CORONA Remedies Limited, headquartered in Ahmedabad, Gujarat, is a leading name in the pharmaceutical industry, recognized for its commitment to delivering quality healthcare solutions. The company specializes in developing, manufacturing, and marketing pharmaceutical products across various therapeutic segments. With a robust presence in both domestic and international markets, CORONA Remedies is dedicated to innovation, compliance, and excellence in healthcare.
Responsibilities in the Job
The Regulatory Affairs Executive will play a crucial role in ensuring regulatory compliance for the European market. Key responsibilities include:
- Dossier Management: Comprehensive handling of dossier preparation and submission for the EU market, ensuring alignment with regulatory guidelines.
- Literature Search: Conducting in-depth literature searches during the development phase of drug products.
- Cross-Department Communication: Collaborating with various departments within the plant and maintaining effective communication with clients to ensure timely dossier submission.
- Regulatory Knowledge: Understanding all regulatory pathways for EU submissions and compiling EU eCTD dossiers.
- Database Management: Managing regulatory databases, overseeing the product lifecycle, and reviewing commercial documents.
- Labeling Compliance: Staying informed about labeling requirements specific to European countries.
Required Qualifications
- Education: Candidates must hold a B.Pharm or M.Pharm degree.
Required Skills
To excel in this role, candidates must demonstrate:
- Proven experience in regulatory affairs for the European market.
- Ability to independently prepare and submit dossiers for the EU market.
- Strong communication skills to coordinate effectively with internal teams and external clients.
- Detailed knowledge of EU eCTD dossier compilation and submission processes.
- Awareness of labeling requirements for different European countries.
Job Location
This position is based at CORONA Remedies’ Head Office in Thaltej, Ahmedabad, providing an opportunity to work in a dynamic and innovative environment.
How to Apply
Candidates with relevant experience and qualifications are encouraged to apply.
- Option 1: Apply directly through the job portal.
- Option 2: Send an updated CV to yashb@coronaremedies.com with a clear subject line highlighting your application for the Regulatory Affairs Executive – Europe Market role.
