Alcon Pharma Senior Associate Regulatory Operations, Apply Online
Senior Associate – Regulatory Operations
Location: Bangalore, India
Job Type: Full-time
Posted On: Posted Yesterday
Time Left to Apply: End Date: February 21, 2025 (21 days left to apply)
Job Requisition ID: R-2025-37686
Job Purpose
Ensure pharmaceutical and medical device product application submissions and approvals from Central Drugs Standards Control Organization (CDSCO), India while fulfilling all regulatory compliance requirements.
Major Accountabilities
- Collection/procurement/creation of all required documents well in advance as per submission plan & timelines.
- Compilation/review/QC of all health authority submission dossiers and ensure timely submission to relevant authorities (through electronic portal (e.g. SUGAM) as applicable).
- Handling query responses if any and ensuring approvals as per project plan.
- Handling all product registration-related activities, including end-to-end facilitation of product testing at government testing facilities.
- Handling label development through Alcon platforms (e.g. CLEAR) and redress labels, as per India labeling regulatory requirements.
- Maintenance of product licenses, i.e., renewal/re-registration and import licenses/timely retention fee payment for applicable licenses (India), submission of ‘Product variations’ as per local regulations & global Alcon requirements.
- Handling end-to-end Veeva Vault RIM activities for the assigned projects and all necessary record management of regulatory submission documentation, local archival system/processes, update to the databases/share-point sites as appropriate.
- Responsible for ensuring compliance with all applicable regulations, QMS, and corporate requirements.
- Collaborate with local stakeholders like commercial and other support functions and regional/global regulatory teams.
- Safety reporting as per relevant Alcon SOPs.
Key Performance Indicators
Strategy/Market Focus
- Strategic thinker in planning and maintaining regulatory licenses.
Operational Excellence
- Quality mindset with timely completion of assigned tasks.
People, Capabilities & Management
- Be proactive, a team player, and have good communication skills.
Others
- Have in-depth knowledge of all relevant local regulations/requirements pertaining to product registration, particularly for medical devices.
- Working knowledge in local regulations regarding other licensing related to drugs/devices (e.g., Test license, wholesale license, Clinical trials, NPPA filing, etc.).
Ideal Background
Education:
- Minimum: Graduate in any life science subjects/Pharmacy graduate/Biomedical Engineering.
- Desirable: Master’s in any life sciences, pharmacy, or biomedical engineering.
Experience Requirement:
- 3-8 years of experience in medical device & drug regulatory affairs.
- Specific experience in Indian Medical Device regulatory affairs, with experience in Ophthalmology products preferred.
Languages:
- Proficient in English.
Specific Professional Competencies:
- Well-versed with the use of computers and the current software/applications generally used in the industry.
- Good communication/interpersonal skills.
- Ability to plan, organize, and prioritize activities.
- Good time management skills.
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