Are you a highly motivated and experienced Regulatory Affairs professional looking for a new challenge? A leading pharma company is hiring for Regulatory Affairs professionals to join their team and work on EU, UK, and AUS-NZ regulatory submissions.
🧩About the Job
As a Regulatory Affairs professional at this leading pharma company, you will be responsible for compiling and submitting regulatory documents, including initial marketing authorisation applications and variation applications, to regulatory agencies in the EU, UK, and AUS-NZ. You will work closely with cross-functional teams to ensure that regulatory submissions are accurate, complete, and compliant with regulatory requirements.
📋Key Responsibilities
Compile modules 1, 2, and 3 of initial marketing authorisation applications for the EU, UK, and AUS-NZ
Publish regulatory documents in eCTD format and submit to the respective regulatory agencies
Compile and submit variation applications for EU, UK, and AUS-NZ
Review documents related to the compilation of dossiers and query responses
Stay up-to-date with regulatory guidelines and requirements
🎓Requirements
M. Pharm or equivalent degree in a relevant field
2-5 years of experience in Regulatory Affairs or a related field
Strong knowledge of regulatory guidelines and requirements for the EU, UK, and AUS-NZ
Excellent communication and interpersonal skills
Ability to work independently and as part of a team
Experience with eCTD submissions and regulatory document management
💼What We Offer
Opportunity to work with a leading pharma company
Collaborative and growth-oriented environment
Competitive compensation and benefits package
Professional development and growth opportunities
State-of-the-art facilities and equipment
🚀Why Choose This Opportunity?
Opportunity to work on EU, UK, and AUS-NZ regulatory submissions
Collaborative and growth-oriented environment
Professional development and growth opportunities
🎯Career Growth and Development
At this leading pharma company, we’re committed to providing our employees with opportunities for career growth and development. As a Regulatory Affairs professional, you’ll have the opportunity to work on a wide range of projects and develop your skills in areas such as:
Regulatory submissions and compliance
Document management and publishing
Cross-functional team collaboration
Leadership and management
📩 How to Apply
If this sounds like your next career move, we’d love to hear from you!
👉 Send your CV to: priyanka@extrius.co.in
❓Frequently Asked Questions
Q: What is the primary responsibility of a Regulatory Affairs professional?
A: The primary responsibility of a Regulatory Affairs professional is to ensure compliance with regulatory requirements and guidelines.
Q: What skills are required for a Regulatory Affairs professional?
A: A Regulatory Affairs professional should have strong knowledge of regulatory guidelines and requirements, excellent communication and interpersonal skills, and the ability to work independently and as part of a team.
Q: What kind of career growth and development opportunities are available?
A: We offer professional development and growth opportunities, including training and certification programs, leadership development, and opportunities to work on high-profile projects.