Regulatory Cmc
3 days ago
This position will support and manage the regulatory activities associated with the Chemistry Manufacturing and Controls for New Drug Applications across globe Regulatory activities focus on filing activities query responses post approval changes as suggested across globe Person will be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that timely and high quality regulatory submissions are made Understanding global regulatory requirements particularly for US EU Japan China and rest of markets and sharing additional data generation gap assessments with CFT Closely work with consultants partners and local regulatory colleagues to understand regional requirements Preparation of Agency consultation packages briefing book and required presentations and engage with Agency for consultations Provide CMC support for other branded projects as needed Additional duties include coordination with our global manufacturing sites integration of regulatory strategy with those sites and communication to senior management Responsible for preparation of IND and IMPD documents Providing consistent support to commercial and clinical teams
-
Global Regulatory Lead
2 days ago
Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000This role focuses on overseeing and managing global regulatory activities for Chemistry Manufacturing and Controls (CMC) within New Drug Applications.Key Responsibilities:Maintain the filing process, query responses, and post-approval changes globally.Align the established regulatory strategy with Health Authority requirements from a global...
-
Regulatory Compliance Specialist
6 days ago
Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 40,00,000 - ₹ 50,00,000Job Overview">The role of a Regulatory Compliance Manager involves ensuring adherence to regulatory requirements for new products and variations in the US market. This includes reviewing and preparing CMC dossiers, stability protocols, and analytical validation reports.">Key Responsibilities">Review and prepare CMC dossiers for fresh submissionsReview...
-
Regulatory Affairs Lead
4 days ago
Gurgaon, Haryana, India beBeeRegulatoryAffairsManager Full time ₹ 1,04,000 - ₹ 1,30,878Job Title: Senior Regulatory Affairs ManagerThe role of the Senior Regulatory Affairs Manager is to serve as a high-level expert in regulatory affairs, overseeing the development and implementation of regulatory strategies for products. This includes interacting with regulatory agencies to expedite approval, serving as a liaison throughout the product...
-
Expert Regulatory Affairs Leader
5 days ago
Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 30,00,000Senior Regulatory Affairs Manager RoleThis is a key leadership position that requires strong expertise in Regulatory Affairs.Job Responsibilities:Lead the development of product registration submissions, progress reports, and periodic experience reports.Engage with regulatory agencies to expedite approval of pending registrations and ensure compliance with...
-
Regulatory Intelligence Lead
2 days ago
Gurgaon, Haryana, India Sun Pharmaceutical Industries Full timeSummary Under the leadership of the Senior Director Head Global Regulatory Intelligence and Policy GRIP partner with enterprise leadership to answer potentially sophisticated questions based on the ability to efficiently obtain analyze and summarize external information notably global precedents and or regulations to facilitate efficient drug...
-
Senior Regulatory Compliance Specialist
1 week 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...
-
Senior Regulatory Compliance Expert
6 days ago
Gurgaon, Haryana, India beBeeRegulatoryAffairs Full time ₹ 20,00,000 - ₹ 25,00,000Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to serve as an expert individual contributor within our organization. This role requires comprehensive knowledge of regulatory affairs, with the ability to manage and execute highly complex or specialized projects. The Specialist will apply advanced regulatory expertise, adapting...
-
Regulatory Consultant
2 days ago
Gurgaon, Haryana, India Syneos Health Full time ₹ 15,00,000 - ₹ 20,00,000 per yearDescriptionRegulatory Consultant (CMC- EU/Japan/China)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the...
-
Project Manager – Regulatory Affairs
3 days ago
Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time US$ 90,000 - US$ 1,20,000 per yearJob SummaryWe are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, ensuring timely and successful product registration, market authorization, and compliance with relevant regulatory requirements. The ideal candidate will have a deep understanding of global...
-
Gurgaon, Haryana, India Sun Pharmaceutical Industries Full timeJob 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...
