333 Regulatory Submissions Jobs - Page 8

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

As a Research Analyst/Technical Writer at MetaMorph, you will play a crucial role in surveying the scientific and intellectual landscape of wearables globally. Your responsibilities will include creating highly detailed and accurate internal and external documentation for internal teams, vendors, and legal teams. It is essential that your work aligns with the latest industry trends and developments in consumer and medical electronics, showcasing your expertise in smart wearable technologies. You will collaborate closely with engineers, researchers, scientists, product managers, and other stakeholders to ensure the accuracy and comprehensiveness of technical documents such as specification do...

As a Clinical Research Associate, your responsibilities will include developing and reviewing study protocols and informed consent documents, monitoring clinical trial progress to ensure adherence to GCP, FDA, and IRB regulations, collecting, managing, and analyzing clinical data, preparing regulatory submissions and study reports, and collaborating with cross-functional teams including investigators and coordinators. This is a full-time position suitable for freshers. The benefits include health insurance. The work schedule is during the day shift and the work location is in person.,

The successful candidate will be responsible for developing and implementing regulatory strategies for new products, managing the life cycle of existing products, conducting SEC meetings, and drafting critical responses to new product queries and legal matters. Key Responsibilities: - Develop and implement overall regulatory strategy for new products. - Manage the life cycle of existing products, ensuring compliance with regulatory requirements. - Conduct SEC meetings and ensure all regulatory submissions are accurate and timely. - Draft critical responses to new product queries and legal matters. - Collaborate with cross-functional teams to ensure regulatory compliance and support product d...

JOB DESCRIPTION: Primary Job Function: To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance. Core Job Responsibilities: Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post...

You will be joining our Clinical Operations team in India, Mumbai as a full-time office-based Experienced Study Start-up Submissions Coordinator. Your role will be crucial in accomplishing tasks and projects that are essential for the success of our company. If you are seeking a rewarding career where you can utilize your expertise and further develop and grow professionally, this opportunity is perfect for you. At Medpace, we foster a culture of expertise and empowerment, allowing our teams to leverage their unique talents and experiences to approach research and problem-solving assertively, thereby supporting our business partners effectively. Our employees embody our values and commitment...

SSUA I, Bangalore, Office based ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, We are currently seeking a Study Start Up Associate I to join our diverse and dynamic team As a Study Start Up Associate I at ICON, you will play a pivotal role in facilitating the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNvative treatments and therapies, What You Will Be Doing Assisting in the preparation and submission of reg...

JOB DESCRIPTION: Job Title: Regulatory Affairs Specialist - Medical Devices Location: New Delhi Department: Regulatory Affairs Reports To: Regulatory Affairs Manager Job Summary: The Regulatory Affairs Specialist is responsible for ensuring that medical devices comply with all applicable regulations in India and international markets. This role involves preparing and submitting regulatory documents, maintaining compliance with CDSCO and other global regulatory bodies, and supporting product development teams with regulatory guidance. Key Responsibilities: Prepare, compile, and submit regulatory dossiers for product registrations, renewals, and amendments to CDSCO and other regulatory authori...

You will be responsible for responding to medical information queries, product quality complaints, and general queries received through various channels such as telephone calls, emails, and faxes. Additionally, you will receive, record, and report Adverse Drug Reactions in a timely manner, adhering to regulations and internal work instructions and standard operating procedures. Your role will involve executing drug safety data management processes, including call intake, documenting call dialogues, peer review, and case follow-up. You will also support various activities such as tracking information and metrics, quality control of process steps, training, and data reconciliation from multipl...

As an experienced professional in the pharmaceutical industry, you will be responsible for authoring, writing, and reviewing CMC sections of dossiers. Your critical review skills will be essential in examining design stage documents such as specifications, controls, and protocols to ensure compliance with regulatory requirements. You will play a key role in assessing change controls to determine their regulatory impact and develop strategies for post-approval submissions. Coordinating the collection of post-execution data from different functions and reviewing them against design specifications will be part of your daily tasks. Collaboration with cross-functional team members will be crucial...

Role & responsibilities 1. To ensure that all required information is included in the regulatory filing. 2. To collect the documents require for dossier preparation. 3.To evaluate the country wise requirements for dossier preparation as per checklist. And compile a draft dossier as per requirements and in the format provided by the authority of the country. 4.To co-ordinate with Artwork, Purchase, QC, QA, R&D, Packaging, Licensing Department for necessary documents/data. Prepare documents for courier purpose and send the courier. 5. Keep a track of the courier to check delivery on time. Providing comments on the product, preparing and submitting a regulatory application, and working with oth...

Responsibilities As a regulatory affairs officer: ensure that a company's products comply with the regulations of the regions where they want to distribute them keep up to date with national and international legislation, guidelines and customer practices respond to queries from medical bodies like the Medicines and Pertaining to that Guidelines. collect, collate and evaluate scientific data from a range of sources develop and write clear arguments and explanations for new product licences and licence renewals prepare submissions of licence variations and renewals to strict deadlines monitor and set timelines for licence variations and renewal approvals work with specialist computer software...

As a Regulatory Manager, Delivery, CMC Small Molecules Mature Products at GSK, you will play a pivotal role in leading a team dedicated to ensuring the continuous supply of essential medicines through the delivery of high-quality regulatory dossiers. Your contributions will directly impact patient care on a global scale, offering you the opportunity to collaborate with a diverse range of stakeholders, drive process enhancements, and uphold regulatory excellence. If you are proactive, detail-oriented, and enthusiastic about leadership in the realm of regulatory affairs, this position is tailored for you. Your primary responsibilities will encompass leading and nurturing your team to cultivate...

As a Manager at Velocity Clinical Research, you will play a crucial role in study start-up activities, focusing on regulatory compliance, source document delivery, and ensuring timely submission of key documents to facilitate study initiation. Your responsibilities will include managing a team of regulatory specialists, proactively addressing regulatory challenges, driving efficiency, and ensuring that regulatory submissions are completed promptly to avoid delays in study start-up. You will be involved in preparing study-specific protocol documents, informed consent forms, HIPAA authorizations, and other necessary materials for review by the Institutional Review Board (IRB). Additionally, yo...

As a Research Associate at Naari Pharma, you will play a crucial role in the execution of formulation development activities for solid dosage forms across regulated and semi-regulated markets. Your responsibilities will include conducting literature search and pre-formulation studies, evaluating innovator/RLD products, executing R&D trial batches and scale-up activities, and preparing stability batches. You will also be responsible for documentation tasks such as preparing Master Formula Cards, Product Development Reports, and Stability Protocols, as well as supporting regulatory submissions. You will work closely with cross-functional teams to monitor scale-up and exhibit batches, troublesh...

Role & responsibilities Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. Regulatory Compliance and Updates: Stay informed of changes in Asian or Regulated market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. Documentation and Record Keeping: Maintain wel...

Role & responsibilities Responsible for overseeing all 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 strategies for new drug development, including clinical trial design, data submission plans, and market access strategies. Leadi...

Job description Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Manager based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 10-15yrs. with dossier submission experience in South East Asia (Malaysia, Philippines, Thailand, Vietnam , Singapore, Lebonon, Hongkong, Brunei and Middle-East (UAE,/soudi,Iraq) Experience of regulatory submissions and life cycle management of SEA and MENA region. Interested candidate can share cv on creyesha.macwan@alembic.co.in

Job Title: Financial and Risk Reporting Group Reporting Location: Mumbai, India Role Description Group Reporting at Deutsche Bank is responsible for IFRS reporting and Regulatory Submission. The team is responsible for statutory submission like IFRS and regulatory submission like G-SIB, FINREP, HGB reports etc. Your key responsibilities Regulatory submissions for P&L related FIRNEP, and other Regulatory frameworks. Public disclosures in year-end and quarter-end reporting related to P&L topics. Preparation of movement analysis and apprising on movements to Group Finance FDs P&L related topics. Establish best practice for collaboration with various functions (including Finance CTB, TDI) to ens...

Job Summary We are seeking an experienced professional for the role of TL-Pharmacovigilance with 6 to 9 years of experience. The ideal candidate will have expertise in Pharma Research & Development and proficiency in MS Excel. Experience in PV Case Processing and Pharmacovigilance & Safety Ops is a plus. The role involves a hybrid work model with rotational shifts. Responsibilities Oversee the pharmacovigilance activities to ensure compliance with regulatory requirements and company standards. Provide expertise in Pharma Research & Development to enhance the quality and efficiency of safety operations. Utilize MS Excel to analyze and report pharmacovigilance data accurately and efficiently. ...

#hiring for a Leadership role in #RegulatoryAffairs with reputed organization into Hi-end Medical Devices industry. Job Title: Director /VP (Regulatory Affairs) Location: Gurgaon Reports To: CEO About the Role We are seeking a highly skilled Regulatory Affairs Specialist to support global regulatory activities for our advanced Medical Devices/Equipments . This role plays a key part in developing regulatory strategies, managing submissions, and ensuring ongoing compliance for Class II and III medical devices. The successful candidate will have experience working with global health authorities, especially the US FDA , and a deep understanding of the regulatory landscape for complex medical tec...

We are seeking a Principal Stat Programmer to join a leading biopharmaceutical solutions organization. This role is for a highly experienced professional who can leverage SAS and other software to develop custom programming code, manage multiple projects, and act as a technical leader for a team of statistical programmers. Roles and Responsibilities Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with project teams to resolve discrepancies. Manage scheduling and time constraints across multiple pro...

We are seeking a Principal Stat Programmer to join a leading biopharmaceutical solutions organization. This role is for a highly experienced professional who can leverage SAS and other software to develop custom programming code, manage multiple projects, and act as a technical leader for a team of statistical programmers. Roles and Responsibilities Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with project teams to resolve discrepancies. Manage scheduling and time constraints across multiple pro...

We are seeking a Principal Stat Programmer to join a leading biopharmaceutical solutions organization. This role is for a highly experienced professional who can leverage SAS and other software to develop custom programming code, manage multiple projects, and act as a technical leader for a team of statistical programmers. Roles and Responsibilities Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with project teams to resolve discrepancies. Manage scheduling and time constraints across multiple pro...

Date: 18 Aug 2025 Location: Bangalore, KA, IN, 562158 Custom Field 1: Manufacturing Services Designation: Associate Manager Job Location: Bangalore Job Grade: 7-1 (Associate Manager) The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngenes 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a...