bring innovative treatments to patients. Their services span across a broad range of therapeutic areas, addressing the diverse needs of their clients. Through their contract research services, PAREXEL conducts clinical trials and provides expertise in areas such as study design, data management, statistical analysis, and regulatory affairs.
Job Title: Senior Regulatory Affairs Associate
Job Description: The Senior Regulatory Affairs Associate will be responsible for supporting labelling activities related to submissions in the European Union (EU) and the United States (US). This position requires a willingness to work in EU shifts (12:00 PM – 9:00 PM). The key responsibilities include:
- Managing CCDS (Company Core Data Sheet) and safety submissions.
- Overseeing labelling management and artwork updates.
- Handling and responding to requests from Health Authorities.
- Demonstrating excellent individual project management and communication skills.
- Experience working with the Veeva tool.
Candidate Profile: The ideal candidate should meet the following criteria:
- Possess a Bachelor’s or Master’s degree in Pharmacy or a related Life Sciences field.
- Have a minimum of 5-8 years of relevant experience in regulatory affairs within the pharmaceutical or healthcare industry.
- Qualification: Bachelor’s/Master’s degree in Pharmacy, Life Sciences.
- Location: Bengaluru.
- Industry Type: Pharma / Healthcare / Clinical research.
- End Date: 30th July 2023.
This position offers an opportunity to contribute to the regulatory affairs activities of a leading global biopharmaceutical service provider. The successful candidate will be part of a dynamic team working on regulatory submissions, labelling management, and interactions with Health Authorities.
To apply for this job please visit jobs.parexel.com.