Regulatory Affairs Associate
HR Footprints Management Services · Hyderabad · onsite · Posted 69d ago
About a minute. You'll make an account on the way through.
About this role
Roles and Responsibilities :
- Manage drug regulatory affairs, including dossier preparation, submission, and approvals from US FDA (US Food and Drug Administration).
- Coordinate with cross-functional teams to ensure timely completion of regulatory requirements throughout the product lifecycle.
- Prepare and review variation applications, renewals, and other documentation related to drug regulations.
- Provide guidance on regulatory compliance matters to internal stakeholders.
Job Requirements :
- 5-7 years of experience in pharmaceutical industry with expertise in drug regulatory affairs.
- Strong understanding of USFDA guidelines and regulations governing drug development process.
- Proficiency in preparing dossiers for regulatory submissions, including eCTD format.
Sourced from naukri
Skills
About HR Footprints Management Services
HR Footprints Management Services
Recruitment
51
employees
2006
20 years old
Hyderabad
India
₹5L – ₹7L PA
This role
About
HR Footprints is an HR Management Services Company providing services in the area of HR processes outsourcing. Founded in the year 2006, we have successfully completed 600+ assignments and have 25,000+ learners across HR Consulting, Learning and Organisational Development, Leadership Coaching and Talent Sourcing.
We at HR Footprints believe in taking the time to work with you and your staff very closely to custom-tailor every component of your program to provide more personal, measurable goals. We work with our clients as their extended arms to provide HR Management services in HR Consulting, Learning and Development, Leadership Coaching and Talent Sourcing.
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