74 Ema Jobs

Role Overview: As a Manager- Regulatory Affairs-International, your primary purpose will be to manage and oversee the preparation, review, and timely submission of regulatory dossiers in CTD and ACTD formats for international markets. You will ensure ongoing regulatory compliance and support product lifecycle management across ROW and emerging markets. Key Responsibilities: - Prepare and review Common Technical Document (CTD) and ASEAN Common Technical Document (ACTD) dossiers. - Coordinate with manufacturing sites and R&D to gather necessary data and documents for regulatory submissions. - Ensure plant compliance with regulatory requirements and facilitate timely implementation of changes. ...

Job Title: Executive / Senior Executive Regulatory Affairs (API) Location: Noida or Hyderabad, India Job Type: Full-Time Role Overview: We are seeking a motivated and detail-oriented Regulatory Affairs Professional to join our API regulatory team. The candidate will be responsible for preparing and reviewing eCTD sections of regulatory submissions (ASMF/CEP) and data packages for European markets, ensuring compliance with international regulatory standards. Key Responsibilities: Coordinate with cross-functional departments to arrange required technical data for ASMF/CEP and technical package preparation . Review quality and manufacturing data for APIs for regulatory adequacy as per relevant ...

Job Title: Senior Trainer Validation (CQV, Equipment, Injection Mold, HVAC) Location: Remote Job type: Part-time Job Summary: To design, develop, and deliver comprehensive training programs on Commissioning, Qualification & Validation (CQV), Equipment Qualification, Injection Molding Process Validation, and HVAC System Validation. The trainer will ensure technical competency development across engineering and quality teams in compliance with international regulatory standards (USFDA, EU GMP, ISO 13485, etc.). Key Responsibilities: Develop and deliver training modules on: Commissioning, Qualification, and Validation (CQV) lifecycle Equipment Qualification (IQ/OQ/PQ) Process Validation for Inj...

Role Overview: You will be leading the Quality and Regulatory department of the API and Intermediate business at LOXIM. Your primary focus will be on ensuring quality, compliance, and global regulatory excellence, with a hands-on approach. You are expected to align with cGMP, ICH, and international regulatory standards, strengthen systems, people, and culture. Your deep understanding of API and intermediate processes, global filing requirements, and ability to guide teams through audits, inspections, and technology transfers will be crucial. Key Responsibilities: - Lead QA, QC, Regulatory Affairs, and Compliance functions at all manufacturing sites. - Ensure alignment with cGMP, ICH Q7, and ...

As a Quality Control Compliance Reviewer at Amneal, you will be responsible for ensuring cGMP compliance in the QC laboratory. Your key responsibilities include: - Reviewing the completeness of analytical documents and approving the Certificate of Analysis (CoA) for Raw materials, packaging materials, In-process, finished products, stability studies for submission, validation, and commercial batches. - Performing/reviewing investigations for Quality issues such as Out of Specification (OOS), Deviations, Incidents, Corrective and Preventive Actions (CAPAs) related to laboratory. - Ensuring implementation of CAPAs recommended in OOS, Out of Alert Limits (OOAL), Incidents, and deviations in the...

As a Plant Head / Chief Operating Officer (COO) - Oral Solid Dosage in Ahmedabad, your primary role will be to lead strategic growth, operational excellence, and regulatory compliance in a regulated industry. You will report to the Board and play a crucial part in expanding the company's market presence. **Key Responsibilities:** - Define, communicate, and implement business strategy aligned with growth goals - Oversee daily operations, drive efficiency, and ensure financial discipline - Lead regulatory, licensing, and compliance efforts (e.g. GMP, USFDA, EMA) - Build and mentor a high-performing leadership team - Act as a company spokesperson and engage with investors, regulators & Board **...

As a Safety Specialist I at Precision, you will play a crucial role in the safety team by handling all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and post-marketing safety programs. Your responsibilities will include: - Processing ICSRs following Standard Operating Procedures (SOPs) and project/program-specific safety plans - Triage and evaluation of ICSR data for completeness, accuracy, and regulatory report ability - Entering data into the Argus Safety Database - Coding events, medical history, concomitant medications, and tests - Drafting case narratives - Assessing information for queries and ensuring satisfactory re...

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace ...

As a Production Planner in a pharmaceutical manufacturing environment, your role involves developing and managing efficient production schedules to meet demand forecasts, optimize resource utilization, ensure compliance with GMP and regulatory standards, and minimize downtime. Your key responsibilities include: - Developing and maintaining detailed production plans based on sales forecasts, inventory levels, and customer orders. - Coordinating with procurement, quality assurance, warehouse, and manufacturing teams to align production plans. - Monitoring production progress and adjusting schedules as necessary to avoid delays and ensure timely product delivery. - Ensuring planning aligns with...

Role Overview: Working at Bristol Myers Squibb is a unique and rewarding experience where you will have the opportunity to engage in meaningful work that impacts the lives of patients worldwide. As a Computer System Validation Lead in the Digital Manufacturing EMES team, you will play a crucial role in ensuring compliance and validation for the Manufacturing Execution System (Syncade) to support BMS" global manufacturing operations. This position offers the chance to work with high-achieving teams and grow through diverse opportunities uncommon in scale and scope. Key Responsibilities: - Develop and implement the test automation strategy, aligning with project goals and timelines. - Design, ...

Job Title: Formulation Manager - Pharma for Generic Market Support Location: Mumbai, India About the Role: We are seeking a Formulation Manager with hands-on experience in generic and super generic formulations. This role will lead laboratory operations, manage technical support, and collaborate with cross-functional teams to support pharmaceutical applications across Asia Pacific, Latin America, and the Middle East. Responsibilities: Oversee formulation development and technical support for pharmaceutical applications in regulated markets. Collaborate with business development and R&D teams to enhance pharmaceutical formulations. Provide scientific support to internal teams, distributors, a...

,in-processthe ,for leading,for leading,problem-solvingResponsibilities We are looking for a senior professional AGM with a range of 15 to 20 years of experience in Analytical Method Validation for regulated markets. The role involves leading API and excipient method validation across multiple dosage forms and managing a team of 30, including three senior managers. The ideal candidate must be technically strong, experienced in US/EU compliance, and hold an M. Pharm, M.Sc., or Ph.D. Role & responsibilities: Accountable to lead the team for AMV of OSD, Nasal, Injectables, Ophthalmic and Topical dosage formulations. Responsible for RM & PM characterization and documentation. Generate qualificat...

JD:- We have an exciting role of Submission Specialist (MLR+EMA) to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. About US We are an integral part of Annalect Global and Omnicom Group, one of the largest media and advertising agency holding companies in the world. Omnicoms branded networks and numerous specialty firms provide advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations, and other specialty communications services. Our agency brands are ...

Job Summary Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems. Key Responsibilities Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations. Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner. Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulat...

Regulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profile BSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier prep, submission processes, documentation, compliance, MS Office, attention to detail & communication skills.

Regulatory Affairs Hiring Profile eCTD Specialist Experience Level: 3 to 6 Years Location: Work from office (Hyderabad) Skills & Qualifications: 1.Education: Bachelor's or Masters degree in Life Sciences, Regulatory Affairs, or related field. 2.Experience: 3 to 6 years of experience in regulatory affairs with a focus on eCTD submissions, preferably in the pharmaceutical or biotechnology industry. Role Overview: With 3 to 6 years of experience in regulatory affairs, this role requires expertise in eCTD submission software, strong knowledge of global regulatory standards, and the ability to troubleshoot and improve submission processes. The specialist will ensure compliance with evolving regul...

Job Title: Calibration & Validation Trainer Pharma Industry Location: Remote Job type: Part-time Job Summary: We are seeking an experienced Calibration & Validation Trainer with 10+ years of expertise in pharmaceutical quality systems, equipment calibration, and validation practices . The role involves delivering high-impact training programs to professionals and fresh graduates, focusing on regulatory compliance, instrumentation, validation protocols, and audit readiness . The trainer will act as both a technical instructor and career enabler , ensuring participants gain hands-on knowledge aligned with industry standards (FDA, cGMP, ISO, ICH, GAMP5, 21 CFR Part 11). Key Responsibilities: De...

Job Title: Sr. Executive/Executive Department: DQA Job Summary, Duties/Responsibilities: Ensure proper guidance on quality issues to the Product Development Teams Review the documents received from R&D, AR&D, etc. so that the same can be shared with authorities and customers . coordination communication and to respond customer complaint/query and regulatory authority. Review the process change proposals and help the team members provide guidance on change proposals Review the in-house expert reports/Quality overall summary (QOS) prepared by the team members Ensure proper stage gate compliance at various stages of product development Ensure that internal audits are conducted properly Review t...

Location: Ahmedabad Qualification: M.Sc./Ph.D. (Organic Chemistry) Experience: 0-6 months Job Description: Assist senior scientists in carrying out experiments related to API, CRO, and CDMO projects. Perform basic laboratory activities such as reaction setup, sample preparation, and documentation. Support in maintaining lab safety standards, equipment handling, and record keeping. Learn and apply analytical techniques under guidance. Skills Required: Strong academic knowledge of Organic Chemistry. Willingness to learn API process research and development. Good communication and documentation skills. --- 2. Executive / Sr. Executive R&D (API/CRO/CDMO) Location: Ahmedabad Qualification: M.Sc./...

Role : Senior Clinical Data Manager Location : Chennai, Tamil Nadu Experience : 10-15 Years Requirements: 10-15 years of experience in clinical trial/data management and data operations. Minimum 4-5 years of people management (preferred) experience with proven supervisory skills. Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar). Strong background in EDC systems management and clinical data operations. Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas. Technical Expertise: CTMS configuration and administration skills (Having knowledge in CRIO is an advantage). Deep knowledge of EDC platforms and system integ...

Job Description Summary As Customs & Global Trade Team Leader , you will provide detail oriented and proactive support for international trade operations. This role ensures compliance with global customs regulations and supports smooth import/export processes for pharmaceutical products. Key responsibilities will include: 1. Team Management Effective in resource management skills, ability to synthesize disparate information, and build consensus, has sound judgment and decision-making Good interpersonal, leadership, and team player skills Excellent oral, written, presentation and communication skills Quality Orientation and ability to take initiative and demonstrate ownership of problem resol...

Job Title: Manager / Sr. Manager Sales & Marketing (APIs) Location: Vashi, Navi Mumbai Department: Sales & Marketing Reporting To: Marketing Head About Us Calyx Chemicals & Pharmaceuticals Ltd. is a leading manufacturer and supplier of Active Pharmaceutical Ingredients (APIs). With a strong global presence and focus on innovation, we are committed to delivering high-quality pharmaceutical solutions while ensuring compliance with international standards. Key Responsibilities Develop and execute strategic sales & marketing plans to drive revenue and business growth. Identify new business opportunities in domestic & international API markets. Monitor market trends, competitor activity, and regu...

Position Summary The Safety Specialist I is an integral part of the safety team at Precision and performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs. Essential functions of the job include but are not limited to: Process ICSRs according to Standard Operating Procedures (SOPs) and project/program- specific safety plans Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability Enters data into Argus Safety Database Code events, medical history, concomitant medications and tests. Draft case narratives Assesses information to be queried and follows ...

Manage the technology transfer process for established products, ensuring robust and compliant manufacturing processes e.g. implementation of new API sources. Write, review, and maintain regulatory response documents, justification reports, and risk assessments related to technology transfer activities. Oversee the preparation and review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for smooth transfer and manufacturing. Review process validation protocols and reports. Coordinate with R&D, production, quality assurance, and regulatory teams to ensure alignment on project deliverables and timelines. Troubleshoot and optimize manufacturing processes addressing deviatio...

As a Strategic Partner Manager, WSG (Solutions Architecture) on Dell Technologies Direct Sales Team in Bangalore/Mumbai, your role is crucial in building strong customer relationships and ensuring exceptional customer experiences with existing and potential clients. Key Responsibilities: - Consult with external customers to implement new IT solutions or replace existing ones - Develop and offer end-to-end IT solutions that align with customers" strategic, operational, and financial goals - Translate clients" business and technical requirements into specific system, application, or process designs for complex technology solutions - Lead Intel Technology for OSE & SE organization in CSG, drivi...