Specialist-Regulatory Affairs CMC
4 hours ago
Primary Responsibilities:
- Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval.
- Responsible for writing CMC modules 2 & 3.
- Exposure to EU & CIS region in Regulatory filings
- Manage and coordinate product life cycle management.
- Ensure regulatory compliance with local regulatory requirements.
- Foster and maintain professional relationships with the health authorities.
- Provide regulatory support including timely registration of new product and line extensions to support new product launches, tender application, and whenever necessary.
- Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
- Promote regulatory intelligence in both local and regional initiatives.
- Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.
- Responsible for reviewing CMC modules.
- Execution of regulatory strategies (local and regional) in line with business plan.
- Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
- Ensure to adherence to timelines and quality set parameters.
- Review of Formulation, generation of ingredient list and Claims as per set standards.
Qualification
- Minimum B.S. Chemistry, Pharmacy or related scientific field
- Experience in CMC regulatory affairs for pharmaceutical products.
- Experience in Module 3, Module 2.3 and relevant Module 1 e-CTD documentation
-
Senior Specialist _ Regulatory CMC
2 weeks ago
Bengaluru, Karnataka, India Merck Specialities Pvt. Ltd. Full time ₹ 12,00,000 - ₹ 36,00,000 per yearYour Role: To provide end-to-end support for Annual Reports and Renewals for all products, e.g. planning of required activities, attend kick-off/jour-fixe meetings, contribute to DSP and ensure timely collection of respective requirements and deliverables Update and review CMC specific documentation, incl. coordination with countries to compile local CMC...
-
CMC Regulatory Project Manager
1 week ago
Bengaluru, Karnataka, India GSK Full time ₹ 60,000 - ₹ 1,20,000 per yearSite Name: UK – London – New Oxford Street, Bengaluru Luxor North Tower, Egypt - Cairo, Poznan Grunwaldzka, USA - North Carolina - Durham, WarsawPosted Date: Oct Are you a driven and innovative Regulatory Affairs professional looking to make a meaningful impact on the global supply of medicines? Join our Chemistry, Manufacturing and Controls (CMC)...
-
CMC Regulatory Project Manager
1 week ago
Bengaluru, Karnataka, India GSK Full time ₹ 80,000 - ₹ 1,20,000 per yearSite Name:UK – London – New Oxford Street, Bengaluru Luxor North Tower, Egypt - Cairo, Poznan Grunwaldzka, USA - North Carolina - Durham, WarsawPosted Date:Oct Are you a driven and innovative Regulatory Affairs professional looking to make a meaningful impact on the global supply of medicines?Join our Chemistry, Manufacturing and Controls (CMC)...
-
Senior Manager, Global Regulatory Affairs
7 days ago
Bengaluru, Karnataka, India 50skills Full time ₹ 20,00,000 - ₹ 25,00,000 per yearWe are looking for a Senior Manager to join our Global Regulatory Affairs team, specializing in Lifecycle Management (LCM) for Chemistry, Manufacturing, and Controls (CMC). CMC ensures that pharmaceutical products are consistently produced and meet quality standards during development and throughout their lifecycle.In this role, you will develop global...
-
CMC Regulatory Project Manager
2 weeks ago
Bengaluru, Karnataka, India GSK Full time ₹ 60,000 - ₹ 1,20,000 per yearNazwa biura: UK – London – New Oxford Street, Bengaluru Luxor North Tower, Egypt - Cairo, Poznan Grunwaldzka, USA - North Carolina - Durham, WarsawPosted Date: Oct Are you a driven and innovative Regulatory Affairs professional looking to make a meaningful impact on the global supply of medicines? Join our Chemistry, Manufacturing and Controls (CMC)...
-
Senior Regulatory Affairs Specialist
2 days ago
Bengaluru, Karnataka, India AliveCor Full time ₹ 12,00,000 - ₹ 24,00,000 per yearAliveCor seeks a Senior Regulatory Affairs Specialist to join this exciting start-up that is changing the face of mobile health. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing and...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India AliveCor Full time US$ 1,00,000 - US$ 1,50,000 per yearDescriptionAt AliveCor, we imagine a healthier world powered by access to personalized intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Philips Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob TitleRegulatory Affairs SpecialistJob DescriptionJob Title : Regulatory Affairs SpecialistJob Responsibilities:• Monitors global regulatory changes, interprets requirements, and integrates findings into regulatory strategies, ensuring timely communication with teams.• Implements regulatory strategies for international markets, collaborating with...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Philips Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob TitleRegulatory Affairs SpecialistJob DescriptionMinimum required Education: High School Diploma, Vocational Education / Bachelor's Degree in Business Administration, Communications, Quality Management, Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent. Minimum required Experience: Minimum 2 years of...
-
Regulatory Affairs Manager
2 weeks ago
Bengaluru, Karnataka, India Kumar Organic Products Full timeJob Title: Regulatory Affairs ManagerDepartment: Regulatory Affairs / Quality & ComplianceReporting to: Head Regulatory AffairsJob Purpose:To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing...