Great opportunity as Senior Regulatory Affairs Associate at PAREXEL

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.

Additional Information:

• 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.