299 Cmc Jobs - Page 6

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...

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...

As a Regulatory Manager, Delivery, CMC Small Molecules Mature Products at GSK, you will play a pivotal role in leading a team dedicated to ensuring the continuous supply of essential medicines through the delivery of high-quality regulatory dossiers. Your contributions will directly impact patient care on a global scale, offering you the opportunity to collaborate with a diverse range of stakeholders, drive process enhancements, and uphold regulatory excellence. If you are proactive, detail-oriented, and enthusiastic about leadership in the realm of regulatory affairs, this position is tailored for you. Your primary responsibilities will encompass leading and nurturing your team to cultivate...

Senior Resident/ Assistant Professor in CMC Chittoor Campus (Orthopaedics) Qualification: MS (Orthopaedics). Experience: Should have at least one year teaching exp. as (Asst. Professor) in any NMC recognized teaching institution for applying Assistant Professor post. Salary: As per institutional Rule Accommodation Provided(subject to availability)

Demonstrated experience in authoring and review of Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines Strong experience in assessing the change control issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy. Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative and technical component...

Job Summary : Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations: a. Prepare and review variation ...

Eurofins Scientific through its subsidiaries is a world leader in food, environment, pharmaceutical and cosmetic product testing, discovery pharmacology, forensics, advanced material sciences, and in agroscience Contract Research services. It is also one of the global independent market leaders in genomics and in the support of clinical studies, as well as in BioPharma Contract Development and Manufacturing. In addition, Eurofins is one of the key emerging players in specialty esoteric and molecular clinical diagnostic testing in Europe and the USA. With ca. 62,000 staff across a network of over 1,000 independent companies in 62 countries and operating over 900 laboratories, Eurofins offers ...

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inc...

Job description for Asst. Manager/Sr. Executive - Regulatory Affairs Department (USA market) Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIA Report to : Manager, Regulatory Affairs, Nivagen Pharmaceuticals Job Description: 1. Develops and implements submission strategies for PIND, 505(b)(2); NDAs; ANDA. 2. Leads and ensures implementation of the planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2; ANDA submissions including FDA meeting requests and packages. 3. Critically reviews and approves documentation from clinical development, non-clinical development, iPSP, Research and Development (R&D), Quality, Technical Operations, Lab...

Job description for Executive / Officer - Regulatory Affairs Department (USA market) Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIA Report to : Manager, Regulatory Affairs, Nivagen Pharmaceuticals Job Description: 1. Compilation of various applications like CC / CGT / iPSP / PIND packages. 2. The planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2/ANDA/PAS submissions including FDA meeting requests and technical DS, DP and Clinical packages. 3. Compilation and review of Labeling and SPLs for NDA/ANDA/PAS applications. 4. Review and compilation of DMF sections for NDA/ANDA/PAS filing. 5. Ensures that project timelines are develop...

1. Utilise all radiographic equipment to perform X-rays, C-arm, Ultrasound and Mammography. 2. Capable of interpreting and diagnosing from the images. 3. Support the customer in repairing and maintaining the equipment. 4. Troubleshoot and install

Regulatory Affairs CMC Experience: 6-11 years Education: Science Graduate Location: Hyderabad Skills: Regulatory Affairs, US market, CMC

Roles and Responsibilities Manage procurement activities for medical equipment, including capex purchase orders. Conduct vendor negotiations to secure best prices and terms. Create POs (Purchase Orders) according to company policies and procedures. Ensure timely delivery of goods by coordinating with internal audit team. Communicate effectively with stakeholders throughout the procurement process. Desired Candidate Profile 2-4 years of experience in procurement, preferably in a healthcare setting. Strong understanding of AMCS (Asset Management Configuration System), CAPEX purchase processes, and communication skills. Ability to create accurate POs using CMC (Capitalisation & Maintenance Cost...

JOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: • Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements • Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained pe...

. Critical Care Therapist (Term Appointment) for the Medical Critical Care Qualification: B.Sc., Critical Care Technology from any recognised University or Diploma in Critical Care Therapy obtained from CMC Hospital (H.Sc., with Two Year Diploma with one year internship). Consolidated Pay: As per institutional rules. Job Description: To look after ICU Equipment and to assist with the care of critically ill patients. Note: Only Regular mode will be accepted, Private or correspondence will be not accepted.

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : SAP UI5 Development Good to have skills : NA Minimum 2 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. You will be responsible for ensuring that the applications are developed according to specifications and delivered on time. Your typical day will involve collaborating with the team to understand the requirements, designing and dev...

Immediate requirement for Executive - Regulatory function for one of the leading pharma company Position : Executive ( Regulatory function ) Educational qualification: MSc/MPharm Experience : 3 to 6 years of relevant experience. CTC : up to 6 LPA Contract Period: 1 Year (It can be extended based on performance ) Work Location : Thane office (Maharashtra) Transport provided : Yes (from Thane station) Working Mode ( Remote / Hybrid ) : Work from office. Shift timings : 9 am to 5.30pm Main Responsibilities: KEY RESPONSIBILITIES 1) To maintain high degree of quality of documents required for submissions to get the approval without deficiency / non-critical deficiency. 2) Timely readiness and sub...

Roles and Responsibilities: - Authorize release of test report based on the Buyers protocol & test methods - On time responds to Buyers & clients queries, emails and calls - Responsible for reviewing revisions, updates on test parameters, protocols and regulations, etc. and circulating these to the concerned lab team - Training lab staff as per updated, revised protocol received from clients and brands - Support team to develop capability on new test parameters as received in buyer protocol - Training & Supervising the handling, operating and maintenance of test equipment. - Supervising preparation and maintenance of document as per requirement of ISO 17025 - Monitor accuracy of ILC/ PT prog...

Roles and Responsibilities: - Authorize release of test report based on the Buyers protocol & test methods - On time responds to Buyers & clients queries, emails and calls - Responsible for reviewing revisions, updates on test parameters, protocols and regulations, etc. and circulating these to the concerned lab team - Training lab staff as per updated, revised protocol received from clients and brands - Support team to develop capability on new test parameters as received in buyer protocol - Training & Supervising the handling, operating and maintenance of test equipment. - Supervising preparation and maintenance of document as per requirement of ISO 17025 - Monitor accuracy of ILC/ PT prog...

As a Health Operations Associate Manager at Accenture, you will play a crucial role in embedding digital transformation in healthcare operations from end-to-end. Your responsibilities will include driving superior outcomes and value realization in the present while ensuring streamlined operations to cater to the evolving healthcare market of the future. Joining the Healthcare Management team, you will oversee the administration of hospitals, outpatient clinics, hospices, and various other healthcare facilities. This encompasses managing day-to-day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality ass...

As a Regulatory Affairs Manager specializing in CMC, you will be responsible for leading and managing all CMC regulatory activities related to USFDA submissions, specifically focusing on ANDA preparation, review, and filing. Your role will involve overseeing the compilation and timely submission of Annual Reports, amendments, and responses to deficiencies. You will collaborate with cross-functional teams such as Quality Assurance, Production, and R&D to gather the necessary documentation and data required for regulatory submissions. A significant aspect of your responsibilities will include reviewing and ensuring compliance of Batch Manufacturing Records (BMR), process validation documents, ...

As a candidate for the position, you should hold a Graduate degree along with a 1-year PGDHA or equivalent qualification. Alternatively, you may have 3 years of experience in CMC. The role involves working in Regular/FHA settings with a salary as per institutional rules. Applicants should be 35 years old or below, and please note that accommodation will not be provided. Preference will be given to candidates who have successfully completed the Jr. Administrative Assistant - 4th year program.,

Lead Analyst- Emerging Markets Strategy: Elevate Your Impact Through Innovation and Learning Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 500 companies. With a presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, artificial intelligence, and unparalleled subject matter expertise to elevate our clients' business impact and strategic decision-making. Our team of over 4, 500 talented professionals operates in countries such as India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets like Colombia,...

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 ...

Role & responsibilities Review and authorize change controls, assessing their impact on regulatory submissions. * Coordinate and organize meetings with cross-functional teams to discuss IRs, DRLs, and CR letters from agencies; circulate Minutes of Meeting (MoM) and follow up on action items. * Compile and coordinate high-quality CMC regulatory submissions for the US market in compliance with current regulatory guidelines and timelines. * Assess change controls from formulation plants and categorize them based on risk to product quality and compliance. * Plan, review, and submit CBE, CBE-30, and Prior Approval Supplements (PAS). * Draft high-quality responses to regulatory agency letters (IR,...