UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA. UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries. We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement. As part of our further expansion and growth plans, we are looking to hire Assistant Manager / Manager Regulatory Affairs Complex Products an aggressive / dynamic Regulatory Affairs Professional. This position is based at our R&D center at Turbhe Navi Mumbai and will report to the Head Regulatory Affairs. The remuneration package will be commensurate with the incumbents professional experience and will be in line with market standards. Essential skills and experience: The incumbent must have min. 10+ years’ experience in the pharmaceutical industry with a minimum of 10-12 years’ experience handling Regulatory compliance across the US, European and UK market specializing in 505(b)(2) NDAs, Hybrid Applications, IND submissions, and complex drug approvals. . Specifically, the incumbent will be responsible for: Preparation and Submission of Pre-IND meetings Request and Packages and IND/NDA submissions ensuring compliance with FDA & EMA. Define nonclinical and clinical study requirements for 505(b)(2), including bridging studies. CTD dossier preparation (Modules 1-5) and CMC document review. Address comparability studies, bioequivalence challenges, and formulation complexities. Manage post-approval variations, renewals, and compliance updates. Engage in EMA scientific advice meetings and FDA Pre-IND consultations. Required Skill: Expertise in 505(b)(2), IND/NDA/Hybrid Applications, and CMC compliance for US/EU. Strong knowledge of EMA/FDA guidelines, clinical trial regulations, and GMP standards. Experience with eCTD submissions, CMC documentation, and regulatory risk mitigation. Familiarity with eCTD software’s for regulatory submissions. Experience on the labeling updates required for complex product for 505b2. Experience on Pediatric Study Plan Submission and Approval, Post approval Study Requirements Experience on PDUFA Fees Requirements and Waiver Applications Preferred Education requirements: Bachelor’s/master’s in pharmacy, or Regulatory Affairs. Candidate having Certifications in Regulatory Compliance or Drug Development Clinical Studies preferred.

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA. UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries. We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement. As part of our further expansion and growth plans, we are looking to hire Executive / Sr Executive/ Assistant Manager Regulatory Affairs an aggressive / dynamic Regulatory Affairs Professional. This position is based at our R&D center at Turbhe Navi Mumbai and will report to the AGM - Regulatory Affairs The remuneration package will be commensurate with the incumbent’s professional experience and will be in line with market standards. Essential skills and experience: The incumbent must have min. 10+ years’ experience in the pharmaceutical industry with a minimum of 06-10 years’ experience handling Regulatory compliance across the European and UK market. . Specifically, the incumbent will be responsible for: Responsible for filings of MA applications for EU and UK market Responsible for preparation of checklist for documents required for initial submission for EU and UK market Responsible for review of new projects documents for EU and UK market Responsible for review of documents like specification, MFC, MPR, Vendor documents and submission related documents Responsible for handling of comments received from Regulatory Authority of EU and UK Co-ordinate with various departments like Formulation and manufacturing plant for filing documentation/ customer query Provide dossier for online audit to concerned customers. Submitting response to due diligence and the proceeding activities. Coordination with API supplier for regulatory activities. Co-ordinate with Packaging development department for Product information and artwork preparation/ updation for new/ approved products Co-ordinate with various consultant for activity related initial submission and query response. Responsible for change control review, approval and maintenance in particular folder. Updation of product approval status, monthly status, variation tracker, change control tracker etc. Other responsibilities: Maintenance of Documents in particular Folder Maintain and follow-up of Invoice and entry of Invoice in Excel Sheet Preparation of list for pending payment and future invoices. Co-ordinate with account department to make sure that payment completed on time and avoid Penalties. Review of Agreement eCTD uploading and submission EU lifecycle management Preferred Education requirements: Bachelor’s/master’s in pharmacy, or Regulatory Affairs. Candidate having Certifications in Regulatory Compliance or Drug Development Clinical Studies preferred.

Walk-In Interview Date : 22nd June 2025 (Sunday) Timing : 9.00 AM to 1.30 PM Venue : Umedica Laboratories Pvt, Ltd. Plot No 221,221/1 II Phase GIDC Nr Morarji Circle, Vapi 396195. 1. Tablet Manufacturing Department: Ability to handle process like Dispensing, Granulation, Compression, Coating, SOPs preparation, well versed with ALCOA & GDP principles. QMS Manufacturing investigation (OOS/OOT/Deviation/CAPA),Training.) Position: Officer to Sr. Executive Qualification: M.Sc. / B.Pharm / M.Pharm No. of Vacant Position: 20 Experience: 2 to 8 years To Operate Granulation lines (RMG/FBD/FBP/Roll Compactor), Automatic Compression Machine (PLC/SCADA based Cadmach & Fluid Pack), Coating (Kevin & Gansons) Position :Technical Associates (Operator) Qualification: ITI / Diploma /BSc Experience: 1 to 5 years No. of Vacant Position: 15 2. Tablet Packing Department: Should have sound knowledge in SOPs, BPR, Line Clearance, Daily formats &records, Manpower Handling GDP, GMP. Position: Officer to Executive Qualification: B.Pharm / M.Pharm / MSC No. of Vacant Position: 15 Experience: 2 to 8 years To Operate Blister Pack Machine ELMACH 3015 PDA machine/ IC 150C / WKH100 Cartonator machine/ Track and Trace machine with Temper Evident., CVC Primary & Secondary) Position: Technical Associates (Operator) Qualification: ITI / Diploma /BSC Experience: 2 to 5 years No. of Vacant Position: 15 3. Injectable Department: (Should have sound knowledge require in SVP, Aseptic Vial & Ampule filling, Washing, Autoclave & Sterilization. .) Position: Officer to Sr. Officer Qualification: B.Pharm / M.Pharm / BSC/ MSC Experience: 1 to 7 years No. of Vacant Position: 10 4 . Quality Control Department: Candidates having educational qualification of BSc/MSc with specialization in Chemistry. Organic chemistry/Analytical chemcistry with experience of 2 to 7 years in Quality control departments. Working exposure in HPLC, GC, UV Vis spectrophotometer, FTIR, Melting point, Dissolution Apparatus etc with regulatory exposure of USFDA/MHRA/EU/Brazil ANVISA/TGA/WHO audit. .) Position: Officer to Executive Qualification: B.Pharm / M.Pharm / BSC / MSC . Experience: 1 to 7 years No. of Vacant Position: 15 5. QA Department: (Should have sound knowledge in, Audit Trial, QMS , Training, SOP Preparation , IQPA Activities & Process Validation Position: Officer to Sr. Officer Qualification: B.Sc / M.Sc. / B.Pharm / M.Pharm Experience: 1 to 6 years No. of Vacant Position: 05 6. TTD Department: Preparation of plan regarding transfer of process / product from development, scale-up, manufacturing of exhibit / submission, launch to post approval phase which shall encompass the quality aspects (including risk assessment principles) and necessary regulatory requirement aspects. Co-ordination between R & D / client (product transferring unit) and all applicable stake holder departments in the plant (receiving unit) so as to ensure the smooth and effective transfer of product. Position: Officer to Sr. Officer Qualification: B.Pharma / M.Pharma Experience: 1 to 6 years. 7.Warehouse Department: (Should have sound knowledge in SAP, Handling of Qms Activity , handling of Purchase order, Purchase Requisition, GRN, RM, PM activities. Position: Officer to Sr. Officer Qualification: / B.com / M.com / B.Sc No. of Vacant Position: 02 8.Packaging Development Department: (Should have sound knowledge in Art Work & Product Design) Position: Officer to Sr. Officer Qualification: Diploma /B.E - Printing & Packaging Technology No. of Vacant Position: 02 Kindly carry below listed documents during interview. 1. Latest Passport size photo 2. Latest updated resume 3. Xerox copy of Qualification Certificates 4. Salary Slip / Appointment letter copy of current company / CTC Proof

Role & responsibilities: Procurement/PR Raise Call from Reception for material receipt first confirm if material is free sample or against PR-PO, if yes then check PO NO in SAP and material send to concern department for further processing SAP Activities GRN SAP Activities Material code & Service Code Activities Stock Maintain in Excel Sheet Material Transfer to plant Preferred candidate profile Minimum 5+ years experience in Stores department good exposure of handling SAP MM and Vendor Negotiation.