Legal Head Designation: Head - Legal & Secretarial Job Location: Corporate Office, Ahmedabad Qualification: LLB, LLM, CS Responsibility: 1. Legal: a) Keeping track of changing legislation and its impact on organisation b) Overseeing legal issues arising out of the Drug & Cosmetic Act, Narcotic Drugs and Psychotropic Substances Act and other drug regulations. c) Handling and replying of Legal notices received from Drug Regulators or any other Authority 2. Agreements: a) Drafting and Vetting of various Agreements like International partnership agreements, Confidentiality agreements, Third Party, C&F, Stockists b) Overseeing timely renewals of Agreements 3. Litigation & Legal Notices: a) Appointing Advocates on record (AOR) b) Identifying appropriate Solicitors c) Deciding Senior Counsels d) Following up and holding conferences / meetings with such AORs, Solicitors and Senior Counsels to ensure efficient conducting of case proceedings. e) Attending matters in the Court to ensure effective hearing. f) Overseeing finding of relevant case laws. To decide applicability of such relevant case laws in required matters viz. Replies, Representations, Legal notes etc. g) Keep a track in the proceedings / processes involved and necessarily follow up required in the legal notices issued / replied and in the ongoing / new litigation. 4. Secretarial: a) Overseeing Statutory Compliances of various Acts b) Overseeing monthly, quarterly, half yearly and annual compliances under various Drug /Productions laws (D&C Act, NDPS Act, FSSA etc.), Environment, Health & Safety laws (Environment act, Pollution laws), HR & labour laws (Factory laws, PF, Shops & Establishment Act etc.), Companies Act 2013 and other corporate laws. 5. Regulatory (Shifted from Corp Affairs as per advice of CMD sir): a) Drive Policy Advocacy on CT waiver projects & technical matters. b) Review and finalize all regulatory correspondence pertain to clinical trial I, II, III, IV, CMC requirements, Post approval changes, Market authorization and various manufacturing & test license. c) Scientific evaluation of applications, monitoring queries and forecasting approvals pertains to: (A) New Drugs (B) Investigational New Drugs (C) Fixed Dose combination (D) Biological d) Pre SEC/IND and Pre-filling feedback on projects. e) Summarize Minutes of meetings of DTAB & DCC and communicate to concern internal department. f) Follow up for regulatory compliance as per GSR/Public notice/notifications. g) Attend health authorities meeting, preparation of these meetings and meeting related materials. h) Provide strategic input of regulatory pathway for projects. i) Maintain high level of credibility and fruitful relationship with key members of regulatory agencies. j) Follow up and communication with CDSCO(Central Drugs Authority), FDA, ICMR, FSSAI and other regulatory authority wherever needed

Ahmedabad

Legal Head - Pharma 

Legal Head - Pharma  ,Job Description for Legal Head - Pharma  in Propella Consulting Group in  Ahmedabad for (15-20) years of experience. Apply Now!

Job Description for Legal Head - Pharma  in Propella Consulting Group in  Ahmedabad for (15-20) years of experience. Apply Now!