HLL Lifecare Restricted (HLL), India’s main producers and entrepreneurs of contraceptive, Well being Care and Pharma merchandise is a Mini Ratna Central Public Sector Undertaking underneath the Ministry of Well being and Circle of relatives Welfare. With 7 production devices, three subsidiary firms and Diagnostic Labs / LIfecareCentres during the rustic, HLL has additionally forayed into creating Clinical Generation Parks (MEDIPARKS).
Submit: HEAD (REGULATORY CELL)-(01 publish)
This can be a senior degree place. The chosen candidate will probably be chargeable for the Regulatory Affairs serve as for all of the corporate. He / she is going to lead a gaggle of regulatory pros who will perform the under discussed duties:
• Chargeable for Regulatory Affairs serve as for evolved / regulated and unregulated markets for US, Europe & Remainder of the arena
• Organizing the specified paperwork codecs for CTD, ACTD & Nation Particular layout for global & different ROW marketplace.
• Assessment & Submission of the Dossiers/Software to MOH India for Registration & Re-Registration of Merchandise and its Production websites for Pharmaceutical, Clinical Units and different Merchandise
• Reply to queries raised by way of regulatory government.
• Organise knowledge associated with Sterility assurance for all sterile merchandise
• Preparation of drug grasp information, website online grasp information and dossiers for EU & ROI.
• Interacting with DCGI / Native FDA / CDTL / FSSAI / Different Executive Our bodies for submission & acquiring of permissions and to type out any Regulatory problems.
• Evaluation of specs like RM, FP and Balance for regulatory compliance.
• Coordination with more than a few departments like R&D, QC, QA, Manufacturing, and Advertising.
• Supply improve to plant throughout time of audits of more than a few Regulatory Businesses/buyer.
• Paintings and Labelling procedure / Compliance. Assessment and approval of the Paintings as according to the present laws & regulations of D&C Act.
• Preserving updates on regulatory necessities for submission of DMFs to regulatory government of more than a few areas like US, EU, and Remainder of the arena. Monitor tendencies, await crucial regulatory panorama adjustments, leverage alternatives and cope with demanding situations.
• Expand robust partnerships with in-country (e.g. Clinical, Advertising, Provide Chain) and Healing Space and Regional and International Groups to facilitate the improvement and implementation of registration methods to expedite the registration of latest merchandise, Generic Merchandise, Clinical Units, line extensions and life-cycle optimization
• Supply enhance to the Institutional Industry / Gentle Industry with required paperwork e.g., Efficiency Certificates, No Objection Certificates, No Conviction Certificates, Production / Marketplace Status Certificates, Loose Sale Certificates and so on.
• Revel in in coping with FDA, FSSAI, DCGI and MoH
Most Age: 50Years as on 01/05/2016.
Scale of Pay:Rs.32900-58000 (DVP) / Rs.36600-62000 (AVP) / Rs.43200-66000 (VP) Annual CTC: Rs.13.four lakhs (DVP) / Rs.14.nine lakhs (AVP) / Rs.17.6 lakhs (VP) – (approx.) on the minimal of the size.
Very important: M.Pharm/ M.Sc Chemistry/ BE or BTech (Chemical Engineering)
Fascinating: Ph.D Science / Pharma or ME or MTech (Chemical Engineering)
Submit Qualification Revel in:
1) Minimal 15 years of related revel in in dealing with RegulatoryAffairs forreputed Pharmaceutical Firms
2) Conversant in international regulatory norms
Fascinating: Management position in Regulatory Affairs division of primary Pharmaceutical firms
Contract Sort: The character of emptiness is Everlasting and the appointment can be on everlasting / fastened time period contract foundation. If taken on fastened time period contract foundation, the candidate might be presented scale of pay and different advantages as appropriate to everlasting workers of his/her grade and shall be thought to be for absorption in everlasting rolls on expiry of the contract duration, topic to efficiency review.
Finish Date: 22th June, 2016