333 Regulatory Submissions Jobs - Page 4

Key Responsibilities: 1. Regulatory Submissions & Strategy (EU Markets : Lead regulatory submissions and manage post-submission activities for EU markets. Ensure all filings and responses are compliant with applicable regulations. 2. Cross-Functional Collaboration: Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure timely and accurate preparation of regulatory submissions, including Clinical, Quality, and Nonclinical documents. 3. Regulatory Document Review: Lead the review and compilation of all relevant regulatory documents in line with local and international guidelines. Ensure technical arguments are clear and conclusions are adequately supported by data. 4. Label...

Manage daily operations of regulatory function of the assigned category Liaise with a range of colleagues from Marketing, R&D, supply, and global/regional regulatory teams. Maintain Regulatory Databases Review, interpret and assess impact of the regulatory changes. To manage compliance activities for Sustainability under Plastic waste management, Battery waste management and E-waste management rules across Reckitt entities & portfolio Preparation, maintenance and update of product registration/license and regulatory compliance files. Compilation of registration dossiers for submissions to authorities Coordination with central and state regulatory authorities/ FDAs for necessary product appro...

Job Description Job title: Regulatory Affairs Operations Specialist Your role: Assisting, supporting, coordinating and preparing regulatory submissions for product licensing to ensure accuracy and expedite approval processes and identifies, defines and addresses problems that are not immediately evident but typically not complex. The role works under general supervision, exercises independent judgment within established processes and fosters productive internal and external relationships to resolve mutual problems and contribute to streamlined operations. The role performs Change Management activities including hosting meetings to acquire change details for sustaining products, notifying geo...

As an Associate Director in Biostatistics at the company, you will play a crucial role in leading and managing the biostatistics department. You will be responsible for providing strategic direction, overseeing the team, and driving the development of innovative statistical methodologies. Your engagement with clients and stakeholders will be vital in understanding their statistical needs and ensuring efficient project execution while maintaining high-quality standards. Additionally, you will foster a culture of continuous learning and professional development within the department. **Key Responsibilities:** - Lead and supervise a team of statisticians and biostatisticians. - Set departmental...

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.

About the Role We are strengthening our Investment Banking and Transaction Advisory team and are seeking a sharp Chartered Accountant who excels at the intersection of tax, regulatory frameworks, and deal economics. You will work closely with the partners on a diverse range of mandates from transaction structuring, valuation and modelling, to regulatory representations. This role combines technical expertise in tax and regulatory matters with a strong commercial understanding of financial decisions that inform strategic deals. Key Responsibilities Support and advise on transaction structuring across mergers, acquisitions, joint ventures, and reorganisations Conduct independent research on ta...

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

Role Overview: As an Associate Director Biostatistics at Amgen, you will play a crucial role in expanding the global Biostatistics capabilities, with a key focus on integrated delivery and functional leadership. Your responsibilities will include providing statistical guidance to clinical development, overseeing statistical contributions to protocols and key trial documents, ensuring alignment with scientific rigor and regulatory requirements, collaborating cross-functionally with global teams, contributing to innovative trial designs, and executing biostatistical strategies across the product lifecycle. Your role will also involve providing consultancy and training to colleagues, supporting...

Brand Institute (BI) is the world's leading pharmaceutical branding agency, proud to be #1 in drug name approvals for 19 consecutive years. Our category-leading services include Name Strategy & Creation (USAN/INN, Brand, Clinical Trial, Program, and Line Extensions), Trademarks, Market Research, Name & Labeling Safety Research, and Visual Design. Job Description We are seeking a Medical Science Specialist to join our Nonproprietary Division. This individual would represent the company in the INN space for Europe & Asia clients , assisting those regional sales teams in client presentations and providing INN nonproprietary naming and regulatory expertise. The position requires specific and in-...

Role & responsibilities You will lead the regulatory activities for all Convatec products including product registration (new, renewal and amendment), product promotional activities, labeling review activities, product registration and listing database. Location: Gurgaon Key duties and responsibilities Develop regulatory strategy and update the strategy based upon regulatory changes and business needs. Manage and execute regulatory compliance activities as required by the local regulations Compile, prepare, review and submit regulatory submissions to the local health authorities as well as to identify issues early in the submission preparation process that could impact product launch Monitor...

Role Overview: You will be a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations). Your primary responsibility will involve developing and executing global regulatory strategies for combination product devices. Your focus will be on ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. Key Responsibilities: - Provide regulatory guidance on device design, human factors, risk management, and manufacturing considerations. - Lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. - E...

As an Experienced Study Start up Submissions Coordinator at Medpace, you will play a crucial role in the activation of investigative sites for clinical trials in India Mumbai. Your expertise will be utilized to prepare, review, and submit documents to Regulatory Agencies, ensuring compliance with applicable regulations and guidance documents. You will be the main contact for Ethical and Regulatory submission-related activities, providing guidance to global study teams and sponsors on changing regulations and compliance requirements. **Key Responsibilities:** - Perform activities within the country leading to site activations in clinical trials - Communicate with global study teams and person...

Role Overview: As a local Study Associate Director at AstraZeneca, you will play a crucial role in the development, maintenance, and project management of the study management process and technology required in clinical trials. Your responsibilities will include acting as a regional technical expert, leading the delivery of all components of a clinical study, and enhancing the effectiveness of study management contributions to worldwide submissions across a range of products. Additionally, you will be responsible for applying expert statistical skills to support internal proposal development and external regulatory submissions while keeping your knowledge of best practices up to date. Key Re...

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...

Company Description Syngenta We are a leading, science-based agriculture company, empowering farmers to meet the demands of modern agriculture. Using cutting-edge innovation, we help farmers to grow resilient, healthy crops that can feed a growing global population, while promoting sustainable farming practices that protect and enhance our planet. Headquartered in Switzerland, we are a global agritech leader with more than 30,000 employees across over 90 countries. https://www.syngenta.com/company Job Description This role requires > 8 years of experience working in the areas of pesticide/agrochemical formulation development and able to work in the formulation lab. Lead the development of Cr...

Education: Bachelors Degree in Life Sciences or related field Markets: US/UK/EU/ROW Job Summary: We are seeking a detail-oriented and proactive Associate - Regulatory Affairs (RA) Publishing with 1-3 years of experience in regulatory submissions across global markets including the US, UK, EU, and ROW (Rest of World). The ideal candidate will have a background in Life Sciences and possess hands-on experience with eCTD/aCTD submissions. This role is crucial for facilitating on-time submissions, executing submission build activities, and ensuring compliance with regulatory requirements. Key Responsibilities: Prepare, review, and compile regulatory submissions in eCTD/aCTD formats for various ma...

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 approval changes e...

Concept Medical is a leading developer and manufacturer of innovative medical devices specializing in interventional cardiology and radiology. Your role as a Regulatory Specialist will involve ensuring that our products comply with both local and international regulatory standards such as CDSCO, ISO, and FDA. Your expertise will be crucial in maintaining the highest levels of safety and efficacy for our stents and balloon catheters. Key Responsibilities: - Develop regulatory strategies for new and existing products to meet compliance requirements. - Ensure adherence to local and international regulations including CDSCO, ISO, and FDA. - Prepare and submit regulatory documentation and filings...

As a Regulatory Administrator at our company, you will play a vital role in providing administrative and operational support to the Regulatory Affairs department to ensure the smooth facilitation of the regulatory submissions process. Your responsibilities will include: - Uploading, organizing, and maintaining regulatory documents within various regulatory authority submissions portals such as CTIS, FDA eGateway, and CESP. - Coordinating the redaction of confidential information in regulatory documents and ensuring compliance with global standards. - Collaborating with external vendors for document redaction services and monitoring the progress of redaction processes. - Assisting in preparin...

Ensure compliance with GMP, FDA, and other regulatory standards Conduct quality checks on raw materials, in-process materials, and finished products Ensure compliance with regulatory requirements for drug development, manufacturing, and marketing.

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

REQUIRE EXPERIENCE IN MODULE 1 COORDINATION AND SUBMISSIONS. MAIN PURPOSE OF ROLE Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. MAIN RESPONSIBILITIES As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liai...

As an Upstream Manufacturing Documentation at Syngene, your role will involve leading the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. You will provide expert leadership overseeing strategic and day-to-day activities in upstream process development of complex novel biologics. Your responsibilities will include overseeing technology transfer to support scale-up and GMP manufacturing, building strong relationships with CMOs, designing and executing risk-based process characterization studies, scaling up processes, preparing technology transfer protocols, collaborating with other teams, liaising with regulatory affair...

As a Quality Assurance Manager at Apotex Inc., you will be responsible for ensuring the effective review and approval of various quality control processes. Your key responsibilities will include: - Reviewing and approving lab investigation reports, deviations, questionable results, out of specification (OOS) and out of trend (OOT) investigations. - Preparing and reviewing standard operating procedures. - Coordinating with cross-functional teams for the closure of investigations in a timely manner. - Reviewing and approving change controls, lab events, and temporary changes. - Coordinating with the regulatory department for submissions and post-approval changes. - Identifying system improveme...

As a Medical Writer at our company, you will play a crucial role in creating high-quality documents for clinical trials, regulatory submissions, publications, and other scientific materials. Your strong background in scientific writing and deep understanding of medical and healthcare concepts will be instrumental in this role. You will collaborate closely with cross-functional teams to ensure the accuracy, clarity, and compliance of all documents. - Write and edit various medical and scientific documents such as clinical study reports, regulatory submissions, and research papers. - Ensure that all documents meet regulatory requirements and company standards. - Collaborate with researchers, c...