408 Ectd Jobs

We are looking for Sr. Manager / AGM - Regulatory Affairs handling Regulated Market(US, EU, UK, Australia, etc.) in pharma. Details are as below - Responsible for overseeing al aspects of regulatory compliance within a company, ensuring that new drug product drug substance applications and marketed products adhere to all relevant regulations set by regulatory agencies like the MHRA, EMA, TGA ,DIGIMED and other international bodies, by leading a team to manage registration processes, maintain compliance, and strategically navigate complex regulatory landscapes to successfully launch and maintain pharmaceutical products on the market. Developing and implementing comprehensive regulatory strate...

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. 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: With support, advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Lia...

Drug regulatory affairs (DRA) required at panipat for a MNC company Qualification- Any pharma Exp- min 2yrs in DRA salary- upto 45k Location- Panipat Wtsapp me resume at 8295842337- Mr. Bansal Required Candidate profile Prepare & submit regulatory dossiers, manage CTD/eCTD filings, coordinate with DCGI, handle queries & variations, ensure compliance, support audits, and maintain regulatory documentation.

Role & responsibilities Responsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries. Review and submission of Response to queries raised on DMF by USFDA, and other agencies. Review and submission of Amendments and revisions of Drug Master Files. Review and ensuring the regulatory compliance of CMC information and manufacturing facilities of advanced intermediated through regular visits, which are intended to submit to regulatory markets. Evaluation of cost reductions processes in regulatory point of view and submitting to different regulatory agencies. Review of OOS, BPR, process validation, and othe...

Role & responsibilities: To support and manage regulatory submissions, product registrations, and lifecycle maintenance activities in compliance with global regulatory requirements, ensuring timely approvals and sustained market authorization of pharmaceutical and life science products. Key Responsibilities Prepare, review, and submit regulatory dossiers (CTD / eCTD) for regulated and semi-regulated markets Handle product registrations, renewals, variations, and amendments Compile and maintain CTD Modules 15 as per regulatory guidelines Respond to regulatory authority queries, deficiency letters, and commitments within defined timelines Coordinate with QA, QC, R&D, Production, Packaging, and...

Role & responsibilities Handle minimum 2 projects per month (may vary as needed). Act as SPOC for clients for assigned and junior writers projects. Attend client meetings and coordinate with internal teams. Deliver high-quality documents and incorporate feedback. Review and mentor Junior Medical Writers; provide training and guidance. Ensure adherence to all applicable SOPs and participate in trainings. Support Senior Medical Writers in annual SOP updates . Preferred candidate profile Degree in Life Sciences/Pharmacy/Medicine. Relevant 56 years of medical writing experience. Strong communication, quality focus, and project management skills.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Senior Regulatory Affairs Associate Good experience in handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant ...

Company Name: Exemed Pharmaceuticals Designation - IRA Officer/Sr.Officer Location - Vadodara ( Corporate Office) Role & responsibilities Prepare, review, compile and submit regulatory dossiers (CTD/ACTD/Country specific format). Communicate with cross functional team for CMC documents, review and provide feedback to team. Keep up-to-date with changing global regulations. Communicate regulatory updates to internal teams. Maintain updated regulatory files and technical documents till Product life cycle management. Respond to regulator queries received from Internal and External stake holders within timeframe. Review of artworks as per labelling requirement of various countries for regulatory ...

JOB Responsibility Preparation, review & submission of ectd/ctd dossier as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for pharmaceutical products Preparation, review & submission of dossier as per DCGI requirement for submission in CDSCO Preparation, review & submission of techpack as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for Nutraceutical products Query response raised by (MoH/Customer) to EU, Regulated, and Emerging & ROW of Pharma & Nutra products Documents review QQF, Change control, specifications, Commercial specifications, artworks Process Validation Protocols & Report, Hold time study protocol & report, ...

Medblue Innovations Private Limited is looking for Regulatory Specialist to join our dynamic team and embark on a rewarding career journey We are looking for skilled Regulatory Specialists to join our team at Medblue Innovations Private Limited. The ideal candidate will have a strong background in regulatory affairs and be able to ensure compliance with relevant laws and regulations. Roles and Responsibility Develop and implement regulatory strategies to achieve business objectives. Conduct thorough reviews of regulatory documents and submissions. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Provide expert guidance on regulatory matters to intern...

We are looking for Manager- Regulatory Affairs handling Regulated Market (US, EU, UK, Australia, etc.) in pharma. Manage registrations, submissions, GCP/GMP compliance, liaise with authorities and lead the regulatory team. Required Candidate profile Deep understanding of global pharmaceutical regulation, including ICH guideline and relevant regional regulation. Experience in drug development process, from pre-clinical to post-market surveillance. Perks and benefits Personal Accident Policy Mediclaim Policy

Roles and Responsibilities:- Collect and coordinate information and compile regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy. Preparation & compilation of dossier in CTD, ACTD, ECTD & country specific format according to guidelines of countries. Response to query/deficiency/Notice of Deficiency raised by Drug Regulatory Authority or technical representative. Coordination with Quality Control, Quality Assurance and Production department for regulatory documents. Timely compile documents for license renewals, update and re-registrations. Maintain regulatory files/database and chronologies in good order. Establish and ma...

Job Title: Manager II – India Regulatory and business Conitnuity 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.” Key Responsibilities: To evalua...

We are looking for skilled Regulatory Specialists to join our team at Medblue Innovations Private Limited. The ideal candidate will have a strong background in regulatory affairs and be able to ensure compliance with relevant laws and regulations. Roles and Responsibility Develop and implement regulatory strategies to achieve business objectives. Conduct thorough reviews of existing regulations and identify areas for improvement. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Prepare and submit regulatory documents, such as applications and reports. Monitor and analyze changes in regulatory environments that could impact the company. Provide traini...

We are looking for a highly skilled and experienced Regulatory Executive to join our team at Alvita Pharma. The ideal candidate will have a strong background in regulatory affairs and excellent communication skills. Roles and Responsibility Develop and implement regulatory strategies to achieve business objectives. Prepare and review regulatory documents, including applications and reports. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Conduct research and analysis on changing regulatory environments and their impact on the company. Build and maintain relationships with regulatory authorities and other stakeholders. Ensure timely submission of reg...

We are looking for highly skilled Regulatory Specialists to join our team at Medblue Innovations Private Limited. The ideal candidate will have a strong background in regulatory affairs and be able to ensure compliance with relevant laws and regulations. Roles and Responsibility Develop and implement regulatory strategies to achieve business objectives. Conduct thorough analysis of regulatory requirements and provide expert advice. Collaborate with cross-functional teams to ensure compliance with regulatory standards. Prepare and review regulatory documents, such as applications and reports. Stay up-to-date with changes in regulatory requirements and advocate for updates. Provide training an...

QA Team Lead 843 Job Summary We are seeking a highly skilled and experienced Life Sciences Quality Assurance (QA) Team Lead Systems & Tools Management (QMS) to join our Life Sciences Practice. This role involves leading QA teams, managing Quality Management Systems (QMS), and ensuring compliance with global regulatory standards such as GMP, ISO, ICH, cGMP, and GLP . The QA Team Lead will oversee QMS components, documentation control processes, audit readiness, and continuous improvement initiatives. The position requires strong expertise in QA systems, regulatory guidelines, and cross-functional collaboration across manufacturing, regulatory, and quality functions. Key Responsibilities Team ...

Role & responsibilities: Responsible for filings of MA applications for EU and UK market Responsible for preparation of checklist for documents required for initial submission for EU and UK market Responsible for review of new projects documents for EU and UK market Responsible for review of documents like specification, MFC, MPR, Vendor documents and submission related documents Responsible for handling of comments received from Regulatory Authority of EU and UK Co-ordinate with various departments like Formulation and manufacturing plant for filing documentation/ customer query Provide dossier for online audit to concerned customers. Submitting response to due diligence and the proceeding ...

Role & responsibilities 1. Regulatory Submissions and Approvals: Prepare and submit dossiers for product registrations in ROW, Africa, LATAM, CIS, and ASEAN markets, ensuring adherence to country-specific guidelines and requirements. Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for regulatory submissions. Liaise with regulatory authorities and consultants in these regions to facilitate product approvals and resolve any queries or deficiencies. 2. Compliance and Documentation: Ensure compliance with local regulatory requirements, guidelines, and international standards (such as WHO, ICH, or country-specific regulati...

Job Title: Senior Executive / Manager 2 – Plant Regulatory Affairs Business Unit: R&D1 Regulatory Affairs Job Grade G11B/G11A 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: Particip...

About The Role Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and r...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 count...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 count...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 count...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 count...