162 Dossier Jobs - Page 2

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or ...

Role Name: Manager International Regulatory Lead (IRL) Department Name: International Regulatory Team, Global Regulatory Affairs Role GCF: 5A ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to -optimize product development and regulatory approvals in International countries -develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities -Advises Global teams on regulatory impl...

Greetings of the day ! Our reputed MNC Client is hiring for: Designation: Regulatory Affairs- EU Market- Pre & Post Approval Location: Hyderabad Shift: General Work Mode: WFO (5 days working) Interview Mode: F2F interview NOTE: Looking for candidates from Generic Pharma and not from API as this is for formulation Role & responsibilities: 1. Component with EU-Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module 2. Well versed with EU- Regulatory guidance and Processes (i.e. Ability to understand and interpret technical expectations as per applicable ICH & EMEA guidelines) 3. Clear Knowledge of basic aspect...

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.

Role & responsibilities Prepare CTD dossiers for regulated markets and other markets as per country specific guidelines. Attend to various queries raised by the importing countries wrt to Co.products & dossiers. Coordinate with factory.Role & responsibilities Preferred candidate profile 1-3 Years Experience In Regulatory Affairs for formulations. Excellent communication skills both written and verbal.

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...

Responsibilities: * Lead regulatory strategy development & implementation * Manage dossier preparation, compilation & submissions * Oversee drug regulatory affairs in Row & Emerging markets

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...

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...

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...

Responsibilities: * Lead regulatory strategy development & implementation * Manage dossier preparation, compilation & submissions * Oversee drug regulatory affairs in Row & Emerging markets

Our Client a reputed Pharma company - Post : Deputy Medical Manager Services & PVOI Gender : Female Location : Lower Parel, Mumbai Experience : Min 2 years in Medico Marketing within the Pharmaceutical Industry Qualification : M. Pharm (Pharmacolgy) / D. Pharma Job Profile Provide scientific support to brands by delivering the latest scientific information on products, therapy areas, and clinical guidelines Develop and ensure the quality of scientific materials, including Product Monographs, LBLs, VAs, PSIs, PIs, and PLIs Conduct medical training sessions and product training for field personnel Contribute to new product ideation, including indication expansion, unique dosage forms, and nove...

End-to-end management of regulatory submissions for finished dosage forms. Prepare & compile high-quality dossiers (Modules 1–5). Coordinate cross-functional teams, handle queries, ensure compliance, and support lifecycle mgmt of products.

Dear All, We are looking for a Regulatory Affairs Assistant Manager/Deputy Manager with 7-10 years of experience in pharmaceutical formulations, specifically for the Europe market . Key Responsibilities: Prepare, compile, and submit high-quality regulatory dossiers in compliance with EU and UK market requirements. Collaborate with cross-functional teams (CFTs) to ensure alignment with regulatory standards and timely compliance Maintain accurate and up-to-date regulatory documentation and manage regulatory databases effectively. Demonstrate strong communication skills to engage with internal teams and external regulatory authorities. Possess in-depth knowledge of EU regulatory guidance, proce...

Role & responsibilities Prepare, compile, and assist in submission of regulatory applications/dossiers for medical devices and IVDs under MDR 2017. Support licensing/registration processes (Forms MD-5, MD-14, MD-15, MD-16, MD-24 etc.) for multiple products and clients. Liaise with CDSCO, State Licensing Authorities, and notified bodies during submission and approval processes. Track and manage multiple regulatory projects simultaneously, ensuring adherence to timelines. Maintain regulatory documentation, trackers, and compliance records for all client projects. Coordinate with SRSS internal teams and client stakeholders to collect required technical and compliance documentation. Monitor regu...

Greetings!!!! We are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre. Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes. Key Responsibilities: Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved and Tentative) submissions. Responsible for filing supplements : CBE, CBE-30, PAS, Controlled Correspondence, Annual Reports/Updates. Planning, reviewing, and timely submission of assigned projects in compliance with FDA guidelines . Strong interpretation of FDA queries and drafting of high-quality responses. Review and preparati...

Dear All, We have arranged a Walk-In Interview for Regulatory Affairs (Formulations) - Executive / Sr. Executive where we are seeking a proactive and detail-oriented Regulatory Affairs professional to join our dynamic team! Role & responsibilities Preparation of CTD dossiers for Regulated manket [EU/UK/TGA] or ROW market - Asia & Africa market. Co-ordination with Plant, R&D & ADL to collect inputs required for Regulatory submission. Variation filling. Timely achievement of monthly plan. Interpretation and timely query response. Education - B.Pharm / M. Pharm Desired Skills Knowledge of CTD dossier preparation (EU/UK/TGA) or Asia / Africa. Experience in variation filing & regulatory submissio...

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a Trusted Emerging Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top managem...

Job Responsibilities: Overall Responsibilities: 1. Compiling all the relevant information necessary to prepare best regulatory dossier (M1 to M5) for registration of a new vaccine or a license update in all concerned row countries including WHO Prequalification. 2. Developing and maintaining the Regulatory Dossier Module 1 to Module 5 keeping the document updated throughout the life of the project/product. Ensuring the coordination with the different areas concerned: Clinical Development, Product Development, Marketing and CMC related functions. 3. Participating and performing change control assessment (CCRs) of any necessary changes and implementation plan with a global view for the impacte...

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a Trusted Emerging Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top managem...

- Looking for RA Deputy Manager - for US Market and RA - Asst. Manager - for ROW Market - Only from Pharmceutical Industry

Executive Regulatory Affairs (Europe Market) – Ahmedabad | M.Sc./B.Tech | 3–5 yrs exp. | Prepare & review eCTD dossiers, manage DMFs, submissions, change controls, ensure EMA/USFDA/ICH compliance, coordinate cross-teams, expertise in eCTD software.

Job Title: Regulatory In-charge (Semi-Regulated Markets) Company: GenAide Pharmaceutical Pvt Ltd Location: 909, Satyamev Eminence, Science City Road, Near Shukan Mall, Sola, Ahmedabad, Gujarat 380060 About GenAide Pharmaceutical Pvt Ltd: GenAide Pharmaceutical Pvt Ltd is a young, energetic, and rapidly growing pharmaceutical company committed to delivering high-quality healthcare products. We foster a dynamic work environment with a strong emphasis on teamwork and innovation. Join our already developed team and contribute to our exciting journey! Experience: 5 - 6 years in Regulatory Affairs, with a strong focus on semi-regulated markets. Job Summary: GenAide Pharmaceutical Pvt Ltd is seekin...

The role is to assist in providing the regulatory administration activities of regional regulatory function. This position is responsible for organizing, revising and maintaining all regulatory documents within the regulatory department. The individual will assist in the registration of products by preparing and submitting documentation needed for registration in India. The individual will assist the team in any other responsibility as desired for regulatory work. Education: Postgraduate in Master of Business Administration (Pharmaceutical Management) Graduate in Pharmacy Experience: 4-5 years experience in FMCG/Pharma Industry in the field of pharmaceutical, general category products