Are you a Regulatory Affairs professional with expertise in UK/European markets? We are hiring 3 Executives for Regulatory Affairs to join our team in Bangalore. If you have a strong background in pharmaceutical regulatory submissions, especially in UK/EU dossier preparation, this is the perfect opportunity for you!
About the Role
We are seeking talented individuals with 2-4 years of experience in Regulatory Affairs, particularly in UK/European submissions. As a Regulatory Affairs Executive, you will play a key role in dossier preparation, gap assessment, and regulatory compliance for the UK and European markets.
Key Responsibilities
- Dossier Preparation: Compile and review UK/EU dossiers with a focus on CMC sections.
- Regulatory Compliance: Ensure compliance with MHRA/CSP guidelines and prepare eCTD dossiers for submission.
- Document Review: Conduct gap assessments and review documents as per UK/EU regulatory guidelines.
- Client Interaction: Respond to client queries and provide regulatory expertise.
- Stay Updated: Monitor and implement new regulatory requirements for the UK and European markets.
Education and Experience
- Educational Qualification: PG/Bachelor’s degree in Pharma/Science (preferably in Life Sciences).
- Experience: 2-4 years of experience in regulatory submissions, specifically for UK/European markets.
- Skills: Strong understanding of CMC documentation, eCTD authoring, and regulatory strategy.
Why Join Us?
- Work with a leading pharmaceutical company in Bangalore.
- Gain exposure to UK/European regulatory affairs and enhance your career.
- Be part of a team that values innovation, compliance, and professional growth.
How to Apply
If you are passionate about Regulatory Affairs and meet the above requirements, we would love to hear from you! Please share your CV to info@ipharmed.com.
