Walk-in for Regulatory Affairs

Walk-in for Regulatory Affairs

Experience: 1 to 4 yrs
Walkin date : 23rd Jul 18   TO  25th Jul 18
Walkin time : 11 AM
    Greetings from Tech Mahindra…
    Hiring for Regulatory Affairs

    Experience in Regulatory Experience only …
    Excellent Communication Skills in English
    Knowledge in Regulatory Affairs
    comfortable with Rotational Shifts

    Note:- Those who are attended for Regulatory Affairs with us in 3 months are not eligible

    Provides relevant source data for the Change Request
    Reviews and approves the new artwork in the Change Order(s) against the Final Brief and referring to Regulatory Approved Labelling in Country Prescribing Information /Local Datasheet
    Identifies and engages other individuals who need to be involved in the review and approval of a Change Request or Change Order, in accordance with any local procedures and requirements
    Participates in the impact assessment of a Change Request, reviewing and commenting on its viability on behalf of the market
    For changes initiated by the site: Reviews impact assessment comments and authorises the Change Request if required
    Ensures all critical checks have been carried out in accordance with the critical checklist
    Approves the Change Request, referring to Regulatory Approved Labelling in Country Prescribing Information / Local Datasheet from PRION
    Co-ordinates market activities/approvals as necessary throughout the life time of the change
    Ensure that all design and readability guidelines are adhered to across the full range of packs.
    Checks and confirms that artwork created matches authorised briefs / change orders covering multiple types of pack components, languages and formats.
    Adherence to regulatory and quality compliance requirements
    Adherence to agreed schedules for artwork production
    Ensures that data integrity and accuracy is maintained throughout the proof-reading (review of the artworks) / amendment stages
    Implements the principles of Operational Excellence and Lean Sigma to recommend and bring about continuous improvement.
    Monitors progress of artwork creation and ensures delays or issues are rectified or escalated to the appropriate level of management, and customers are kept informed of progress

    Note:-Please do carry Govt Original ID Voter ID/Pan Card/Passport/

: regulatory affairs, data integrity, quality compliance, communication skills

: B.Pharma - Pharmacy

: Trainee

Tech Mahindra Ltd

Tech Mahindra Limited is an Indian multinational provider of information technology, networking technology solutions and Business Process Outsourcing to various industry verticals and horizontals. Anand Mahindra is the Chairman of Tech Mahindra, which is headquartered at Pune and has its registered office in Mumbai.

: Vijay kumar

: Date: 23rd july to 25th July

Timing: 11:00 AM to 2:00 PM
Contact person : G vijay kumar -7013198938
Venue: Tech Mahindra -Special Economic Zone ,Tower-1 Plot no.22to 34, Hi-tech city,Madhapur,Hyderabad ,Telangaga 500081

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