Senior Associate - Regulatory Operations

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 ensure 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 labelling 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 documentations, local archival system / processes, update to the databases / share-point sites as appropriate.
• Responsible to ensure compliance with all applicable regulations, QMS and corporate requirements.
• Collaborate with local stakeholders like commercial and other support functions and region/ 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, team player and good communication skills

  Others

  • Have in-depth knowledge of all relevant local regulations /requirements pertaining to product registration requirements, particularly for medical devices

  • Working knowledge in local regulations regarding other Licensing related to drug/ devices (e.g.. Test license, wholesale license, Clinical trials, NPPA filing, etc.)

  Ideal Background

  Components

  Minimum Desirable Education

  Graduate in any life science subjects/ Pharmacy graduate /Biomedical Engineering

  Masters 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 and further an experience in the area of Ophthalmology products, preferred.

  Languages:

  Proficient in English

  Specific Professional Competencies: Indicate any other soft/technical/professional knowledge and skills requirements

• Well versed with use of computers and the current software/applications generally used in industry.
• Good communication/interpersonal skills
• Should have an ability to plan/organize and prioritize activities.
• Good in time management.

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