HLL Lifecare Limited (HLL), India's leading manufacturers and marketers of contraceptive, Health Care and Pharma products is a Mini Ratna Central Public Sector Enterprise under the Ministry of Health and Family Welfare. With 7 manufacturing units, 3 subsidiary companies and Diagnostic Labs / LIfecareCentres throughout the country, HLL has also forayed into developing Medical Technology Parks (MEDIPARKS).
Post: HEAD (REGULATORY CELL)-(01 post)
Tasks:
This is a senior level position. The selected candidate shall be responsible for the Regulatory Affairs function for the entire company. He / she will lead a group of regulatory professionals who will carry out the below mentioned tasks:
• Responsible for Regulatory Affairs function for developed / regulated and unregulated markets for US, Europe & Rest of the world
• Organizing the required documents formats for CTD, ACTD & Country Specific format for international & other ROW market.
• Review & Submission of the Dossiers/Application to MOH India for Registration & Re-Registration of Products and its Manufacturing sites for Pharmaceutical, Medical Devices and other Products
• Respond to queries raised by regulatory authorities.
• Organise information related to Sterility assurance for all sterile products.
• Preparation of drug master files, site master files and dossiers for EU & ROI.
• Interacting with DCGI / Local FDA / CDTL / FSSAI / Other Government Bodies for submission & obtaining of permissions and to sort out any Regulatory issues.
• Review of specifications like RM, FP and Stability for regulatory compliance.
• Coordination with various departments like R&D, QC, QA, Production, and Marketing.
• Provide support to plant during time of audits of various Regulatory Agencies/customer.
• Artwork and Labelling process / Compliance. Review and approval of the Artwork as per the current regulations & laws of D&C Act.
• Keeping updates on regulatory requirements for submission of DMFs to regulatory authorities of various regions like US, EU, and Rest of the world. Track trends, anticipate critical regulatory landscape changes, leverage opportunities and address challenges.
• Develop strong partnerships with in-country (e.g. Medical, Marketing, Supply Chain) and Therapeutic Area and Regional and Global Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, Generic Products, Medical Devices, line extensions and life-cycle optimization
• Provide support to the Institutional Business / Tender Business with required documents e.g., Performance Certificate, No Objection Certificate, No Conviction Certificate, Manufacturing / Market Standing Certificate, Free Sale Certificate etc.
• Experience in dealing with FDA, FSSAI, DCGI and MoH
Requirements:
Maximum Age: 50 Years as on 01/07/2016.
Scale of Pay:Rs.32900-58000 (DVP) / Rs.36600-62000 (AVP) / Rs.43200-66000 (VP) Annual CTC: Rs.13.4 lakhs (DVP) / Rs.14.9 lakhs (AVP) / Rs.17.6 lakhs (VP) - (approx.) at the minimum of the scale.
Qualification:
Essential: M.Pharm/ M.Sc Chemistry/ BE or BTech (Chemical Engineering)
Desirable: Ph.D Science / Pharma or ME or MTech (Chemical Engineering)
Post Qualification Experience:
Essential:
1) Minimum 15 years of relevant experience in handling RegulatoryAffairs forreputed Pharmaceutical Companies
2) Acquainted with global regulatory norms
Desirable: Leadership role in Regulatory Affairs department of major Pharmaceutical companies
Contract Type: The nature of vacancy is Permanent and the appointment shall be on permanent / fixed term contract basis. If taken on fixed term contract basis, the candidate will be offered scale of pay and other benefits as applicable to permanent employees of his/her grade and will be considered for absorption in permanent rolls on expiry of the contract period, subject to performance assessment.
End Date: 17th August, 2016
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