Senior Associate - Regulatory Operations
Location: Bangalore, India
Time Type: Full-time
Posted: 16 Days Ago
Time Left to Apply: 6 days (Application deadline: February 21, 2025)
Job Requisition ID: R-2025-37686
Job Purpose:
The Senior Associate will manage pharmaceutical and medical device product application submissions and approvals from the Central Drugs Standards Control Organization (CDSCO), ensuring full regulatory compliance.
Major Accountabilities:
Document Management:
Procure and create all required documents according to submission plans and timelines.
Compile, review, and QC health authority submission dossiers for timely submission (e.g., via SUGAM).
Product Registration:
Facilitate product testing at government facilities, handle label development and ensure compliance with India’s regulatory labelling requirements.
Manage the maintenance of product licenses, including renewals, re-registrations, and import licenses, as well as submission of product variations.
Regulatory Information Management:
Oversee Veeva Vault RIM activities, ensuring accurate document management and record-keeping for regulatory submissions.
Collaboration:
Work with local stakeholders and global/regional teams to ensure smooth regulatory operations.
Safety Reporting:
Ensure adherence to safety reporting procedures as per relevant SOPs.
Key Performance Indicators:
Strategy/Market Focus:
Strategic planning and maintenance of regulatory licenses.
Operational Excellence:
Timely and quality completion of tasks.
People & Management:
Proactive team player with strong communication skills.
Regulatory Knowledge:
In-depth knowledge of local regulations, particularly for medical devices and drug licensing.
Ideal Background:
Education:
Graduate in life sciences, pharmacy, or biomedical engineering (Master's preferred).
Experience:
3-8 years of experience in medical device & drug regulatory affairs, specifically in Indian regulatory affairs. Experience with ophthalmology products is preferred.
Language Skills:
Proficient in English.
Professional Competencies:
Strong computer and software application skills.
Excellent communication and interpersonal skills.
Good time management, planning, and organizational skills.
Why Alcon?
Alcon is dedicated to improving patients' eye care worldwide, offering innovative devices and consumer products. With a commitment to diversity, equity, and inclusion, Alcon ensures a collaborative work environment where employees can thrive and contribute to a life-changing mission
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