Alcon Pharma Senior Associate Regulatory Operations

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.

APPLY ONLINE HERE

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