333 Regulatory Submissions Jobs - Page 5

Job Description Role Overview: As a Sr Manager Drug Regulatory Affairs at Jaidev Pharma Placement, your primary responsibility will be to ensure regulatory compliance and manage regulatory requirements. You will oversee regulatory affairs, handle regulatory submissions, and maintain the quality system. This is a full-time on-site role located in Chandigarh. Key Responsibilities: - Ensure regulatory compliance - Manage regulatory requirements - Oversee regulatory affairs - Handle regulatory submissions - Maintain the quality system Qualifications Required: - Regulatory Compliance and Quality System management experience - Understanding and implementing Regulatory Requirements - Proficiency in...

As a highly skilled and motivated analytical scientist, you will join the Vaccine Product Development organization as a staff scientist within Protein Development and Clinical Manufacturing at our client's vaccine innovation company. Your primary role will be to lead efforts in analytical development and method qualification for measuring tier, impurities, and product quality for in-process intermediates. Additionally, you will strategize the measurement of attributes crucial for successful process characterization and validation in protein manufacturing processes. Your responsibilities will also include managing a team of scientists and research associates, providing scientific mentorship, ...

Lead the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. Provide expert leadership overseeing both strategic and day-to-day activities in upstream process development of complex novel biologics. Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance. Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs). Scale-up process from laboratory-scale bioreactors to pilot and commercial-scale, ensuring process robust...

Role & responsibilities : Review of all QMS documents related to regulatory submissions Prepare status of all documents related to submission Co-ordinate with all stakeholders of plant for collection of documents Provide all regulatory documents to HO-RA for submission. Evaluation of change control, deviations and out of specifications. Review of specifications, BMRs, BPRs, COA, Method transfer report, Method verification/validation report, Analytical chromatograms, Sterility assurance data package. General Review of plant equipment qualifications, filter validation documents and layouts for its adequacy to support regulatory submission. To facilitate LoA, Debarment certificate, GMP certific...

Roles and Responsibility Coordinate and manage regulatory submissions, ensuring compliance with relevant laws and regulations. Develop and implement effective submission strategies to achieve business objectives. Collaborate with cross-functional teams to ensure timely and accurate submissions. Conduct thorough reviews of submissions to identify areas for improvement. Maintain accurate records of submissions and follow up on pending submissions. Stay updated with changes in regulatory requirements and guidelines. Job Requirements Strong knowledge of regulatory submissions and compliance. Excellent communication and project management skills. Ability to work in a fast-paced environment and me...

Roles and Responsibility Publish regulatory submissions on time, ensuring accuracy and compliance with relevant regulations. Collaborate with cross-functional teams to prepare and review regulatory documents. Develop and maintain relationships with regulatory authorities and stakeholders. Stay updated with changes in regulatory requirements and implement necessary updates. Ensure all regulatory submissions meet required standards and quality criteria. Coordinate with internal teams to gather information and support for regulatory submissions. Job Requirements Strong knowledge of regulatory requirements and guidelines. Excellent communication and interpersonal skills. Ability to work independ...

Role & responsibilities Managing Teams handling SEBI-SCORES / ODR Complaints Data Maintenace of complaints received from SEBI/Exchanges/Depositories Handling Audit & Inspections from SEBI/Exchanges/Depositories time to time Co-ordinate with internal stakeholders & regulators for complaint resolution Adherence of all monthly quarterly regulatory submissions Align with internal teams for process improvements Problem solving approach People management

What Will You Do: Assess regulatory intelligence for supporting development of local, regional, and global regulatory strategies. Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle to ensure product compliance and anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions. Assist in the development of regulatory strategy and update strategy based upon regulatory changes. Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities. Provide regulatory information and guidance for product development and pla...

Roles and Responsibility Publish regulatory submissions according to company guidelines and timelines. Ensure compliance with regulatory requirements and industry standards. Collaborate with cross-functional teams to meet submission goals. Review and edit regulatory documents for accuracy and completeness. Maintain accurate records of submissions and publications. Stay updated with changing regulatory requirements and guidelines. Job Requirements Minimum 2 years of experience in regulatory submissions or a related field. Strong knowledge of regulatory requirements and industry standards. Excellent publishing and communication skills. Ability to work independently and as part of a team. Stron...

Roles and Responsibility Coordinate and manage regulatory submissions, ensuring compliance with relevant laws and regulations. Develop and implement effective submission strategies to achieve business objectives. Collaborate with cross-functional teams to ensure timely and accurate submissions. Conduct thorough reviews of submissions to identify areas for improvement. Maintain accurate records of submissions, approvals, and other relevant documents. Stay up-to-date with changes in regulatory requirements and guidelines. Job Requirements Strong knowledge of regulatory submissions and compliance. Excellent communication and project management skills. Ability to work effectively in a fast-paced...

Roles and Responsibility Coordinate and prepare regulatory submissions for timely and accurate filing. Develop and maintain relationships with regulatory authorities and stakeholders. Conduct thorough reviews of regulatory documents to ensure accuracy and completeness. Collaborate with cross-functional teams to meet regulatory requirements. Stay updated on changing regulatory requirements and implement necessary changes. Ensure compliance with all relevant laws and regulations. Job Requirements Strong knowledge of regulatory requirements and guidelines. Excellent communication and coordination skills. Ability to work independently and as part of a team. Strong analytical and problem-solving ...

Roles and Responsibility Coordinate and manage regulatory submissions, ensuring compliance with relevant laws and regulations. Develop and implement effective submission strategies to achieve business objectives. Collaborate with cross-functional teams to ensure timely and accurate submissions. Conduct thorough reviews of submissions to identify areas for improvement. Maintain accurate records of submissions, approvals, and other related documents. Stay up-to-date with changes in regulatory requirements and guidelines. Job Requirements Strong knowledge of regulatory submissions and compliance. Excellent communication and project management skills. Ability to work effectively in a fast-paced ...

What You'll Do Lead regulatory submissions & approvals with agencies (EMA, ANVISA, TGA, SFDA, etc.) Define regulatory strategies for new launches and lifecycle management Drive in-licensing & out-licensing due diligence to support business growth Ensure compliance with EU & EM regulations, staying ahead of evolving requirements Mentor and manage a global regulatory team, working cross-functionally with R&D, Clinical, QA, Commercial & BD What We're Looking For 16+years of Regulatory Affairs experience (pharma/biotech/medical devices) Strong exposure to EU & Emerging Market submissions Hands-on experience in licensing due diligence & authority interactions Proven leadership and people manageme...

Roles and Responsibility Publish regulatory submissions to relevant authorities, ensuring compliance with required standards and regulations. Collaborate with cross-functional teams to prepare and review regulatory documents, including applications, reports, and other submissions. Develop and maintain relationships with regulatory bodies and respond to queries related to regulatory submissions. Stay updated on changes in regulatory requirements and implement necessary updates to ensure compliance. Review and edit regulatory documents for accuracy, completeness, and adherence to company policies. Coordinate with internal stakeholders to gather information and support for regulatory submission...

Roles and Responsibility Coordinate regulatory submissions with cross-functional teams to ensure timely and accurate delivery. Develop and maintain relationships with regulatory authorities and stakeholders. Prepare and review regulatory documents, including applications, reports, and other submissions. Ensure compliance with regulatory requirements and guidelines. Collaborate with internal teams to resolve issues related to regulatory submissions. Maintain accurate records of regulatory submissions and interactions. Job Requirements Minimum 2 years of experience in regulatory submissions or a related field. Strong knowledge of regulatory requirements and guidelines. Excellent communication ...

Roles and Responsibility Publish and submit regulatory documents to relevant authorities. Ensure compliance with regulatory requirements and guidelines. Coordinate with cross-functional teams to prepare and review regulatory submissions. Maintain accurate records of regulatory submissions and correspondence. Stay updated with changes in regulatory requirements and implement updates accordingly. Collaborate with internal stakeholders to ensure timely submission of regulatory documents. Job Requirements Minimum 3 years of experience in regulatory submissions or a related field. Strong knowledge of regulatory requirements and guidelines. Excellent communication and coordination skills. Ability ...

Roles and Responsibility Manage and publish regulatory submissions, ensuring compliance with relevant laws and regulations. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Develop and maintain relationships with regulatory authorities and other stakeholders. Stay updated on changes in regulatory requirements and implement necessary updates. Ensure accurate and high-quality content in all regulatory submissions. Collaborate with internal teams to resolve issues related to regulatory submissions. Job Requirements Strong knowledge of regulatory requirements and guidelines. Excellent communication and interpersonal skills. Ability to work independently...

As the Director of AI Solutions at Syneos Health, your role will involve defining and executing the AI roadmap for clinical research and trials in alignment with CRO business objectives. You will be responsible for identifying AI opportunities in patient recruitment, site selection, risk-based monitoring, and real-world evidence analytics. Your key responsibilities will include: - Leading the design and deployment of AI/ML models for predictive enrollment, protocol optimization, and adverse event detection - Ensuring solutions comply with GxP, HIPAA, GDPR, and global regulatory requirements - Partnering with clinical operations, data management, and biostatistics teams to integrate AI into t...

Job Description: Amgen is a leading human therapeutics company in the biotechnology industry For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle...

Formulation Experience Mandatory: Well aware of EU, Australia, Ukraine & UK market requirement Dossier Preparation in ACTD & CTD Format ICH guidelines Communication skills Documents Management Stakeholder Communication

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Th...

About The Role : In Scope of Position based Promotions (INTERNAL only) Job TitleNCT - LDMR - Liquidity Data Measurement LocationPune, 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 liqu...

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...

Role Overview: The ideal candidate for the Biostatistician role should possess a Master's degree in Statistics or equivalent. A Ph.D. in Statistics or equivalent combined with 6 years of industry-related experience is also a preferred qualification. With at least 9+ years of experience, you must demonstrate a deep understanding of statistical and clinical trials methodology as it pertains to clinical development. As a Biostatistician, you will be an integral part of cross-functional development teams, contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. Your role will involve collaborating with various st...

Role Overview: As an intern at Noccarc Robotics, your role will involve conducting clinical validation tests of ICU ventilators, patient monitors, and other critical care devices in hospital and laboratory settings. You will collaborate with intensivists, respiratory therapists, and ICU staff to assess product performance. Additionally, you will be responsible for designing and executing ex-vivo and in-clinic testing protocols to validate device functionality, accuracy, and safety. Key Responsibilities: - Collect, analyze, and interpret clinical data to provide insights for product improvements. - Document findings, prepare validation reports, and contribute to regulatory submissions. - Iden...