333 Regulatory Submissions Jobs - Page 2

preparation and submission of registration dossier, renewal application and variation application for ANDA / ROW submission Preparation of respective CTD sections and submission of final query response to agency Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval To upload documents in national portal for respective European regulatory agency Co-ordination with different department for getting required data for compilation of registration dossier, renewal application and variation Review of the mockups for all regulatory submissions and commercial supplies Maintenance of internal database Co-ordination with consulta...

Role Overview: You will lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Your responsibilities include end-to-end report management, planning, authoring, managing review and submission steps, applying safety domain knowledge, managing deliverables of medium to high complexity, and ensuring timely delivery of high-quality documents to internal customers and sponsors/clients. You will coordinate activities related to several types of report writing across a team of writers, perform support activities such as tracking, maintenance of metrics, quality checks, and training, and assist Medical Writers in preparing safety r...

As a Senior Compliance Professional at Aikyam Capital, you will play a crucial role in ensuring trust, governance, and integrity through compliance practices. Your responsibilities and qualifications are outlined below: Role Overview: - Lead and manage compliance programs across multiple verticals - Ensure adherence to SEBI, Exchange regulations, and internal policies - Review SOPs, policies, agreements to align with compliance standards - Drive internal audits, risk assessments, and training initiatives - Oversee regulatory submissions, CTCL, ALGO, COLO, and exchange approvals - Act as the key liaison between leadership, regulators, and industry bodies Key Responsibilities: - CS and/or LLB ...

As a Regulatory Affairs Manager at Ferring India Laboratories, you will be responsible for the following key responsibilities: - Prepare, compile, and submit regulatory dossiers and submission data. - Manage Test and Manufacturing License applications with state and central drug authorities. - Handle regulatory submissions, variation filings, technical report writing, and query responses. - Ensure compliance with Drugs & Cosmetics Act, New Drug & Clinical Trial (CT) Rules, and GMP guidelines. - Ensure adherence to national and international regulatory requirements. - Review product labeling and artworks for regulatory compliance. - Liaise with state and central regulatory bodies (e.g., CDSCO...

As an Associate II in Complex Gx, Regulatory Affairs at Teva Pharmaceuticals, you will be responsible for the preparation and submission of high-quality regulatory filings for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. Your role will involve managing regulatory submissions, collaborating with cross-functional teams, evaluating change controls, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. Additionally, you may serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives. Key Responsibilities: - Prepare, review, and compile new submis...

As a Clinical Trials Assistant, your role will involve assisting in the preparation and coordination of clinical trial protocols and associated documents. You will support the monitoring of clinical trials at various stages, including site initiation, maintenance, and close-out. Your responsibilities will include ensuring that study sites are compliant with Good Clinical Practice (GCP) and regulatory requirements. Additionally, you will conduct site visits to assess the progress of clinical trials, monitor data accuracy, and ensure patient safety. Key Responsibilities: - Assist in the review and management of clinical trial documentation, including case report forms (CRFs), informed consent ...

Why Quark Software: At Quark, we've been revolutionizing graphic design, digital publishing, and content automation since 1981. With over four decades of expertise, we empower organizations to master their content lifecycle through cutting-edge design, automation, and intelligence. Our software solutions enable customers to create, manage, publish, and analyse their content with unrivalled effectiveness. As we embark on an exciting new era of growth, we're on the lookout for exceptional individuals to join our Global team. Why Choose Quark: Quark is entering a transformative phase of growth, driven by visionary leadership focused on research and development and customer success. Our culture ...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for the product life-cycle management of Apotex products (Toronto) ...

Job Title: Statistical Programmer Location : Mumbai / Pune / Bangalore Experience : 3 - 7 years Industry : Pharmaceuticals / Biotechnology / Clinical Research About the Role We are looking for an experienced Lead Statistical Programmer to oversee programming activities for clinical trials, regulatory submissions, and integrated analyses. This role involves leading a team, ensuring high-quality deliverables, and developing efficient programming standards to support drug development. Key Responsibilities Lead statistical programming activities for a compound or therapeutic area. Manage, mentor, and guide a team of statistical programmers. Create and validate analysis data sets (ADaM), tables, ...

Company Description Dyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment. Role Description This is a full-time on-site role for a Senior Regulatory Affairs Specialist, located in Hyderabad . The Senior Regulatory Affairs Specialist will be responsible for managing regulatory documentation, ensuring regulatory compliance, overseeing regulatory submissions, and staying updated with regulatory requirements. This role involves coordinating with various departments to ensure all regulat...

Site Name: Bengaluru Luxor North Tower Posted Date: Oct 16 2025 Business Introduction: At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. We're uniting science, technology, and talent to ge...

Company Description At Novaspire, we pride ourselves on being a trusted partner to the pharmaceutical industry, dedicated to delivering comprehensive, high-quality clinical research services. We support pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the product development lifecycle, from Phase I clinical studies to post-market surveillance. Our core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services and training, and imaging studies. We are committed to ensuring patient safety, regulatory compliance, and high-quality data to enhance clinical trial outcomes. Role Description...

This is where your work makes a difference. At Baxter, we believe every personregardless of who they are or where they are fromdeserves 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. He...

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal.?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.?Learn more at ht...

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...

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 Support:(PRIMARY) ...

ICAAP and ILAAP Senior Consultant FS Risk Consulting - MENA About the job At EY, youll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And were counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. I CAAP & ILAAP Senior Consultant, FS Risk Consulting - MENA Job Summary We are looking for an experienced regulatory policy consultant to assist Banks in Middle East in refining and formalizing its supervisory expectations for the Internal Capital Adequacy Assessment Proc...

Job Description: In Scope of Position based Promotions (INTERNAL only) Job Title: LDMR - Liquidity Data Measurement- NCT Location: Pune, India Business Description It is crucial for the bank to understand how profitable each businesses activity is and Finance has a responsibility to understand precisely the resource commitment the bank makes to any given client or transaction e.g. cost, capital, funding, liquidity and risk. Finance is playing a central role in keeping the bank focused on simplification and financial resource management. Liquidity Data Measurement and Reporting (LDMR) is an integral part of the banks liquidity reporting framework responsible for regulatory interpretation of l...

Client-Focused Project Execution: Lead packaging development projects based on customer specifications, regulatory requirements, and timelines. Serve as the primary technical interface between internal teams and client stakeholders. Translate customer needs into actionable packaging solutions and ensure timely delivery. Technical Leadership: Design, develop, and validate packaging systems Ensure packaging meets functional, regulatory, and sustainability standards. Oversee testing protocols, including transit, shelf-life, etc. Team & Process Management: Lead and mentor a team of packaging engineers and technicians. Coordinate cross-functional efforts across design, quality, procurement, and o...

Role Overview: As a highly skilled and experienced Developer/Analyst specializing in Quality Management Systems (QMS), you will primarily focus on Java-based application development within areas such as Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions. Your expertise in supporting, developing, and administering Trackwise EQMS and similar QMS will be essential for this role. Additionally, familiarity with SAP ABAP is desired to facilitate seamless interfaces between the EQMS system and SAP. Key Responsibilities: - System Support and Administration: - Provide development support for Trackwise EQMS and related QMS applications. - Administer and m...

Role Overview: You should have a good knowledge of ANDA submission activities and post-approval procedures along with related ICH and USFDA guidelines. Your responsibilities will include API DMF review in accordance with USFDA regulatory requirements, exposure to various dosage forms, preliminary review of change cases, drafting annual reports, reviewing submission packages, drafting controlled correspondence, and ensuring regulatory submissions are completed without delay. Coordination with cross-functional teams and maintaining regulatory information will also be part of your role. Key Responsibilities: - Review API DMF with respect to USFDA regulatory requirements - Understand and brief m...

As a Manager - Performance and Reward Operations at HSBC, you will play a crucial role in supporting the Group team by providing essential analysis and information. Your responsibilities will include: - Assist with analysis and preparation of information for Material Risk Taker, Compensation data, and Emoluments - Monitor team mailboxes and MS Teams channels, responding to process-related queries - Consolidate data from regional/business submissions, perform data analysis and manipulation, generate reports, and produce Management Information (MI) for operational or regulatory submissions - Prepare compensation data based on requests from management and regulators - Exhibit ownership of your ...

Job Summary: The Regulatory Affairs Manager will oversee all regulatory compliance activities related to the companys nutraceutical products, ensuring that all the marketing practices meet applicable global standards (e.g., FDA (U.S.), EFSA (EU), FSSAI (India) . Key Responsibilities: Regulatory Strategy & Compliance. Develop and implement regulatory strategies for product launches and market expansions. Ensure the certifications are renewed on time and also apply for new certifications in new geographies. Interpret and apply country-specific regulations (FDA/DSHEA, EFSA, FSSAI, etc.) to ensure compliance. Dossier & Documentation Management. Prepare and maintain regulatory submissions, includ...

Role & responsibilities Dossier and regulatory document preparation Regular discussion and interactions with customer's regulatory team to answer queries regarding documentations Visiting FDA office for follow ups on applications Preferred candidate profile Deep knowledge of regulatory frameworks in Southeast Asia (especially the ACTD structure), Africa, and Latin America, and ability to interpret country-specific requirements for dossier submissions. Proficiency in preparing, compiling, and presenting regulatory dossiers (including administrative, quality, nonclinical, and clinical sections) according to the ACTD and local formats. Strong documentation management, including version control,...

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. Review and approve produ...