333 Regulatory Submissions Jobs - Page 10

As a Regulatory Affairs Specialist, you will be responsible for the following tasks: Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil, and ROW market. This includes ensuring compliance with the specific requirements of each regulatory body. Handling the preparation of query responses for drug substances in both highly regulated and less regulated markets, catering to the needs of diverse customers. Creating applicant parts and closed parts for submission to different regulatory authorities on behalf of various clients. Managing the annual updates and amendments of drug ma...

Job Summary: The Team Leader Finance - Reporting will be responsible for end-to-end financial and regulatory reporting related to GIFT City financial books of the life insurance business. This includes timely closure of Gift city books, OPEX booking, GL reconciliation, and ensuring compliance with Statutory regulations. The role involves working closely with cross-functional teams to support business performance reporting, financial control, and regulatory submissions Key Responsibilities: Prepare and file all statutory returns in line with GIFT City regulations. Ensure adherence to deadlines, completeness and compliance in regulatory submissions. Monitor and track operational expenses (OPEX...

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as deliver...

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU. Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

As an intern at Noccarc Robotics, your day-to-day responsibilities will involve conducting clinical validation tests of ICU ventilators, patient monitors, and other critical care devices in hospital and laboratory settings. You will collaborate with intensivists, respiratory therapists, and ICU staff to assess product performance. Additionally, you will be responsible for designing and executing ex-vivo and in-clinic testing protocols to validate device functionality, accuracy, and safety. Your role will also include collecting, analyzing, and interpreting clinical data to provide insights for product improvements. You will document findings, prepare validation reports, and contribute to reg...

Specialized expertise in Inhaler Products including Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI). Method development, validation, and forced degradation studies specific to inhalation dosage forms. Execution and support of technology transfer for analytical methods related to MDI/DPI. Ensure compliance with Quality Assurance systems and applicable regulatory guidelines (ICH, FDA, EMA). Lead analytical activities for ANDA and NDA projects for respiratory products. Coordinate with cross-functional teams for project planning, documentation , and timely regulatory submissions. Review and preparation of analytical method validation protocols, reports, and supporting documentation for...

Hiring for RA Executive / AM For Pharmaceutical-Formulation Qualification: Bsc/B.PHARMA Experience: 7 to 15 Years CTC: 10.0 LPA Send CV on sdpbharuch@gmail.com sub With : RA Vadodara Free Job Share with your Friends & Colleagues!! Required Candidate profile Join Our WhatsApp Group: https://chat.whatsapp.com/EMLcH2RoVs1AzcbRKmZkjZ Follow Our WhatsApp Channel: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y

About Zydus Wellness Zydus Wellness, an FMCG leader, develops, manufactures, and markets health and wellness products, integrating healthcare, skincare, and nutrition. Founded in 1988 with Sugar Free, India’s first zero-calorie sugar replacement, it now manages seven global brands, including Complan, Glucon-D, Everyuth, and Nutralite. The company serves over 50 million families and supports more than 90,000 dairy farmers and 2,000 MSMEs. With a focus on research, quality, and innovation, Zydus Wellness operates on core pillars of manufacturing integrity and supply chain efficiency. Headquartered in Ahmedabad and Mumbai, it runs four manufacturing facilities across India and eight co-packing ...

Job Summary: The Regulatory Affairs Manager will oversee all regulatory compliance activities related to the companys nutraceutical products, ensuring that all the marketing practices meet applicable global standards (e.g., FDA (U.S.), EFSA (EU), FSSAI (India) . Key Responsibilities: Regulatory Strategy & Compliance. Develop and implement regulatory strategies for product launches and market expansions. Ensure the certifications are renewed on time and also apply for new certifications in new geographies. Interpret and apply country-specific regulations (FDA/DSHEA, EFSA, FSSAI, etc.) to ensure compliance. Dossier & Documentation Management. Prepare and maintain regulatory submissions, includ...

As a Clinical Data Manager at Clinvigilant Research Pvt. Ltd., a company of GSC Group, located onsite in Ahmedabad, you will play a crucial role in managing and overseeing the data collected during clinical trials. With 3 to 6 years of experience in clinical data management or a related field, you will ensure the accuracy, integrity, and compliance of clinical trial data with regulations. Your primary responsibility will be to oversee the collection, management, and quality control of clinical trial data. Working closely with clinical research teams, statisticians, and regulatory authorities, you will ensure that data is accurately recorded, processed, and analyzed for clinical trials. Your ...

As the DM- Regulatory Affairs at Olympus Medical Systems India Private Limited, your primary responsibility will be to oversee Indian regulatory affairs activities related to Gastrointestinal (GI) & Olympus products. You will also be responsible for advising and consulting with stakeholders about compliance with CDSCO, BIS, WPC, and other applicable regulatory bodies. Your role will involve implementing best practices and contributing to both the strategic and operational functions of the regulatory affairs team. Your key responsibilities will include assessing regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. You will evaluate the reg...

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into pro...

As the Statistical Science Director at our organization, you will play a crucial leadership role in advancing the application of statistical science within the pharmaceutical industry. Your extensive experience in statistical methodology, project design, delivery, and interpretation will be instrumental in guiding various stages of product development. Your responsibilities will include leading statistical strategy for projects, contributing to regulatory submissions, and influencing internal governance decisions. The ideal candidate for this role is recognized externally as an expert in statistical methods and possesses the ability to guide complex analyses while mentoring junior staff. Str...

Your main responsibilities as a selected intern will include: Conducting clinical validation tests of ICU ventilators, patient monitors, and other critical care devices in both hospital and laboratory settings. You will collaborate closely with intensivists, respiratory therapists, and ICU staff to evaluate the performance of products. Additionally, you will be responsible for designing and implementing ex-vivo and in-clinic testing protocols to ensure the functionality, accuracy, and safety of devices. You will play a key role in collecting, analyzing, and interpreting clinical data to generate valuable insights for enhancing product improvements. Documenting your findings, preparing valida...

As a Polymorph Screening Scientist at Morepen Proprietary Drug Research Pvt Ltd. (MPDRPL), your primary responsibility will be to lead the screening and selection of solid forms for drug candidates. You will play a crucial role in improving the physicochemical properties of active pharmaceutical ingredients (APIs) by overseeing polymorph screening activities. It is essential to identify the most stable and bioavailable forms of drug substances for regulatory submissions. Collaborating with cross-functional teams, you will mentor junior scientists and drive advancements in solid-state drug discovery. Your key responsibilities will include overseeing the screening of potential polymorphs, solv...

The Manager - Nasal Spray Formulation Development will lead the development of innovative nasal spray formulations, driving projects from concept to commercial scale-up. You will focus on the design, development, and optimization of nasal spray drug products, ensuring regulatory compliance and meeting quality standards. Leading a team of formulation scientists, you will collaborate with cross-functional teams to deliver high-quality, cost-effective nasal spray formulations for global markets. Key responsibilities include having relevant experience in developing and technology transferring Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and...

Job description OBJECTIVE: To maintain optimum quality in Formulation research and generation of quality data in Formulation Development department to support the development of a safe and quality product. RESPONSIBILITY : Formulation development of oral solid, Liquid, Parenteral and semisolid products by QbD Approach for Regulatory & ROW markets. Technical assessments of projects (Screening of Project, pipeline) Scientific literature Search and patents evaluation for strategic development. Technical screening of API, RM, PM sourcing for F&D activity. Formulation Development Strategy preparation with design around opportunities & developing Bio-equivalent products. Provides support and guida...

Role & responsibilities : Extend support on the compiling, submission and approval of Country Specific Submissions files for the responsible countries (NDA, LCM & post approval changes) Participate and extend support during initial submission planning Review & update the list of documents required for the submission (e.g., NDA, variation, tenders) Manage compilation and preparation of regulatory documents, information, data technical files to support approvals for new product registration, renewals and changes Preferred candidate profile :

Review, compile and Preparation of original drug master file (DMF)/ ASMF as per GUDFA guidance/EMA guidance in eCTD format for various agencies. Review, compile and Preparation of Response to Deficiency as received from Agency. Working on Life Cycle management of DMF including amendment, biannual update, Annual Reports etc. for various markets. Preparation of Applicants Part and sharing with Customers and resolving customers query. Sound knowledge about ICH guidelines GDUFA and EMA guidelines

Job Description OBJECTIVE: To maintain optimum quality in Formulation research and generation of quality data in Formulation Development department to support the development of a safe and quality product. RESPONSIBILITY : Formulation development of oral solid, Liquid, Parenteral and semisolid products by QbD Approach for Regulatory & ROW markets. To handle a team of 10 to 15 team members. Technical assessments of projects (Screening of Project, pipeline) Scientific literature Search and patents evaluation for strategic development. Technical screening of API, RM, PM sourcing for F&D activity. Formulation Development Strategy preparation with design around opportunities & developing Bio-equi...

Role & responsibilities Regulatory Affairs Associate Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established CLIENTprocedures and regulatory requirements Planning, preparing and executing simple submissions, an...

RESPONSIBILITIES Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU, UK and AUS-NZ. Publishing in eCTD format and submission to respective Regulatory Agencies. Compilation and submission of variation applications for EU, UK and AUS-NZ. Review of documents related to compilation of dossiers and query responses. Up to date knowledge of regulatory guidelines and requirements. DESIRED SKILLS Must have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycle Should have handled initial MAA submission & Variations for EU. Good technical knowledge, review skills and understanding of regulatory submissions Strong know...

RESPONSIBILITIES Coordination with the customer to compile the dossier as per current registration regulations in SEA & East Africa markets. Coordination with the customer at various registration stages to obtain approval. Analyze the molecule and determination for need of Bioequivalence or bio waiver studies. Life cycle management of product license by filing renewals and analyzing the type of variation needed to be based on the proposed changes to DMF, formulation, packaging, or excipients. Review and approve the artworks as per Brazil and Canada market regulations. Interpretate deficiencies received compile and submission responses within the stipulated time frame. Maintenance of tracker ...

Role Description It is crucial for the bank to understand how profitable each businesses activity is and Finance has a responsibility to understand precisely the resource commitment the bank makes to any given client or transaction e.g. cost, capital, funding, liquidity and risk. Finance is playing a central role in keeping the bank focused on simplification and financial resource management. Liquidity Data Measurement and Reporting (LDMR) Analysis and Design is an integral part of the banks liquidity reporting framework responsible for regulatory interpretation of liquidity legislation and requirements, analysis and control. Liquidity Data Measurement Analyst is essential for ensuring the d...

Proficient in preparing & submitting regulatory fillings for product approvals, conducting clinical evaluations, managing risk assessments, ensuring post market compliance. Experienced in EU MDR 2017/745, US FDA, Indian MDR 2017 & ISO 13485 Standards Required Candidate profile Candidate from Medical Device company will be preferred. Deeply knowledge of EU MDR 2017/745, CE Marking, US FDA, Indian MDR 2017, ISO 14971 and Risk Management is mandatory for this position.