Regulatory Affairs
3 weeks ago
Roles and Responsibilities DMF submissions Annual Reports Variations Renewals etc for US and Europe market Compilation and publishing in eCTD CTD format for Submission to health agencies like EDQM USFDA etc Oversee final technical quality review and technical validation PDF eCTD NeeS Review all regulatory agency submission materials for accuracy comprehensiveness or compliance with regulatory standards Provide deficiencies responses to HA regulatory agencies for deficiencies and comments Evaluation of change controls for post-approval changes PAC Compilation review and submission of Variations Keeping up to date with changes in regulatory legislation and guidelines Conduct Pre-submission and Initial Submissions meetings Preparation of gap analysis report of CMC regulatory submission including recommendations to facilitate the review of application by HA Gaps in manufacturing and controls assessment of regulatory risk and strategy Providing gap analysis against applicable HA requirements and standards and communicate cross functional team to comply the samezCharacterization of the API and Raw materials used to manufacture the API Description of the product and process development Analytical methods and specifications used for testing Release and stability testing data for both the API Preparation of responses to HA comment letters assessment reports Initial assessment of the submission initial post approval submissions E g initial validation comments response to the completeness assessment report response to the Information Requests Ciel HR
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Regulatory Affairs Director
3 weeks ago
Hyderabad, Telangana, India Demo S.A. Full timeDEMO S.A. Pharmaceutical Industry is an industrial and commercial organization currently establishing a Corporate Center in Hyderabad, India. This center will provide high-quality support services across multiple functions and capabilities to our headquarters in Greece.In the initial phase, the office will focus on Regulatory Affairs, supporting the...
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Regulatory Affairs Director
3 weeks ago
Hyderabad, Telangana, India Demo S.A. Full timeDEMO S.A. Pharmaceutical Industry is an industrial and commercial organization currently establishing a Global Services Center in Hyderabad, India. This center will provide high-quality support services across multiple functions and capabilities to our headquarters in Greece and subsidiaries in Europe.In the initial phase, the office will focus on Regulatory...
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Regulatory Affairs Director
2 weeks ago
Hyderabad, Telangana, India Demo S.A. Full timeDEMO S.A. Pharmaceutical Industry is an industrial and commercial organization currently establishing a Global Services Center in Hyderabad, India. This center will provide high-quality support services across multiple functions and capabilities to our headquarters in Greece and subsidiaries in Europe.In the initial phase, the office will focus on Regulatory...
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Regulatory Affairs Specialist
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Regulatory Affairs Specialist Job Location: Hyderabad, Telangana, India Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent...
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Regulatory Affairs Specialist
3 weeks ago
Hyderabad, Telangana, India Medtronic Full timeCareers that Change Lives Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations. Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met. Responsible for supporting the needs of the MEIC with regulatory support for research and...
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Regulatory Affairs Specialist
2 weeks ago
Hyderabad, Telangana, India Medtronic Full timeCareers that Change LivesCollaborate and partner with Design QA R D Sustaining Engineering Clinical Affairs Marketing and Operations Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met Responsible for supporting the needs of the MEIC with regulatory support for research and...
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Regulatory Affairs Assistant
2 days ago
Hyderabad, Telangana, India Gamut HR Solutions Full timeCompany OverviewGamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at http://gamuthrsolutions.com/.Job OverviewWe are seeking a Mid-Level Regulatory Affairs Assistant to join...
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Regulatory Affairs Intelligence Mgr
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Regulatory Affairs Intelligence Mgr Job Location: Hyderabad, Telangana, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Global Regulatory Policy and Intelligence engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance...
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Regulatory Affairs Specialist
4 weeks ago
Hyderabad, Telangana, India Medtronic Full timeAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world A Day in the LifeRegulatory Affairs Specialist-IICareers that Change LivesCareer growth and development is about...
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Regulatory Affairs Specialist
4 weeks ago
Hyderabad, Telangana, India Medtronic Full timeAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youxe2x80x99ll lead with purpose breaking down barriers to innovation in a more connected compassionate world A Day in the LifeRegulatory Affairs Specialist-IICareers that Change LivesCareer growth and development is...
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Regulatory Affairs Specialist
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Regulatory Affairs Specialist - 2 Job Location: Hyderabad, Telangana, India Job Location Type: Hybrid Job Contract Type: Full-time Job Seniority Level: Associate At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down...
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Regulatory Affairs Intelligence Mgr
4 weeks ago
Hyderabad, Telangana, India Amgen Full timeCareer Category ClinicalGlobal Regulatory Policy and Intelligence engages regulators industry and professional associations and patient advocates externally and subject matter experts across Amgen to advance important Regulatory policy issues aligned with Amgens goals and priorities Regulatory Intelligence for the GRAAS organization enables fast ...
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Regulatory Affairs Intelligence Mgr
2 weeks ago
Hyderabad, Telangana, India Amgen Full timeGlobal Regulatory Policy and Intelligence engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important Regulatory policy issues aligned with Amgen's goals and priorities. Regulatory Intelligence for the GRAAS organization enables fast, efficient global filings by...
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Regulatory Affairs Manager
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Regulatory Affairs Manager Job Location: Hyderabad, Telangana, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and...
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Regulatory Affairs Analyst
3 weeks ago
Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full timeJob DescriptionWe are looking for a Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals.This role is pivotal in managing activities pertaining to new application submissions for Europe through DCP, MRP, NP. Collaboration with European Regulatory authorities and internal...
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Global Regulatory Affairs Specialist
2 days ago
Hyderabad, Telangana, India Novartis Full timeRegulatory Affairs Role:In this critical role, you will be responsible for ensuring that Novartis' products comply with regulatory requirements. As a Regulatory Compliance Manager, you will develop and implement global CMC regulatory strategies, lead global CMC submission activities, and collaborate with cross-functional teams to ensure alignment and...
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Manager, Regulatory Affairs
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Manager, Regulatory Affairs - CMC Job Location: Hyderabad, Telangana, India Job Location Type: Hybrid Job Contract Type: Full-time Job Seniority Level: Job DescriptionManager, Regulatory Affairs - CMCThe incumbent is expected to be knowledgeable in project management principles, manufacturing change control management and CMC dossier structure...
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Manager, Regulatory Affairs
2 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Manager, Regulatory Affairs - CMC Job Location: Hyderabad, Telangana, India Job Location Type: Hybrid Job Contract Type: Full-time Job Seniority Level: Job DescriptionManager, Regulatory Affairs - CMCThis Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations,...
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Manager, Regulatory Affairs
3 weeks ago
Hyderabad, Telangana, India myGwork Full timeThis job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Job Description Manager, Regulatory Affairs - CMC The incumbent is expected to be knowledgeable in project management principles, manufacturing change control management and CMC...
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Manager, Regulatory Affairs
3 weeks ago
Hyderabad, Telangana, India myGwork Full timeThis job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Job DescriptionManager, Regulatory Affairs - CMCThe incumbent is expected to be knowledgeable in project management principles, manufacturing change control management and CMC...