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 the USA, Canada, EU, UK, 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 Accounts & Finance professional for AGM / DGM role. This position is based at our Corporate Office at Nariman Point in Mumbai. The remuneration package will be commensurate with the incumbent’s professional experience and will be in line with market standards. Job Description: Overseeing all aspects of Financial Accounting including R2R, O2C, P2P. Ensure all financial operations adhere to generally accepted accounting principles (GAAP) and relevant laws and regulations. Lead financial audits, ensure accuracy of financial records and reports, and handle interactions with internal & external auditors. Overseeing and optimizing the company's cash flow, including forecasting, managing liquidity, and implementing strategies to improve cash utilization. Identifying, assessing, and mitigating financial risks, such as interest rate risk, foreign exchange risk, and credit risk. Building and maintaining strong relationships with banks and other financial institutions. Developing and implementing treasury strategies aligned with the company's overall financial objectives. Overseeing the selection, implementation, and management of treasury management solutions. Developing and maintaining compliance procedures and risk assessment frameworks, to ensure compliance with tax laws and regulations, and manage tax risks related to direct and indirect taxes (preferred). Handle inquiries and notices from tax authorities related to assessment/Audit/Return/Appeals/Rectification (preferred). To provide advice on tax planning and optimisation opportunities to ensure compliance with local regulations (preferred). Manage and develop a team of finance and accounting professionals, providing training, guidance, and support. Work collaboratively with other departments and stakeholders to ensure financial goals are aligned with broader business strategies. Preferred Education requirements : Chartered Accountant OR CMA. Required Skills: Deep understanding of financial principles, accounting practices, and financial analysis techniques. Ability to analyze financial data, identify trends, and develop solutions to financial challenges. Ability to communicate financial information clearly and effectively, and to work collaboratively with others. Ability to lead, motivate, and develop a team of finance professionals. Show more Show less
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. 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 AGM / DGM/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 organization’s 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
You will be working as a full-time on-site OSD Officer at UMEDICA Laboratories Private Limited in Indore. Your primary responsibility will involve overseeing the operational aspects of Oral Solid Dosage (OSD) manufacturing. This includes ensuring compliance with regulatory standards, supervising production processes, and managing formulation and granulation processes on a daily basis. Your tasks will entail coordinating with various departments to ensure a smooth workflow, maintaining thorough documentation for quality control and regulatory purposes, and ensuring that the manufacturing processes meet the required standards. Your role will be crucial in maintaining the efficiency and quality of OSD manufacturing at UMEDICA. To excel in this role, you should have experience with OSD manufacturing processes, including formulation and granulation. A strong knowledge of regulatory standards and compliance requirements is essential. Your ability to supervise production processes effectively, manage documentation efficiently, and communicate and collaborate with team members will be key to your success in this position. A Bachelor's degree in Pharmacy, Chemistry, or a related field is required for this role. Any prior experience in the pharmaceutical manufacturing industry would be advantageous. UMEDICA Laboratories Private Limited values innovation and continuous improvement, and as an OSD Officer, you will play a vital role in upholding these principles to meet global regulatory compliance standards.,
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 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. We are seeking a dynamic and experienced Manager/ Sr. Manager– Formulation Development Oral Liquid for our R&D Centre. This position is based at our R&D Centre at Turbe and will report to GM Formulation Development. The remuneration package will be commensurate with the incumbent’s professional experience and in line with market standards. Key Responsibilities: At least 8 years’ experience in formulation and development for oral liquid dosage form for with US & EU Should have done active contribution in liquid products development which includes identification of excipients, prototype formulation based in innovator product characterization Identification of right primary packaging components. Initiate stability batches with generating required GxP documents Candidate should have detailed understanding of scale up and EB manufacturing Should independently monitor and prepare formulation development documents like development report, MFC, specifications, tech transfer documents. Candidate should support for attending regulatory queries for US & EU market Should have in depth knowledge regarding excipients, its function and usage Other responsibilities: To execute product development activity as per requirements GMP need Support for scale up and EB batch activities Maintain laboratory environment as per GXP need, prepare SOP and develop systems In-depth understanding of regulatory agency requirements Should in-dependently handle plant pears Required Skills & Competencies: Technical expertise in Oral Liquid formulation Strong understanding of regulatory requirements : FDA, EMA, ICH guidelines, QbD, BCS-based biowaivers. Knowledge of intellectual property (IP) considerations in formulation design (FTF, PIV). Hands-on experience with formulation equipment and scale-up (granulators, compression, encapsulation, coating). Proficiency in data interpretation, scientific writing, and regulatory documentation. Qualifications & Experience: M.Pharm in Pharmaceutics , Pharmaceutical Sciences , or related field. 8 to 12 years of experience in formulation development of oral liquid dosage forms . Proven track record in technology transfer , global regulatory filings, and team leadership.
UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations including Injectables, Tablets, Capsules, Suspensions, Dry Syrups, etc. Our manufacturing facility, situated in Vapi (Gujarat), holds approval from global regulatory authorities. Founded in 1983, UMEDICA operates in over 85 countries across the globe, encompassing EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries. Upholding a culture of innovation & continuous improvement, we at UMEDICA constantly strive for excellence. We are currently looking for a dynamic and experienced Manager/ Sr. Manager specializing in Formulation Development for Oral Liquid products to join our R&D Centre located at Turbe. This role will directly report to the GM Formulation Development. The remuneration package will be competitive and aligned with the candidate's professional experience and prevailing market standards. Key Responsibilities: - Minimum 8 years of experience in formulating and developing oral liquid dosage forms compliant with US & EU regulations. - Actively involved in the development of liquid products, including excipient identification, prototype formulation based on innovator product characterization, and selection of primary packaging components. - Proficient in initiating stability batches and generating necessary GxP documentation. - Thorough understanding of scale-up and EB manufacturing processes. - Independent preparation of formulation development documents such as development reports, MFC, specifications, and tech transfer documents. - Support in addressing regulatory queries for the US & EU markets. - In-depth knowledge of excipients, their functions, and applications. Other responsibilities: - Execution of product development activities in adherence to GMP requirements. - Assistance in scale-up and EB batch operations. - Maintenance of laboratory environment as per GXP requirements, formulation of SOPs, and system development. - Comprehensive understanding of regulatory agency prerequisites. - Independent handling of plant operations. Required Skills & Competencies: - Expertise in Oral Liquid formulation. - Strong grasp of regulatory stipulations from FDA, EMA, ICH guidelines, QbD, and BCS-based biowaivers. - Knowledge of intellectual property considerations in formulation design such as FTF and PIV. - Hands-on experience with formulation equipment and scale-up processes including granulators, compression, encapsulation, and coating. - Proficiency in data interpretation, scientific writing, and regulatory documentation. Qualifications & Experience: - M.Pharm in Pharmaceutics, Pharmaceutical Sciences, or related field. - 8 to 12 years of experience in the formulation development of oral liquid dosage forms. - Demonstrated success in technology transfer, global regulatory filings, and team leadership.,
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 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 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.
Role Overview: UMEDICA is seeking an Accounts & Finance professional for the AGM / DGM role at their Corporate Office in Mumbai. As part of UMEDICA's expansion plans, you will be responsible for overseeing all aspects of Financial Accounting, ensuring compliance with accounting principles and regulations, managing cash flow and financial risks, building relationships with financial institutions, and developing treasury strategies in alignment with the company's financial objectives. Additionally, you will lead financial audits, manage a team of finance professionals, and collaborate with other departments to achieve financial goals. Key Responsibilities: - Oversee all aspects of Financial Accounting including R2R, O2C, P2P. - Ensure compliance with generally accepted accounting principles (GAAP) and relevant laws and regulations. - Lead financial audits, ensure accuracy of financial records, and handle interactions with auditors. - Optimize cash flow, forecast liquidity, and implement strategies to improve cash utilization. - Identify, assess, and mitigate financial risks such as interest rate, foreign exchange, and credit risks. - Build and maintain relationships with banks and financial institutions. - Develop and implement treasury strategies aligned with the company's financial objectives. - Select, implement, and manage treasury management solutions. - Develop compliance procedures and risk assessment frameworks for tax laws and regulations. - Provide advice on tax planning and optimization opportunities. - Manage inquiries and notices from tax authorities related to assessment, audit, return, appeals, and rectification. - Lead, motivate, and develop a team of finance and accounting professionals. - Collaborate with other departments and stakeholders to align financial goals with business strategies. Qualification Required: - Preferred Education: Chartered Accountant OR CMA. Additional Details: UMEDICA is a vertically integrated company with a global presence in over 85 countries, including the USA, Canada, EU, UK, Australia, Middle East, and more. Founded in 1983, UMEDICA is engaged in manufacturing and exporting a wide range of finished formulations and is known for its culture of innovation and continuous improvement.,
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 / Dy Manager Technology Transfer in technology transfer department. This position is based at our R&D center at Turbhe Navi Mumbai and will report to the GM Formulation Development. 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 7 to 10 years experience in the pharmaceutical industry handling technology transfer activities for oral liquid or injectable dosage form for US & EU market. Specifically, the incumbent will be responsible for: Experience in technology transfer activities for oral liquid or injectable dosage form for US & EU market Candidate should support for identification and selection of manufacturing facilities for solid, liquid and injectable dosage form for US & EU market Candidate should be aware of the GMP environment and regulated market requirements Should have manufacturing experience for auto injection products (Device, cartridge and PFS) Should have hand in development documents preparation like scale up report, EB report, PVR, summary report, MFC, MPC, specifications, vendor qualification, tech transfer documents Candidate should be aware regarding all scalability calculations To handle technology, transfer activities independently Monitor team and assign activities Ready to travel across India Understand the batch manufacturing process at R&D before moving ahead for plant batches Should visit the manufacturing facility and prepare feasibility report Should hold a qualified degree in pharmacy Should have idea in working with pharmaceutical industry tech transfer activity with minimum 10 years of experience Preferred Education requirements: Master’s in pharmacy.
Role Overview: As an Officer or Sr. Officer at UMEDICA Laboratories Pvt. Ltd., located in Vapi, Gujarat, you will be responsible for overseeing production activities in the pharmaceutical industry. Your role will involve ensuring compliance with regulatory standards, coordinating with various departments, maintaining detailed records, and actively participating in continuous improvement initiatives. Additionally, you will support the R&D team, ensure quality control, and assist with audits and inspections. Key Responsibilities: - Oversee production activities and ensure compliance with regulatory standards - Coordinate with various departments within the organization - Maintain detailed records of production processes - Participate in continuous improvement initiatives - Support the R&D team and ensure quality control - Assist with audits and inspections Qualifications: - Knowledge of regulatory compliance and manufacturing standards in the pharmaceutical industry - Experience in quality control, production processes, and record-keeping - Strong communication and coordination skills - Proficiency in problem-solving and continuous improvement methodologies - Ability to work on-site in Vapi, Gujarat - Bachelor's degree in Pharmacy, Chemistry, or a related field - Prior experience in a pharmaceutical manufacturing environment is a plus - Familiarity with global regulatory standards such as US FDA and EU regulations,
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 Manager / Sr Manager Regulatory Affairs– US Markets in Regulatory Affairs department. 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 incumbent’s professional experience and will be in line with market standards. Key Responsibilities: Regulatory Submissions: Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDA Manage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports) Ensure compliance with current USFDA regulations and guidance documents FDA Interactions: Prepare and submit FDA meeting requests and meeting packages (Type B, C meetings) Participate in and support FDA meetings as the regulatory lead Handle Controlled Correspondence with the FDA for product development and regulatory strategy Product Expertise: Provide regulatory support for complex formulations , including injectables and liquid dosage forms Collaborate with R&D, QA, QC, and manufacturing teams to ensure regulatory alignment throughout the product lifecycle Leadership & Communication: Lead a team of regulatory professionals, providing guidance, training, and performance management Communicate effectively with internal stakeholders and external regulatory bodies Qualifications & Experience: Master’s degree in Pharmacy 13–15 years of experience in US Regulatory Affairs with a proven track record in ANDA/NDA submissions Hands-on experience with FDA meetings, Controlled Correspondence, and post-approval changes Strong understanding of injectables, liquid dosage forms, and complex generics Excellent written and verbal communication skills Demonstrated leadership and team management capabilities
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 Manager / Sr Manager Regulatory Affairs– Emerging Markets in Regulatory Affairs department. 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 incumbent’s professional experience and will be in line with market standards. Role & responsibilities: Regulatory Strategy & Planning: Develop and implement strategic plans for regulatory submissions and ongoing compliance. Submission Management: Oversee the preparation and submission of regulatory applications and amendments to relevant agencies. Agency/Customer Interaction: Serve as a primary point of contact with customer/regulatory authorities, representing the company. Lifecycle Management: Manage the regulatory lifecycle of approved products, including handling post-approval changes, supplements, and annual renewals. Documentation & Reporting: Critically review and approve all regulatory documents for accuracy, completeness, and adherence to regulatory standards. Audits & Inspections: Coordinate and support company activities during regulatory agency audits and inspections. Team Leadership & Collaboration: Guide and mentor junior staff, manage multiple projects simultaneously, and collaborate with internal cross-functional teams and external counsel. Required Skills & Qualifications: Education: Bachelor’s or master’s degree in pharmacy (B. Pharm, M. Pharm). Experience: 13-15 years of experience in regulatory affairs, with emerging market experience Technical Expertise: Deep understanding of CMC documentation (Chemistry, Manufacturing, and Controls) and the product development process. Communication: Excellent written and verbal communication skills for internal coordination and external agency interactions. Problem-Solving: A solution-oriented mindset with a capability for risk assessment and mitigation.
You will be joining UMEDICA, a vertically integrated company involved in manufacturing and exporting a wide range of finished formulations globally. The company's manufacturing facility in Vapi, Gujarat, is approved by global regulatory authorities. UMEDICA, established in 1983, operates in over 85 countries worldwide, including prominent markets like the USA, Canada, EU, UK, Australia, Middle East, and more. As part of our expansion plans, we are seeking an Assistant Manager / Manager with a strong background in Packaging to join our R&D center in Turbhe, Navi Mumbai. In this role, you will directly report to the Head of Formulation Development. Your responsibilities will include: - Developing packaging material for solid, liquid, and injectable dosage forms for the US & EU markets - Evaluating innovator products and selecting appropriate packaging materials - Identifying vendors of packaging material that meet regulated market standards - Selecting devices, cartridges, and PFS for auto-injection products - Preparing packaging development documents such as development reports, MPC, specifications, vendor qualifications, tech transfer documents, secondary packaging selection, and desiccant selection - Selecting packaging machines for product packing and conducting MOC characterization & inline material screening In addition, you will: - Assist in product development activities related to packaging materials - Monitor team members and assign tasks - Provide support for scale-up and EB batch packaging activities - Ensure the laboratory environment complies with GXP standards, develop SOPs, and establish systems - Generate ideas for new dosage forms To be successful in this role, you must: - Hold a qualified degree in packaging development - Have a minimum of 10 years of experience working in pharmaceutical industry development activities - Preferably possess a Bachelor's degree in pharmacy or a related science discipline. Candidates with a post-graduation degree (e.g., MBA) will be given preference. Your remuneration package will be competitive and aligned with your professional experience, in accordance with market standards.,
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 the USA, Canada, EU, UK, 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. This position is based at our Corporate Office at Nariman Point in Mumbai and will report into the President. 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 between 10-15 years of experience responsible for overseeing and managing day-to-day operations related to Logistic and shipment within logistics. The role focuses on ensuring timely, cost-effective and compliant delivery of shipments while maintaining strong relationships with carriers, brokers, and internal stakeholders. Specifically, the incumbent will be responsible for: Manage end-to-end logistic operations, including load planning, dispatch, and tracking. Responsible for Planning and executing Air, Sea and by Road shipment to match the committed delivery date. Coordinate with clearing, forwarder and nomination agent for custom and planning the Shipment. Monitor shipment status, handle exceptions, and provide timely updates to customers and internal teams. Negotiate rates and ensure cost optimization while maintaining service quality. Ensure compliance and company policies. Analyze operational performance and provide recommendations for continuous improvement. Maintain accurate documentation and records for audit and reporting purposes. Preparations of pre and post shipment documents for export dispatch to overseas parties (as per letter of credit) for submission to the bank. Approving all customs-related documents, such as the Checklist, BL Draft, and Approving COO draft. Payments follow-up with the account team for vendors. Preparation of documents for inward remittance and generating e-BRC from the DGFT portal. Post export DGFT work, such as application of Road tap, EPCG license closure procedure. Drawbacks of receivables follow-ups from customs. Self-letter drafting for custom purposes/ Bank purposes Need Knowledge of Advance license and import procedures. All day-to-day work is assigned by the manager. Required Skills & Qualifications: Bachelor’s degree (preferred) in Supply Chain, Logistics, or a related field 10–15 years of experience in logistics operations Experience with SAP Knowledge of freight services (Air, Ocean, Road, Import, Export, LCL/FCL). Strong communication and interpersonal skills. Proficiency in MS Office (Excel, PowerPoint, Outlook); experience with SAP system preferred. Ability to multitask, prioritize, and work under tight deadlines. Attention to detail and a proactive attitude. logistics environment (preferred) Strong knowledge of logistic operations, airline / shipping line cargo booking and freight movement processes Good understanding of carrier and broker coordination Ability to plan and monitor loads effectively (dispatch, tracking, exception management) Excellent communication skills for dealing with carriers, drivers, brokers, and internal teams Negotiation skills for rate discussions with carriers/brokers Problem-solving ability to manage delays, service failures, and escalations Proficiency in MS Office (Excel, Outlook) and SAP Preferred Attributes: Experience working in logistics, freight forwarding, or supply chain companies Ability to work independently and manage multiple tasks with accuracy A proactive attitude towards learning and process optimization Experience in coordinating with overseas agents and international clients. Familiarity with Incoterms and customs regulations
As a Manager/Sr Manager Regulatory Affairs Emerging Markets at UMEDICA, you will play a crucial role in the Regulatory Affairs department at our R&D center in Turbhe Navi Mumbai. Your primary responsibility will be to develop and implement strategic plans for regulatory submissions and ensure ongoing compliance. Your role will involve overseeing the preparation and submission of regulatory applications and amendments to relevant agencies. You will also serve as the primary point of contact with customers/regulatory authorities, representing the company. Key Responsibilities: - Develop and implement strategic plans for regulatory submissions and ongoing compliance. - Oversee the preparation and submission of regulatory applications and amendments. - Serve as the primary point of contact with customer/regulatory authorities. - Manage the regulatory lifecycle of approved products, including post-approval changes and annual renewals. - Critically review and approve all regulatory documents for accuracy and completeness. - Coordinate and support company activities during regulatory agency audits and inspections. - Guide and mentor junior staff, manage multiple projects, and collaborate with internal teams and external counsel. Qualifications Required: - Education: Bachelors or masters degree in pharmacy (B. Pharm, M. Pharm). - Experience: 13-15 years of experience in regulatory affairs, with emerging market experience. - Technical Expertise: Deep understanding of CMC documentation and the product development process. - Communication: Excellent written and verbal communication skills for internal coordination and external agency interactions. - Problem-Solving: Solution-oriented mindset with a capability for risk assessment and mitigation. UMEDICA, a vertically integrated company founded in 1983, is engaged in manufacturing and exporting a wide range of finished formulations. With business operations in over 85 countries, UMEDICA fosters a culture of innovation and continuous improvement. The company's manufacturing facility in Vapi, Gujarat, is accredited by global regulatory agencies, including EU, PICs, Local FDA, and USFDA inspected. Join us as we expand and grow, offering a remuneration package commensurate with your professional experience and market standards.,