Manager Global Regulatory Affairs

17 hours ago

Bengaluru, Karnataka, India Biocon Biologics Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Job Summary:

Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.

Responsible for:


• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio


• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products


• Collaboration with partners to develop and execute global regulatory activities


• DMF preparations, review of changes and routine updates to Global Regulatory Agencies


• Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution


• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements


• Provide regulatory direction on global regulatory requirements to support product development


• Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle


• Support development and execution of clinical/non-clinical strategies


• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration


• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans


• With minimal supervision, participate in development of risk management and contingency planning


• Ensure and lead regulatory compliance for biosimilar products


• Participation in regulatory meetings with Health Authorities Regulatory Intelligence:


• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products


• Review and assess impact of regulatory decisions for competitive products
• Generate and communicate biosimilar intelligence Collaboration:


• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products


• Identify process needs to meet internal challenges


• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and Skills


• Comprehensive understanding of Regulatory activities


• Regulatory experience with product filings


• Team skills, especially in working with internal and external partners


• Familiarity with project management requirements


• Ability to understand and communicate scientific CMC information


• Anticipate and prevent potential issues


• Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission

Education

Doctorate degree OR Master's degre

  • Senior Manager, Global Regulatory Affairs

    1 week ago

    Bengaluru, Karnataka, India 50skills Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    We 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...

  • Business Development Executive

    5 days ago

    Bengaluru, Karnataka, India Silmed Scientific - Global Regulatory Affairs Partner Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Company DescriptionSilmed Scientific is a global leader in regulatory affairs, specializing in delivering comprehensive end-to-end regulatory solutions for pharmaceuticals, medical devices, and biosimilars. With expertise in regulatory strategy and successful drug development, the company supports approvals across global markets including Europe, the US,...

  • Regulatory Affairs Executive

    3 days ago

    Bengaluru, Karnataka, India Kerala Ayurveda Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Are you passionate about ensuring regulatory excellence in the world of Ayurveda and nutraceuticals?Kerala Ayurveda Limited is looking for a Regulatory Affairs Executive with 4-6 years of experience to join our growing team in Bangalore. This is a great opportunity to work at the intersection of traditional Ayurvedic wisdom and global compliance standards,...

  • Manager - Regulatory Affairs

    14 hours ago

    Bengaluru, Karnataka, India Aarna HR Solutions Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company Description Greeting Aarna HR Solutions is a Human Resource Recruitment Company providing services to Various IT, ITES and Non- IT companies across India. Aarna Solutions strive towards hiring the best and the brightest talent in the industry. We hire individuals with a strong sense of pride in their performance, team spirit, and a desire to excel. ...

  • Head- Regulatory Affairs

    3 days ago

    Bengaluru, Karnataka, India Siemens Healthineers Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job ID473488Posted since13-Oct-2025OrganizationSiemens HealthineersField of workQuality ManagementCompanySiemens Healthcare Private LimitedExperience levelExperienced ProfessionalJob typeFull-timeWork modeOffice/Site onlyEmployment typePermanentLocation(s)Bangalore - Karnataka - IndiaThe Head of Regulatory Affairs will lead the regulatory function for...

  • Regulatory Affairs Manager- SME

    4 weeks ago

    Bengaluru, Karnataka, India, Karnataka Mount Talent Consulting Pvt Ltd. Full time

    Domain lead - SME - Safety and Regulatory - BA offshoreExpert in Pharma domain’s multiple functions especially Regulatory and SafetyWell versed with business functions and tools used by industryAble to create integrated solutions and able to address customer pain pointsAble to draw process flowsAct as Technical Product Owner for global regulatory systems...

  • Regulatory Affairs Manager

    23 hours ago

    Bengaluru, Karnataka, India Biocon Biologics Limited Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Key Responsibilities:Regulatory Strategy & Planning• Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries.• Ensure alignment with global regulatory strategy and business priorities.• Conduct regulatory risk assessment and provide mitigation strategies...

  • Regulatory Affairs

    14 hours ago

    Bengaluru, Karnataka, India Dozee Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Note- Candidates who can join immediately can apply Job Description -Regulatory Affairs- Intern Overview We are seeking a highly motivated and experienced person to join our team Responsibilities:Participate in the development of regulatory submission and approval strategy in multiple countries.Maintain awareness and understanding of new and existing...

  • Senior Regulatory Affairs Specialist

    2 days ago

    Bengaluru, Karnataka, India AliveCor Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    AliveCor 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...

  • Regulatory Affairs Data Analyst

    21 hours ago

    Bengaluru, Karnataka, India Resmed Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Job Description: Regulatory Affairs Data Analyst (GenAI Focus)About the RoleWe are seeking a Regulatory Affairs Data Analyst with a strong analytics background and a passion for emerging technologies to join our global Regulatory Affairs team. This role blends data analytics, enterprise document intelligence, and generative AI, with a focus on enhancing...