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.
Walk-In Interview Date : 03rd August 2025 (Sunday) Timing : 9.00 AM to 2.00 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 Qualification Activities of equipment & Utility Position: Sr.Officer to Executive Qualification: B.Sc / M.Sc. / B.Pharm / M.Pharm Experience: 3 to 8 years No. of Vacant Position: 02 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. No. of Vacant Position: 02 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 9. Engineering & Maintenance Department: (Should have Exposure of trouble shooting of Injection Vial Washing M/c, Dry Powder Filling m/c Ampolue & Liquid Filling, DH6,Bung Processor, Autoclave ETC, Having Sound Knowledge of PLC Scada Instrument OSD Manufacturing/Packing machine/ Hvac/Plant Maintenance, Handling of projects, QMS- activity, known to EHS Activity Also. Position: Officer to Sr. Officer Qualification: B.E/ M.E Experience: 1 to 5 years No. of Vacant Position: 5 Position: Technical Associates (Operator) Qualification: ITI / Diploma Experience: 2 to 5 years No. of Vacant Position: 05 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 Perform FTO, patent landscape, prior art & patentability searching in various scientific and commercial patent databases (such as scifinder and other key word based search engines). Analyze patents related to formulations and identify potential IP risks or opportunities. Assist in developing non-infringing strategies during formulation development stages. Monitor competitor patent activity and relevant patent expiries. Devise search strategies, perform searches, categorize and analyze the results, and prepare timely reports Collaborate with formulation and regulatory teams to ensure IP compliance in product development. Maintain accurate records of IP evaluations and documentation. Support the IP team in preparing documentation for patent filings, oppositions, or litigation, as needed. Track key blocking patents / applications and advise on relevance. Communicate and coordinate with cross functional teams. Provide patent expiry dates to business for new product identification. Work as a part of IP team to provide business with timely, accurate information about patents. Preferred candidate profile Post Graduate in Pharmacy or related science. A Diploma in IPR is an added advantage Good knowledge of patent law Experience in working for developed (US/Europe/Canada) as well as emerging markets Excellent technical knowledge in the Pharma domain Excellent understanding of pharmaceutical dosage forms and API Excellent understanding of patent search databases Patent drafting/prosecution experience a plus Excellent oral and written communication skills. Willingness to learn and develop new skills Self-motivated and detail-oriented Excellent team member Proficient in Microsoft Word, Excel, and Powerpoint applications
UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Injectables, Tablets, Capsules, Suspensions, Dry Syrups, etc. UMEDICA's manufacturing facility, located in Vapi (Gujarat), is approved by global regulatory. UMEDICA was founded in 1983 and has business operations in more than 85 countries including USA, EU, UK, 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. We are seeking a dynamic and experienced Head of Portfolio Management. This position is based at our Corporate Office at Nariman Point in Mumbai and will report into the Managing Director and VP International Business. The remuneration package will be commensurate with the incumbent’s professional experience and in line with market standards. Essential skills and experience: The incumbent must have at least 8 to 10 years of experience in the pharmaceutical industry, with core expertise in portfolio management for all regulated and semi-regulated markets within our Finished Formulations Business. Identifying new molecules for selection and building the portfolio roadmap with a particular focus on CGT and early market entry opportunities, 505b2, complex generic formulations across USA, EU and UK markets Skilled in Pharmaceutical research including evaluation of Intellectual Property (IP) and clinical trial data Ability to evaluate the commercial value of a product by analysing the yearly USA and EU Sales and Volume data trend, identifying competitors, etc. Understanding in development of solid orals (tablets, capsules) and injectable formulations, literature search, patent search, documentation, scientific writing Engage with Business development function, IP, RA and senior management team to devise and update company’s product portfolio from time to time Managing of existing portfolio i.e., conduct a periodic review of products in pipeline with cross functional teams to review projections, IP, development timelines, and strategy. Preferred Education requirements: Bachelor’s or Master’s in Pharmacy. Candidates who has completed an MBA will be preferred.
UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Injectable, Tablets, Capsules, Suspensions, Dry Syrups, etc. UMEDICA's manufacturing facility, located in Vapi (Gujarat), is approved by global regulatory. 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 an aggressive and dynamic General Manager/Sr General Manager of Intellectual Property (IP) will lead and manage all IP functions of the organization, including patent drafting and filing, prosecution, litigation monitoring, patent review, and part of portfolio management team. The incumbent will be responsible for developing a global IP strategy that aligns with business and R&D goals, ensuring the organizations innovations are well protected, and enabling competitive advantage in the pharmaceutical industry. This is a senior leadership role requiring deep technical and legal expertise and strong cross-functional collaboration. This position is based at our R&D center at Turbhe Navi Mumbai and will report to the CSO The remuneration package will be commensurate with the incumbent’s professional experience and will be in line with market standards. Key Responsibilities: 1. IP Strategy Development & Leadership Define and implement the global IP strategy in alignment with business and product life-cycle goals. Act as the key advisor to executive management on IP-related risk, opportunity, and value creation. Represent IP in strategic business decisions including R&D, regulatory submissions, licensing, partnerships, and M&A. 2. Patent Filing & Drafting Evaluate invention disclosures and determine patentability and commercial potential. Oversee or directly draft patent applications, including provisional, PCT, and national phase filings. Coordinate with inventors, scientists, and R&D teams to ensure comprehensive and accurate patent coverage. Ensure timely preparation and submission of filings to avoid loss of rights. 3. Patent Prosecution Manage the prosecution process across major jurisdictions (USPTO, EPO, IPO India, CNIPA, JPO, etc.). Review and respond to office actions, examiner reports, and pre/post-grant oppositions. Guide external counsel on prosecution strategies that maximize protection and minimize cost. Ensure compliance with procedural deadlines and track legal status of applications. 4. IP Portfolio Management Build, maintain, and optimize the global IP portfolio (patents, trademarks, designs). Conduct regular audits of the portfolio to ensure strategic alignment and cost-effectiveness. Categorize IP assets based on technology type, therapeutic area, priority, and revenue contribution. Identify gaps in protection and proactively file new applications. Implement patent family management and life-cycle strategies including SPCs, PTEs, and extensions. Monitor annuity payments and renewal deadlines with internal or third-party IP management systems. 5. Patent Review & Competitive Intelligence Perform detailed freedom-to-operate (FTO) and landscape analysis to support new product development and market entry. Conduct patent validity/infringement analysis for internal innovation and third-party products. Monitor competitor IP filings and identify white space or blocking patents. Provide reports and alerts to R&D and management regarding emerging threats or opportunities. 6. IP Litigation Management Monitor and manage all IP-related litigation, including: Paragraph IV ANDA litigation (for generics) Patent oppositions (India, EPO, US) Trade secret or trademark disputes Develop legal strategies in collaboration with external counsel. Assist with evidence gathering, expert selection, and claim construction. Support pre-litigation risk assessments and alternative dispute resolution (ADR) strategies. 7. IP Transactions & Due Diligence Lead IP due diligence for: In-licensing and out-licensing of technology Joint ventures and collaborations Product acquisitions and divestitures Draft and review IP-related clauses in agreements (e.g., licensing, MTAs, CDAs, co-development contracts). Ensure proper assignment of IP rights from employees, consultants, and research partners. 8. Compliance, Policy & Training Ensure compliance with international IP laws, patent office procedures, and regulatory IP linkage systems (e.g., Orange Book listings). Develop internal IP policies and SOPs for invention disclosure, confidentiality, and data protection. Train R&D and business teams on IP awareness, documentation, and competitive behavior. Monitor potential misappropriation of trade secrets or proprietary data. Required Qualifications: Educational Background: M.Pharm, M.Sc., PhD in Chemistry, Biotechnology, Pharmacy, or related life sciences field. Law degree (LLB or LLM) or qualification as a Registered Patent Agent (India/US/EU) preferred. Professional Experience: Minimum 15– 18 years of experience in pharmaceutical IP, with at least 10 years in a senior leadership role. Extensive hands-on experience in patent drafting, prosecution, FTO, portfolio management, and litigation. Proven ability to manage IP assets for generic, branded, 505 b2 , Oral solids, Injectables and Liquids product know how is must. Key Skills & Competencies: In-depth knowledge of patent law , regulatory exclusivities , and pharma R&D processes . Strong command of tools like Derwent Innovation, PatBase, Orbit, USPTO/EPO databases, Scifinder, IPD analytics . Excellent communication and negotiation skills. Strategic thinker with a strong commercial orientation. Ability to manage teams and external legal/IP partners. Experience with IP management systems (e.g., Anaqua, CPA Global, IPfolio). Preferred Attributes: Experience with global markets including US, EU, India, China, Brazil, and Japan . Familiarity with SPC, PTE, data exclusivity , and patent term restoration. Leadership in managing multi-country litigation or opposition cases. Know how of IP assessment of finished products must, API will be additional advantages
Walk-In Interview Date: 3rd,4th & 5 September 2025(Wednesday , Thursday & Friday) Timing: 09:30 A.M. to 4:00 P.M. Venue: Umedica Laboratories Pvt. Ltd. Plot No. Plot No. 221 & 221/1,GIDC, IInd Phase Vapi 396195 ,Gujarat 1. Quality Control Position: QC Officer Candidates having educational qualification of BSc/MSc with specialization in Chemistry. Organic chemistry/Analytical chemcistry with experience of 2 to 5 years in Quality control Departments. Working exposure in HPLC, GC, etc. Qualification: M.Sc. Chemistry / BSc. Experience: 2-5 Years No. of Vacant Position: 20 2. Engineering Position : Officer / Sr. Officer / Executive Should Have Sound Knowledge of PLC Scada Instrument have related to Mfg Area (Osd, Injection), Plant Maintenance, Utility area & EHS Activity. Qualification : B.E / B. Tech - Mechanical Experience : 3 - 8 Years No. of Vacancies : 05 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 & Bank Statement (Last 3 Months )
FIND ON MAP