3208 Regulatory Affairs Jobs - Page 34

Role Overview: Zeon Lifesciences Ltd is looking for Pharmacy Apprentices to join their team in Noida. As a Regulatory Affairs Apprentice or PMT Apprentice, you will be a part of a premier multi-client Nutraceuticals Products manufacturer in India. Zeon is known for being a research-oriented reliable partner to various health & wellness organizations, formulating and manufacturing Nutraceutical and Ayurvedic products for reputed companies like Danone, GSK, Herbalife, and more. Key Responsibilities: - Regulatory Affairs Apprentice (Male) - Qualification required: B.Tech in Food Technology or MSc in Food Science - Responsible for handling regulatory affairs related to product manufacturing and ...

Role Overview: Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to customers across geographies. The company is organized into two segments - Specialty Pharmaceuticals and Generics & APIs. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma, with Research & Development units in Noida and Mysore, and manufacturing facilities in Mysore, Karnataka and Roorkee, Uttarakhand. Key Responsibilities: - The manufacturing location at Mysore focuses on APIs in Lifestyle driven Therapeutic Areas (CVS, CNS) with a portfolio of complex and newly approved molecules. - The manufacturing location at Roorkee is a state-of-t...

Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives : Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department. 1. Dossier Preparation and Review Oversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with regulatory requirements. Review dossiers prepared by team members to ensure they meet national and international standards. Provide guidance and technical expertise to the team during dossier preparation. 2. Regulatory Submissions and Approvals Manage applications for licenses, permissions, and other regulatory approvals in the country o...

Calibration Med Dev Validation QMS Implementation ProductVerification Medical Devices Iso 13485 Regulatory Affairs PMCF Periodic Safety Update Report EUMDR I MDR CE Marking CER QMS USFDA Required Candidate profile Handle all the documents & control related to the quality. Implementation, Audit, Training & Assessment of Hygiene & Safety. ISO 9001, ISO -13485,

JD To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all CIS Countries and other country as per company requirements. Responsible for final review of dossier before submission To coordinate with technical team for documents required for dossier. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; Provide responses to regulatory agencies regarding product information or issues. Impl...

We are looking for a skilled HSE Officer to join our team in the international sector. The ideal candidate will have 3-7 years of experience in the field. Roles and Responsibility Develop and implement effective health, safety, and environmental management systems. Conduct regular audits and inspections to ensure compliance with regulatory requirements. Provide training and guidance on health, safety, and environmental procedures. Investigate incidents and accidents to identify root causes and implement preventive measures. Collaborate with other departments to develop and implement emergency response plans. Maintain accurate records of health, safety, and environmental performance metrics. ...

Heres how youll contribute: Writing skills, specifically around describing a scene and driving logic Fluent in English language, familiarity with road signs in the US (Other regions including EU is a bonus) AV labeling experience (bounding boxes, etc) College Educated

Provides support according to the needs for delivery activities, i.e. co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. Assist in monitoring the safety profile of products including with activities such as literature review, medical review/evaluation of individual cases or signal detection. Perform literature review -Provide support for the preparation of ad hoc Health Authority queries for TAs, also in particular for short term notice requests. Perform follow up activities on Health Authority Assessment Reports. Assist in providing safety input to Regulatory Affairs and clinical documents. ...

Support group reporting team in loading data onto HFM from onestream. Clearing validations at HFM / OS Preparation of control sheet OS to HFM walk on monthly basis Assistance during H1 / Annual group audit / FC1 and budget submission Migration of onestream to SAP etc. Requirements: Candidate must be pursuing CA course and eligible for industrial training as per ICAI internship guidelines Good exposure in accounting, taxation, financial analysis, and statutory audits during articleship period Strong understanding of IND-AS, Companies Act, and other relevant accounting standards Advanced proficiency in MS Excel (including financial modeling, pivot tables, VLOOKUP)

Your Role Take overall responsibility and project manage the implementation of travel products for clients. Document and track projects using client-specific processes and tools. Act as the single point of contact for the project team throughout the implementation process. Ensure adherence to the client-defined onboarding process, from pre-assessment to post-implementation. Lead local Joint Planning meetings and ensure effective collaboration. Clarify and communicate roles and responsibilities to all project members. Lead weekly conference calls, prepare agendas, and produce detailed call notes. Monitor project progress, ensure timely completion of tasks, and update project tracking tools (e...

Advising potential students on education opportunities in the UK, Australia, Germany, USA, Sweden,France,Italy, Canada, Malaysia, New Zealand, Singapore, Switzerland, Dubai and Ireland. Maintaining accurate ledger Required Candidate profile Educational Counselors provide professional guidance and counselling service to aspirants interested in overseas higher education. Excellent communication skill. Experience in counselling, guidance

Key Responsibilities: Preparation of regulatory dossiers in eCTD format for Europe (hands-on experience in eCTD is a must). Thorough understanding and working knowledge of EU regulatory procedures including DCP (Decentralized Procedure) and MRP (Mutual Recognition Procedure). Compilation and submission of regulatory dossiers for ROW (Rest of the World) markets . Coordination and preparation of responses to deficiencies/queries received from Regulatory Agencies. Application of ICH and EU regulatory guidelines during dossier preparation and submission. Preparation and submission of variation packages for approved products in compliance with applicable regulations. Desired Profile: Bachelors/Ma...

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...

Role & responsibilities Preparation of CTD/ACTD & Country specific Dossiers Handling queries obtained from different regulatory agencies and customers across the world. Compilation, preparation and review of Technical Package of APIs. Compliance to audits of regulatory bodies especially USFDA and EU. Generation of documents from, Production, QC and QA of newly developed products Responsible for record keeping and to ensure correctness of records pertaining to department. • Knowledge of ICH Guidelines to prepare documents accordingly Lead, coordinate, write, critically review and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary document...

Job Title: Manager 2 – MSTG Non Orals Business Unit: R&D1 Regulatory Affairs Job Grade G11A Location : Baroda 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.” Job Description: Process Development and Optimization Su...

Career Category Regulatory Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases, and make people s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what s known today. ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products....

Job Title: Senior Manager – MSTG Non Orals Business Unit: R&D1 Regulatory Affairs Job Grade G9B/A Location : Halol 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.” Job Description: Responsible for the MSTG-NOSD acti...

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...

You will be working for Jubilant Pharma Limited, a global integrated pharmaceutical company that offers a diverse range of products and services to customers worldwide. The company is organized into two main segments: - **Specialty Pharmaceuticals:** This segment includes Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. - **Jubilant Generics (JGL):** JGL is a wholly-owned subsidiary of Jubilant Pharma with Research & Development units in Noida and Mysore, India. JGL operates two manufacturing facilities in Mysor...

Preparation & compilation of Dossiers Knowledge of UK & EU Market, CTD Review of Artwork. Registration of renewal of products Solve Queries & Timely compile materials for license renewals, updates and registration Review changes to existing products Education PG: M.Pharma in Pharmacy

Role Overview: As a Regulatory Compliance Manager at CareNX, located in Mumbai, you will play a crucial role in ensuring the company's adherence to regulatory requirements and standards. Your responsibilities will include monitoring and analyzing regulatory changes, managing regulatory affairs, and ensuring compliance in all operational activities. You will collaborate closely with the finance team to guarantee regulatory compliance in financial practices. Key Responsibilities: - Monitor and analyze regulatory changes relevant to the healthcare industry - Manage regulatory affairs to ensure adherence to standards like ISO13485, IEC, CDSCO, CE, and FDA - Ensure compliance in all operational a...

As a Junior Product Specialist at our company, you will play a crucial role in supporting our medical devices portfolio. Your responsibilities will include: - Assisting in product demonstrations, training sessions, and post-sale support for healthcare professionals. - Providing clinical and technical support during product trials or installations. - Coordinating with sales and marketing teams to execute product strategies. - Maintaining up-to-date product knowledge and sharing feedback with internal stakeholders. - Conducting competitor and market analysis to identify trends and opportunities. - Preparing product documentation, brochures, and training materials. - Supporting the Product Mana...

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 Overview: You will be joining Absolute as a Regulatory Affairs Executive, where you will play a crucial role in ensuring compliance with regulatory standards and guidelines in the nutraceutical and supplement industry. Your responsibilities will include managing FSSAI compliance and licensing, reviewing formulations for compliance, maintaining SOIs, handling documentation and record-keeping, coordinating regulatory submissions and approvals, liaising with cross-functional teams, staying updated on regulatory intelligence, and ensuring other statutory compliances. Key Responsibilities: - Manage Central/State FSSAI license applications, renewals, and modifications - Review formulations an...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP HCM Payroll Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving activit...