Senior Specialist (Regulatory Affairs)

Location: Ahmedabad, Gujarat, India; onsite, full time

Company

hirify.global develops healthcare products and solutions focused on improving healthcare delivery and sustaining lives.

What you will do

• Develop and execute regulatory project plans under direction.
• Implement global regulatory strategies and support product licensing activities.
• Compile and submit regulatory documents and respond to regulatory authority questions within required timelines.
• Maintain regulatory files and update existing marketing authorizations.
• Prepare, review, and approve product labeling and standard operating procedures.
• Represent or lead Regulatory Affairs in small project teams and provide regulatory advice.

Requirements

• Bachelor’s degree or country equivalent in a scientific discipline.
• Minimum of 2 years of regulatory experience and 8–10 years of total experience in a pharmaceutical, medical device, CRO, or similar organization.
• Knowledge of regulations and scientific principles.
• Project management skills, including managing multiple projects and deadlines.
• Strong multitasking, prioritization, interpersonal, communication, and negotiation skills.
• Technical systems skills with word processing, spreadsheets, databases, and online research tools.

Culture & Benefits

• Work is connected to hirify.global’s mission to save and sustain lives.
• Culture emphasizes courage, trust, collaboration, ownership, and accountability.
• Reasonable accommodations are available for candidates with disabilities during the application and interview process.
• hirify.global is an equal opportunity employer.