40 Regulatory Strategies Jobs - Page 2

Job Description Summary Join GE HealthCare as a Lead Specialist in Regulatory Affairs and play a pivotal role in shaping the future of medical imaging. This global leadership position offers the opportunity to drive regulatory strategies and lead cross-functional teams to bring innovative X-ray imaging products to market. Be part of a dynamic environment where your expertise will directly impact patient care and healthcare outcomes worldwide. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice ...

Job Title: Head Regulatory Affairs Location: Daman About the client: PSS has been mandated to hire a Head of Regulatory Affairs for a leading R&D backed, manufacturing women's health organization with operations in over 140 countries worldwide. It is the world's largest manufacturer of Contraceptives devices. Job Purpose The Head of Regulatory Affairs will lead global regulatory strategies for medical devices and contraceptive solutions. The role will ensure compliance with domestic and international regulations (and support product approvals, quality assurance, and market expansion. Key Responsibilities Regulatory Strategy & Compliance: Develop and implement regulatory strategies for medica...

Position Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in emerging markets. Key Activities required for this job are as below Develop and implement regulatory strategies for biosimilar products in LATAM. Prepare, review, and submit dossiers for marketing authorization applications (MAAs), renewals, and variations in compliance with local requirements. Ensure adherence to regional regulatory reu...

Role Overview: You will be responsible for the CMC review of technical documentation for regulatory filings across various markets including the US. This will involve conducting Gap Analysis and Remediation for Module 3 - CMC. Additionally, you will play a key role in the development and implementation of regulatory strategies, processes, and timelines for the grant of Marketing Authorization in regions such as Africa, GCC, LATAM, and ASEAN. Key Responsibilities: - Reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. - Critically reviewing documentation intended for s...

Responsibilities Develop and implement regulatory strategies to ensure compliance with all applicable laws and regulations in the construction industry Monitor and evaluate regulatory requirements for construction projects and provide guidance to project teams Coordinate with internal teams, external consultants, and regulatory authorities to obtain necessary approvals and permits Review and interpret regulatory documents and communicate requirements to stakeholders Conduct audits and inspections to assess compliance with regulatory standards and implement corrective actions as needed Stay updated on changes in regulatory requirements and proactively address potential compliance issues Prepa...

You are a detail-oriented RA-CMC Associate responsible for supporting end-to-end submissions for global markets. Your expertise includes Lifecycle Management (LCM), Veeva Vault RIM, and managing complex Initial and Variation submissions. Your key responsibilities will involve preparing Variation documents and/or evaluating post-approval CMC changes to ensure compliance with global regulatory requirements. You will play a significant role in Lifecycle Management (LCM) activities by assisting in compiling and reviewing CTD dossier modules. Your tasks will also include compiling initial dossiers (Modules 2 & 3) for various countries such as US, EU, SA, WHO, ANZ, and others. You will be expected...

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed...

As a Drug Regulatory Affairs Specialist at MEDYUR PHARMACEUTICALS LIMITED, you will be responsible for ensuring compliance with regulatory requirements for our products. Your role will involve collaborating with cross-functional teams to drive successful product launches and maintain regulatory compliance. Your responsibilities will include preparing and submitting regulatory documentation, staying updated on global regulatory requirements, developing relationships with regulatory bodies, reviewing changes in regulatory policies, conducting regulatory impact assessments, maintaining regulatory files, and supporting regulatory inspections and audits. You will also collaborate with internal te...

You are a proactive and detail-oriented Assistant Manager in Regulatory Affairs (EU & UK) with a Masters Degree in Pharmacy (M.Pharm or equivalent) having 4 to 6 years of experience. You will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets, ensuring compliance with regional and international guidelines. Your key responsibilities will include conducting comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets, performing Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards, developing and implementing ...

You will be responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products. Your key duties will include overseeing global CMC regulatory activities for assigned projects, developing CMC strategy for submission documents, ensuring regulatory compliance, and participating in cross-functional project teams to define proper regulatory CMC filing strategy. Additionally, you will be expected to maintain high-quality standards, seek continuous improvement, share best practices within the CMC Regulatory teams, and engage in CMC Subject Matter Expert activities. To excel in this role, you should have a minimum level of job-related e...

At Lilly, the focus is on uniting caring with discovery to improve the lives of individuals worldwide. As a global healthcare leader headquartered in Indianapolis, Indiana, the organization is committed to developing and delivering life-changing medicines, enhancing disease management, and giving back to communities through philanthropy and volunteerism. The team at Lilly prioritizes putting people first and is dedicated to making a positive impact on a global scale. The Product Research and Development (PRD) organization at Lilly is instrumental in the development and delivery of quality medicines to patients. The diverse portfolio includes the development and commercialization of various m...

As a Regulatory Compliance Specialist in the construction industry, your role will involve developing and implementing regulatory strategies to ensure compliance with all applicable laws and regulations. You will be responsible for monitoring and evaluating regulatory requirements for construction projects and providing guidance to project teams. In this position, you will coordinate with internal teams, external consultants, and regulatory authorities to obtain necessary approvals and permits. Your responsibilities will also include reviewing and interpreting regulatory documents, as well as communicating requirements to stakeholders. As a Regulatory Compliance Specialist, you will conduct ...

This is a full-time on-site role for a Manager / Deputy Manager Regulatory Affairs located in Vadodara. As the Manager / Deputy Manager, your responsibilities will include developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. Your role will involve interacting with regulatory agencies, managing timelines, and ensuring that all products meet regulatory standards. Your key responsibilities will be to develop and direct global regulatory strategies for clinical, non-clinical, and CMC aspects. You will lead the preparation, review, and approval of submission documents f...

The candidate will be responsible for researching, analysing, and summarizing complex regulatory information, translating it into insightful and compliant reports. You will research and monitor regulatory requirements, guidelines, and industry trends from agency websites. Additionally, you will analyse and interpret regulatory information, provide concise and accurate summaries, and prepare high-quality regulatory intelligence. It is important to maintain up-to-date knowledge of global regulations and standards, contribute to regulatory strategies, and ensure timely delivery of reports. Qualifications for this role include a BSc/B. Pharm in a related field such as Life Sciences, Pharmacy, Re...

Provide Leadership and coordinate with cross functional teams to deliver Safe,Effective & Regulatory compliant Products to customers following the QCDMSES (quality, cost, delivery, development, management, safety, environment Required Candidate profile BE or BTech. or high or equivalent Degree. MBA is added preference.Working Knowledge of Regulatory Resources & Added certifications Ex: RAPS, regulatory trainings and certifications. Working knowledge