454 Regulatory Submissions Jobs - Page 4

Dear Candidate, We are hiring for the Regulatory Affairs role-handling the below job responsibilities, Job Title: Regulatory Affairs Manager Company: Brinton Pharmaceuticals Ltd. Location: Kharadi, Pune Salary: Best in Industry Joining: Immediately Job Description: Regulatory Affairs Manager Position Overview: We are seeking an experienced and resourceful Regulatory Affairs Manager to lead efforts focused specifically on product approvals, price compliance, and regulatory risk mitigation in support of sales, pricing, and marketing. Key responsibilities include obtaining necessary approvals, ensuring price compliance, reviewing promotional materials, and addressing regulatory risks in domesti...

You will be a part of the DCM team, assisting Sr. Product Specialist/Product Specialist DCM in all aspects of DCM origination, Distribution and execution of debt issuances for a cross-section of issuers across corporates, NBFCs, financial institutions, etc. **Key Responsibilities:** - Support Product Specialist/Sr. Product specialist on transactions by delivering operational, executional and documentation related assistance - Ensure seamless transaction delivery, client servicing, and post-deal management of the client/transaction - Keep track of market trades/primary transactions to apprise the team on market trends and provide intelligence for mandates - Provide inputs to senior team membe...

Job Description Role Summary Lead end-to-end operational delivery of country specific data generation activities Local Data Generation (LDG), Investigator Studies Program (ISP), post-approval research, and other in-scope interventional/non-interventional studies. Serve as the country study operations manager, accountable for project planning, execution, vendor oversight, budget management, compliance, and timely delivery of study milestones. Train local field medical/study leads on subjects related to study operations and corresponding SOPs. Primary Responsibilities LDG In collaboration with the study lead, who is overall accountable for the study, coordinates the end-to-end process for exec...

Roles and Responsibilities Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities. Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc. Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format. Preparation of query response for submitted applications received from various regulatory authorities. Responsible for review of change controls and checking for regulatory compliance for all documents. Exposure of Dossier c...

As a Packaging Development Manager at Amneal, you will be responsible for developing and implementing packaging strategies for new and existing products. Your key responsibilities will include: - Selecting and validating packaging materials in accordance with regulatory and stability requirements. - Coordinating with vendors for sourcing, trials, and cost negotiations. - Conducting packaging line trials and ensuring compatibility with filling equipment. - Preparing and reviewing packaging specifications, SOPs, and technical documentation. - Ensuring compliance with cGMP, USFDA, EU, and other global regulatory norms. - Driving packaging innovation for sustainability and cost optimization. - C...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description The API EM TS/MS person-in-plant (PIP) mfg. scientist provides leadership and functional-area expertise at the designated C...

Let's do this. Let's change the world. In this vital role you will act as the Quality Engineering representative on multi-functional teams, employ quality principles and company's procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development and lifecycle management of final product align with dynamic global regulations and standards. The Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercialization. In addition, this role will also ...

Job Description Route Design & Development: Develop novel and non-infringing synthetic routes for APIs and key intermediates. Evaluate literature and patent landscape for synthetic feasibility and freedom to operate. Process Optimization Conduct lab-scale synthesis and optimize reaction conditions for yield, purity, and scalability. Support process development and scale-up activities from lab to kilo-lab and plant level. Analytical & Regulatory Support Coordinate with Analytical R&D for impurity profiling and characterization of intermediates. Support preparation of technical data for DMF, ANDA, and regulatory submissions. ?Technology Transfer He will prepare process development report and t...

As an Experienced Medical Writer at NovoBliss Research Private Limited, your role involves producing scientific documents, managing medical communications, and conducting thorough research. Your daily tasks will include writing, editing, and ensuring the accuracy of clinical study reports, research articles, regulatory submissions, and marketing materials. Collaboration with cross-functional teams is essential to gather necessary information and meet project deadlines. Key Responsibilities: - Produce scientific documents - Manage medical communications - Conduct thorough research - Write, edit, and ensure accuracy of clinical study reports, research articles, regulatory submissions, and mark...

Umedica Laboratories is seeking an experienced and dynamic Sr. Manager for USA Regulatory Affairs to join our global regulatory team. This is a pivotal role responsible for leading regulatory strategies, submissions, and compliance activities for pharmaceutical products in the US market. Key Responsibilities: Lead regulatory submissions and maintenance activities to US FDA standards. Develop and implement regulatory strategies aligned with business goals. Manage communication and negotiations with regulatory authorities. Collaborate cross-functionally with clinical, quality, and manufacturing teams. Ensure compliance with all applicable FDA regulations, guidelines, and internal SOPs. Support...

As the Clinical Trials Coordinator, you will be responsible for overseeing the clinical trials start-up process, from the receipt of protocols through the Scientific Review Committee and IRB submissions, as well as site activation activities. Your duties will include data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries. Key Responsibilities: - Prepare and/or complete regulatory-related reports and IRB submissions. - Maintain and organize study regulatory binders, entering all required study data on an ongoing basis. - Ensure all study-related sam...

You are currently seeking a full-time office-based Experienced Study Start-up Submissions Coordinator to join the Clinical Operations team in Mumbai, India. As a vital part of the team, your role will involve accomplishing tasks and projects crucial to the company's success. If you are looking for an exciting career opportunity to utilize your expertise and further develop and grow your career, this is the perfect opportunity for you. Responsibilities: - Perform activities within the country leading to the activation of investigative sites in all phases of clinical trials. - Prepare, review, and submit documents to Regulatory Agencies. - Communicate with global study teams and personnel rega...

Role Overview: You will be responsible for developing and reviewing study protocols and informed consent documents. Monitoring clinical trial progress and ensuring adherence to GCP, FDA, and IRB regulations will be a key part of your role. You will also be involved in collecting, managing, and analyzing clinical data, preparing regulatory submissions and study reports, as well as collaborating with cross-functional teams including investigators and coordinators. Key Responsibilities: - Develop and review study protocols and informed consent documents - Monitor clinical trial progress and ensure adherence to GCP, FDA, and IRB regulations - Collect, manage, and analyze clinical data - Prepare ...

Roles & Responsibilities Regulatory Submissions & Filings Prepare, review, and submit DMFs, CEPs, and regulatory dossiers for API registration in global markets (USFDA, EMA, WHO, etc.). Ensure submissions are complete, accurate, and in CTD/eCTD format. Coordinate with internal teams to gather technical and manufacturing data for filings. Track submissions, approvals, and queries from regulatory authorities and ensure timely responses. Dossier Preparation & Maintenance Prepare and maintain dossiers in compliance with current regulatory standards and GMP requirements. Update existing dossiers to reflect process or analytical changes. Review and compile CMC (Chemistry, Manufacturing & Controls)...

Job Description We are looking for an experienced Regulatory Affairs Manager to manage and oversee regulatory submissions and compliance for Emerging or ROW (Rest of the World) markets . The role requires in-depth knowledge of international registration requirements, dossier preparation, and life-cycle management of pharmaceutical products. Key Responsibilities Manage regulatory submissions, approvals, and renewals for Emerging & ROW markets (Asia, Africa, Latin America, CIS, Middle East, etc.). Prepare, review, and compile CTD / ACTD dossiers for new product registrations. Coordinate with R&D, QA, QC, and Production teams to gather technical data and ensure dossier readiness. Maintain and u...

As an R&D Senior Manager at Vedic, you will play a crucial role in leading the formulation development process for cosmeceutical products. Your responsibilities will include: - Leading the formulation development process by incorporating Vedic principles and natural ingredients into products - Collaborating with cross-functional teams to create effective, safe, and aesthetically pleasing formulations - Overseeing the production scale-up of formulated products and ensuring a seamless transition from lab-scale to commercial production - Collaborating with manufacturing teams to optimize production processes and troubleshoot any issues - Overseeing stability studies to assess the shelf-life, ef...

As a Regulatory Affairs Manager for biologic products, your responsibilities will include: - Developing global regulatory strategies for biologic products throughout all development phases in the US, EU, and rest of the world, ensuring alignment with business objectives and regulatory requirements in different regions (FDA, EMA, emerging markets). - Preparing, reviewing, and managing high-quality regulatory submissions such as INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, and post-approval changes (variations, amendments). - Engaging with global regulatory agencies to support product approvals and address inquiries, collaborating with R&D, Quality, Clinical, and national regulatory teams t...

Site Name: UK London New Oxford Street, Bengaluru Luxor North Tower, Egypt - Cairo, Poznan Grunwaldzka, USA - North Carolina - Durham, Warsaw Posted Date: Oct 27 2025 Are you a driven and innovative Regulatory Affairs professional looking to make a meaningful impact on the global supply of medicines Join our Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Group within Global Regulatory Affairs at GSK, where we play an essential role in ensuring uninterrupted access to life-changing medicines for patients worldwide. As part of the CMC Regulatory Affairs team, you'll collaborate across Global Supply Chain (GSC), Technical, Quality, and Local Operating Companies to support lifecy...

Position Details: Designation: Assistant Manager Regulatory Affairs CMC Location: Navi Mumbai Reporting to: Deputy General Manager Job Summary: The Assistant Manager Regulatory Affairs will be responsible for managing and coordinating regulatory submissions for the US, EU, and Canadian markets, ensuring compliance with applicable regulations (FDA, EMA, Health Canada). The role involves preparing, reviewing, and submitting high-quality regulatory dossiers (NDA, ANDA, MAA, ANDS, etc.) and maintaining effective communication with health authorities/Regulatory Counterparts. Overall Job Responsibilities: 1. Regulatory Submissions Prepare, review, and submit high-quality regulatory dossiers (eCTD ...

About Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the Netherlands to further our mission of saving lives and improving patient care. Job Summary: We are seeking a dedicated and knowledgeable Regulatory Specialist to ensure our medical devices meet local and international regulatory standards. The ideal candidate will have extensive knowledge of CDSCO, ISO, FDA, and other regulatory require...

Roles & Responsibilities: Regulatory Strategy and Leadership 1. Lead the development and execution of global regulatory strategies for formulation-based pharmaceutical products, focusing on EU and ROW markets. 2. Provide strategic direction and leadership to the regulatory affairs team, fostering a culture of excellence and compliance. 3. Stay abreast of evolving regulatory landscapes, guidelines, and requirements in various international markets. 4. Represent the company in interactions with health authorities and regulatory agencies, building strong relationships and advocating for the company's interests. 5. Oversee the preparation and review of regulatory documents, ensuring accuracy, co...

Seeking a Regulatory Affairs professional (5–12 yrs exp, US FDA focus) to manage product approvals, ensure compliance, and liaise with regulatory bodies. B.Pharm/M.Pharm required.

Key Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory submissions including INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, as applicable. 4. Post-approval changes (variations, amendments). 5. Liaise with global regulatory agencies to facilitate product approvals and resolve queries. 6. Collaborate with R&D, Quality, Clinical, and national regulatory teams to ensure regulatory compliance acr...

As a member of Team Amex at American Express, you will play a crucial role in various areas of Regulatory, Communication, Technology, Project/Program Management, Stakeholder Management, Technology Risk, Status Reporting, People Management, and Education and Knowledge. Your contributions will help shape the future of American Express and make a significant impact on the organization. **Key Responsibilities:** - **Regulatory:** - Responsible for Regulatory Submissions like Quarterly RBI KRI submission. - Handling Response to Regulatory Questionnaires/Circulars/Advisories. - Providing regulatory guidance and training on circulars, advisories, Master Directions, etc. - Manage internal audits, 2n...

As an Associate Statistician at YouV, you will be part of a team that believes in alternative thinking and smart work to create human-centric processes focusing on teamwork and co-execution. **Key Responsibilities:** - Assist in conducting statistical analysis for clinical trials. - Perform data cleaning and validation. - Generate summary tables, figures, and listings. - Assist in the development of statistical analysis plans and study protocols. - Collaborate with cross-functional teams to ensure data quality and integrity. - Contribute to the interpretation of study results. - Stay updated with relevant regulations and industry best practices. **Qualifications Required:** - Education level...