299 Cmc Jobs - Page 3

Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufact...

Kotak Mahindra Bank Limited is looking for Location Sales Manager to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of n...

Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module Well versed with Regulatory guidance and Processes (i.e., Ability to understand and interpret technical expectations during review cycle) Clear Knowledge of basic aspects of a formulation (primarily pharmaceutical development) for effective review of R&D documents. Should be aware of post approval variation requirements. Should have basic QA knowledge to enable correct review of plant related documents

Position: RAD-US Market, (CMC, M3) Qualification: M. Pharmacy (Pharmaceutics, Regulatory Affairs) Experience: 6-11 yrs Job Location: Hyderabad Job Type: Permanent Responsibilities: Hands on experience with RA-US market ; responsible for Approved and Tentative Approved ANDAs /NDAs [i.e., filing of supplements (CBE, CBE-30, PAS, Response to Queries, Controlled Correspondence, Annual Reports** /Updates etc.,) Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, an...

Role & responsibilities: Job Shift: 1st, 2nd & 3rd Job title: Shift Engineer -3rd party payroll (ciel HR) Job Review: You will be ensuring that all technical services are maintained operational during your shift duty. Taking charge of entire technical assets in building, managing engineering team and supporting the Property Manager / Assistant Property Manager your team leader for coordinating for technical issues with client and occupants. Your key deliverables will be to: * Manage and maintain electromechanical / utilities services at the site with the help of technician team. * Prepare and implement planned preventive maintenance (PPM). * Conduct inspections at site regularly to check for...

Role & responsibilities Regulatory Submissions Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region. Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity. Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc) Regulatory Intelligence/Expertise/Guidance/Education Provide re...

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge o...

Role SAP BI/BW +BOBJ Senior Consultant Hiring Location: India (Delhi, Noida, Mumbai, Hyderabad) Responsibilities Document all technical and functional specifications for implemented solutions. Proficient in BW/B4H & ABAP/CDS with experience in the areas of Analysis, Design, Development Collaborate with clients to gather business requirements and translate them into BI/BW technical solutions. Interact with key stakeholders/support members in different areas of BW. Provide technical solutions to fulfil business requests using SAPs BW. Design, develop, configure, migrate, test and implement SAP BW 7.x data warehousing solutions using SAP BW, BW/4HANA, and related tools. Ensure data accuracy, in...

Job Descriptions CMC review of technical documentation for regulatory filings to various markets market: US- Gap Analysis and Remediation for module 3 -CMC Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN. Review of CTD dossiers , variations, change controls, renewals Affairs

Responsible for implementing CMC regulatory strategies for assigned products in accordance with global regulations and guidances; and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of regulatory milestones for less complex projects through the product lifecycle. Participate in the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects. Execution of CMC documentation including IND/CTA, NDA/BLA/MAA, post approval supplements, annual reports, registration renewals and responses to health authority questions per established business proces...

Should have exp in Regulated(EU /US) Pre-approval filings New marketing authorizations New dossier submissions to regulatory agency Review technical documents prepare Type IA /IB/II variations prepare submissions license variations & renewals Required Candidate profile Candidates having experience in Regulatory Affairs of Regulated Market should only apply Excellent written and verbal English communication sunil@flamingopharma.com,hr@flamingopharma.com

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, co...

Ensure compliance with GMP, FDA, and other regulatory standards Conduct quality checks on raw materials, in-process materials, and finished products Ensure compliance with regulatory requirements for drug development, manufacturing, and marketing.

REQUIRE EXPERIENCE IN MODULE 1 COORDINATION AND SUBMISSIONS. MAIN PURPOSE OF ROLE Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. MAIN RESPONSIBILITIES As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liai...

As a Regulatory Submission Specialist, your role involves handling the regulatory submission of new products, variations, and responses to queries for the US and OAM regions. Your primary responsibility is to prepare quality dossiers to ensure timely approvals for life cycle management. Key Responsibilities: - Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review various documents such as Development reports, scale-up reports, specifications, stability protocols, and analytical validations before initiating Exhibit batches. - Prepare responses to deficiencies to facilitate the approval of products filed with regulatory agencies. - Manage the ...

Company Brief- As India's largest manufacturer of forklift trucks, Godrej Material Handling offers an extensive range of forklifts, which include electric, LPG, and diesel counterbalanced forklifts up to 25 tonne capacity, warehouse trucks, and specialised trucks for specific applications. The business also designs and manufactures accessories to address a wide range of handling applications besides offering accessories made by specialists. The business offers lease, hire-purchase, and sale of pre-owned equipment as well as service maintenance programs through a network of 16 branches and over 45 dealers across India. The business exports to over 40 countries across Asia, the Middle East, Af...

Title: Production Manager VNC/VMC Department: Production Diploma / B.E. in Mechanical / Production Engineering. 10 - 12 years of experience in machining operations (VNC/VMC Contact - 9356395439 Email jobpune22#gmil.com Production Planning & Control Plan, schedule, and supervise daily VNC/VMC production activities. Ensure optimum utilization of manpower, machines, and materials. Monitor cycle times, tool life, and machine efficiency. Reduce setup times (SMED techniques). Implement Lean Manufacturing / 5S / Kaizen practices. Strong knowledge of CNC/VMC/VNC programming & operations. Experience in fixture design, tool selection, and process optimization.

Electrical Maintenance Engineer – Minimum 3+ years experience in VMC & CMC machine maintenance. Responsible for troubleshooting, preventive maintenance, and ensuring smooth machine operations.

Lead the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. Provide expert leadership overseeing both strategic and day-to-day activities in upstream process development of complex novel biologics. Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance. Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs). Scale-up process from laboratory-scale bioreactors to pilot and commercial-scale, ensuring process robust...

Skill requirement: Primary Skill -- Business Object 4.2 (Developer and Administrator), Web Intelligence / Crystal Reports, Universe design, CMC, CMS and Oracle PL/SQL Secondary Skill -- Windows, Unix scripts, Agile methodology Experience 6 to 9 years JD: To participate in report server configuration / upgrade and other SDLC activitiesincluding testing , deployment and support To be able to write new BO reports or modify existing BO report and also work along with other developers To manage the testing team for unit testing, system testing, integrated testing, UAT etc., To write the technical specification, functional specification, test plans and test scripts To coordinate with other team li...

Job Title: Sr. Manager / DGM Business Unit: Sun Global Operations Job Grade G9A/G8 Location : Gurgaon At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Key responsibilities: Serve as a Regulatory CMC Product Lead and provide CM...

As a Regulatory Affairs Manager, you will play a crucial role in monitoring the company's production activities to ensure compliance with all applicable regulations and standard operating procedures. Your responsibilities will include devising regulation compliance strategies, creating training and orientation programs for staff, conducting internal inspections and information drives, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of Chemistry, Manufacturing, and Controls (CMC) aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents ac...

Description Regulatory Manager (CMC, EU & Japan/China) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem so...

Description Regulatory Manager (CMC, EU & Japan/China) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem so...

Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and...