Are you a highly motivated and experienced Regulatory Affairs professional looking for a new challenge? Do you have a strong understanding of regulatory guidelines and requirements for the Latin American and EU markets? If so, we have exciting news for you! Aculife Healthcare Pvt Ltd, a leading player in the healthcare industry, is hiring for a Regulatory Affairs position at its Head Office in Ahmedabad.
About the Company
Aculife Healthcare Pvt Ltd is a part of the Nirma Group, a renowned conglomerate with a strong presence in various industries. With a commitment to excellence and innovation, Aculife Healthcare Pvt Ltd is dedicated to providing high-quality products and services to its customers.
Job Description
As a Regulatory Affairs professional at Aculife Healthcare Pvt Ltd, you will be responsible for compiling and reviewing registration dossiers, reviewing technical documents, and preparing and submitting regulatory submissions. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and company policies.
Key Responsibilities
Compile and review registration dossiers as per country-specific guidelines and requirements
Review technical documents, including DMF, Product Development Report, BMR, BPR, Analytical Method Validation Report, Specification-STP, Stability Report, BE Study Report, etc.
Prepare and submit regulatory submissions and variations for post-approval changes
Communicate and follow up with overseas regulatory teams, agents, and distributors to ensure timely filing of new submissions or variations
Review various artworks and comments for ongoing commercial supply and products for the new launch
Prepare and maintain various registration databases and update them at the central depository
Requirements
6 months to 2 years of core Regulatory Affairs experience
Good technical job knowledge and understanding of regulatory guidelines and requirements
Excellent communication and interpersonal skills
Ability to work independently and as part of a team
What We Offer
Best-in-industry compensation package
Opportunity to work with a leading player in the healthcare industry
Collaborative and dynamic work environment
Professional development and growth opportunities
State-of-the-art facilities and equipment
Why Choose Aculife Healthcare Pvt Ltd?
We are a part of the Nirma Group, a renowned conglomerate with a strong presence in various industries
We are committed to excellence and innovation in the healthcare industry
We offer a collaborative and dynamic work environment that fosters growth and development
We provide opportunities for professional development and career advancement
Career Growth and Development
At Aculife Healthcare Pvt Ltd, 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
Technical documentation and review
Communication and project management
Leadership and management
Conclusion
If you’re a highly motivated and experienced Regulatory Affairs professional looking for a new challenge, we encourage you to apply for this exciting opportunity at Aculife Healthcare Pvt Ltd. With a best-in-industry compensation package, collaborative and dynamic work environment, and opportunities for professional growth and development, this is a career path you won’t want to miss.
📬 How to Apply
If you’re ready to take the next step in your Regulatory Affairs career, send your resume to:
📧 satabdeerath@aculife.co.in
Join Aculife Healthcare Pvt Ltd — where your expertise drives global healthcare excellence 🌎💊
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.
