
Manager-regulatory & Business Continuity - Us Market
3 days ago
Job Title Manager 2 1 RBC Business Unit Sun Global Operations Job Grade G11A 10 Location Gurgaon 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 Key responsibilities Regulatory submission of new products variations response to queries Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals Area Of Responsibility New submissions Review prepare CMC Chemistry Manufacturing and Controls dossiers for fresh submissions Review documents Development report scale up report specification stability protocol analytical validation etc Before initiation of Exhibit batches for adequacy Approval Review prepare response to deficiency enabling approval of products filed to regulatory agency Lifecycle management for drug formulations Prepare and review variation Annual notification and labelling approval for US and OAM Review of change control and file variation as per country requirement Regulatory compliance eCTD compilation Ensure reposition of comprehensive product information into central repository Review regulatory filing impact of variations change controls etc Travel Estimate 20 Job Requirements Educational Qualification M Sc B Pharm M Pharm Experience Tenure 8 to 12 years Your Success Matters to Us At Sun Pharma your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth Join us at Sun Pharma where every day is an opportunity to grow collaborate and make a lasting impact Let s create a brighter future together Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees as assigned to this job Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent s
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Manager - Regulatory Affair
4 weeks ago
Gurgaon, Haryana, India Sun Pharmaceutical Industries Full timeJOB DESCRIPTION Position Manager Senior Manager Job Location Gurgaon Education M Pharm Department Global Regulatory Affairs Job Responsibilities Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets...
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Manager/sr. Manager-regulatory Affairs
3 weeks ago
Gurgaon, Haryana, India Lifelancer Full timeJob Title Manager Sr Manager-Regulatory AffairsJob Location Gurugram Haryana IndiaJob Location Type On-siteJob Contract Type Full-timeJob Seniority Level Mid-Senior levelAt Lilly we unite caring with discovery to make life better for people around the world We are a global healthcare leader headquartered in Indianapolis Indiana Our employees...
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Business Regulatory Specialist
5 days ago
Gurgaon, Haryana, India beBeeRisk Full time ₹ 20,00,000 - ₹ 25,00,000Compliance ManagerThe Compliance Manager will oversee the implementation of regulatory requirements and ensure adherence across all functions.Key Responsibilities:Regulatory Implementation: Identify new laws and regulations applicable to the organization and implement them effectively.Review and Approval: Review products and documents to ensure they meet...
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Assistant Manager- Regulatory affairs
2 days ago
Gurgaon, Haryana, India Johnson & Johnson Innovative Medicine Full time US$ 90,000 - US$ 1,20,000 per yearAt 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...
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Regulatory Operations Publishing
3 days ago
Gurgaon, Haryana, India Reckitt Benckiser Full timeWe are Reckitt Home to the world s best loved and trusted hygiene health and nutrition brands Our purpose defines why we exist to protect heal and nurture in the relentless pursuit of a cleaner healthier world We are a global team united by this purpose Join us in our fight to make access to the highest quality hygiene wellness and nourishment a...
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Senior Regulatory Compliance Specialist
3 days ago
Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 20,27,617 - ₹ 34,88,193Job Title: Manager Regulatory and Business ContinuityAbout the Role:Oversee regulatory submissions for new products and variations.Lifecycle management involves preparing quality dossiers for timely approvals in US and OAM regions.Review and prepare CMC, Chemistry, Manufacturing, and Controls dossiers for fresh submissions.Maintain regulatory compliance by...
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Global Regulatory Operations Specialist
3 days ago
Gurgaon, Haryana, India beBeeRegulatory Full time US$ 6,00,000 - US$ 10,00,000Regulatory Executive RoleWe are seeking a skilled Regulatory Executive to drive our business forward by fostering a supportive community and promoting continuous progress.Key Responsibilities:Assume key roles in specialty programs, focusing on NCE BLA initiatives.Manage regulatory operations activities, including CTA applications globally.Collaborate with...
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Deputy Manager Regulatory Affairs
2 weeks ago
Gurgaon, Haryana, India Haleon Full timeJob Description- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.- Continuously looking for opportunities to learn, build skills and share learning.- Sustaining energy and well-being-...
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Gurgaon, Haryana, India Sun Pharmaceutical Industries Full timeJob Title Executive Business Unit Global Clinical Operation Job Grade G12A Location Gurgaon Mumbai 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...
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Manager Channel Marketing
3 days ago
Gurgaon, Haryana, India Mancraft Consulting Full timePrimary Role Description The Channel Marketing Manager is responsible for conceptualizing and executing marketing initiatives that directly enable sales and distribution teams while ensuring compliance with IRDAI regulations The role demands strong execution expertise creative development oversight and cross-functional stakeholder management to deliver...