Global Regulatory Affairs Consultant

2 months ago


India Apsida Life Science Full time

Apsida Life Science has partnered with a leading Pharmaceutical company looking for a Global Regulatory Affairs Consultant.


The Global Regulatory Affairs Consultant will lead global regulatory strategies for marketing authorization submissions across emerging markets. The role involves working with submissions managers and regional teams to ensure timely, high-quality submissions, while managing risks and maintaining regulatory compliance.


Duties:


  • Develop Global Regulatory Strategies: Lead global strategies for simultaneous submissions, including innovative and accelerated pathways.


  • Identify and mitigate risks to protect business interests and prevent delays.


  • Submission Planning: Collaborate on detailed plans for individual country filings, including approvals and regulator meetings.


  • Lead Global Filing Teams: Coordinate teams to update core documentation and generate country-specific data for submissions.


  • Dossier Adaptation: Tailor core dossiers for country-specific requirements and finalise documents.


  • Compliance & Systems: Manage regulatory submissions in systems like Veeva Vault, ensuring alignment with internal policies..


  • Guide teams in preparing for pre-submission and review meetings with regulators.


  • Innovate Regulatory Processes: Propose innovations to expedite regulatory approvals.


  • Collaboration & Communication: Work closely with local teams and report key issues to senior management



  • india Radiant Systems Inc Full time

    SUMMARY OF POSITION: The Regulatory & Technical Data Migration Specialist supports Global Regulatory Affairs through the migration of Regulatory &Technical Data from EtQ L&R to EtQ RIMS, as part of the Regulatory Affairs RIMS implementation project. The successful candidate will possess the ability to evaluate and collaborate to determine the best path to...


  • India Radiant Systems Inc Full time

    SUMMARY OF POSITION:The Regulatory & Technical Data Migration Specialist supports Global Regulatory Affairs through the migration of Regulatory &Technical Data from EtQ L&R to EtQ RIMS, as part of the Regulatory Affairs RIMS implementation project. The successful candidate will possess the ability to evaluate and collaborate to determine the best path to...


  • india Radiant Systems Inc Full time

    SUMMARY OF POSITION:The Regulatory & Technical Data Migration Specialist supports Global Regulatory Affairs through the migration of Regulatory &Technical Data from EtQ L&R to EtQ RIMS, as part of the Regulatory Affairs RIMS implementation project. The successful candidate will possess the ability to evaluate and collaborate to determine the best path to...


  • india QR678 Full time

    Senior Manager, Medical Affairs, QR678 Location: ( Bandra Kurla Complex, Mumbai ) Job Timing: 10:00 AM to 7:00 PM Salary Range: ₹9 - 15 LPA About the Company: QR678 is a leading name in the field of advanced hair restoration treatments, recognized for its innovative approach in addressing hair loss and related conditions. Developed by, QR678 neo is a...


  • india Mirchandanis Career Placements India Pvt. Ltd. Full time

    Job Summary: We are seeking an experienced and dynamic Corporate Relations Manager to lead our government affairs and corporate relations efforts. The ideal candidate will be responsible for developing and maintaining relationships with policymakers, trade associations, and critical stakeholders to support and further our business goals. This role involves...


  • india Biocon Full time

    Role - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 10 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...


  • india Biocon Biologics Full time

    At BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other...

  • Consultant

    2 days ago


    India Conscious Humanity Network Foundation - Global Non-profit Aggregator and Communities Full time

    We need Part-Time Consultants for Conscious Humanity Network Foundation, a Global Section 8 Non-profit registered under the Ministry of Corporate Affairs of India in October 2023. Linkedin Page - Website - Responsibilities Work dynamically as per the needs of the Non-profit which is working like a Global Social Startup. Be involved in work as...

  • Consultant

    2 days ago


    india Conscious Humanity Network Foundation - Global Non-profit Aggregator and Communities Full time

    We need Part-Time Consultants for Conscious Humanity Network Foundation, a Global Section 8 Non-profit registered under the Ministry of Corporate Affairs of India in October 2023. Linkedin Page - Website - Responsibilities Work dynamically as per the needs of the Non-profit which is working like a Global Social Startup. Be involved in work as per...


  • India Ashoka University Full time

    **Reports to: Vice Chancellor** **Location: Sonipat, NCR** **Experience (in years): Minimum 18 years** **Nature of work: Full Time** **About Ashoka X** **About Ashoka University**: 10 years ago, we embarked on a journey to establish a world-class, multi-disciplinary, liberal arts and sciences university in India. Built on the finest global best...


  • India ProductLife Group Full time

    **Specific activities and responsibilities**: Australia / South Africa / Brazil and GCC experience **Required education**: Degree in relevant life science discipline **Required experience**: 2-4 years relevant experience for Australia / South Africa / Brazil and GCC experience **Required technical skills**: - Lifecycle maintenance experience - Providing...

  • Regulatory Manager

    1 month ago


    india Juniper Green Energy Full time

    About the Company:Juniper Green Energy is an independent renewable energy power producer and operator of solar, wind and hybrid power projects with significant experience in conceptualizing, building, and developing renewable energy assets. The company is part of the AT Group which has an asset portfolio worth of approximately US$2.5 billion with global...


  • india Choice Logistics Full time

    POSITION OVERVIEW: Provide guidance on import, export, and global trade compliance matters. Work with the VP, Corporate Counsel and Regulatory Affairs to ensure the expeditious flow of goods across country borders to support supply chain requirements. The successful candidate will have a strong operational background with a focus on maintaining a compliant...


  • India Choice Logistics Full time

    POSITION OVERVIEW: Provide guidance on import, export, and global trade compliance matters. Work with the VP, Corporate Counsel and Regulatory Affairs to ensure the expeditious flow of goods across country borders to support supply chain requirements. The successful candidate will have a strong operational background with a focus on maintaining a compliant...


  • India Sunrise Systems, Inc. Full time

    12 month contractWork hours - 04.30 pm to 08.30 PM IST (4 Hours - Part Time)Qualifications: A Bachelor's degree in Sciences, Engineering, or equivalent technical degree.Strong IT literacy, aptitude for systems thinking, and demonstrated proficiency working within a regulatory, technical, and/or quality database.Proven ability to communicate in written and...


  • india Sunrise Systems, Inc. Full time

    12 month contractWork hours - 04.30 pm to 08.30 PM IST (4 Hours - Part Time)Qualifications: A Bachelor's degree in Sciences, Engineering, or equivalent technical degree.Strong IT literacy, aptitude for systems thinking, and demonstrated proficiency working within a regulatory, technical, and/or quality database.Proven ability to communicate in written and...


  • india Sunrise Systems, Inc. Full time

    12 month contract Work hours - 04.30 pm to 08.30 PM IST (4 Hours - Part Time) Qualifications: A Bachelor's degree in Sciences, Engineering, or equivalent technical degree. Strong IT literacy, aptitude for systems thinking, and demonstrated proficiency working within a regulatory, technical, and/or quality database. Proven ability to communicate in...


  • India Sunrise Systems, Inc. Full time

    12 month contract Work hours - 04.30 pm to 08.30 PM IST (4 Hours - Part Time) Qualifications: A Bachelor's degree in Sciences, Engineering, or equivalent technical degree. Strong IT literacy, aptitude for systems thinking, and demonstrated proficiency working within a regulatory, technical, and/or quality database. Proven ability to communicate in...


  • India Choice Logistics Full time

    POSITION OVERVIEW: Provide guidance on import, export, and global trade compliance matters. Work with the VP, Corporate Counsel and Regulatory Affairs to ensure the expeditious flow of goods across country borders to support supply chain requirements. The successful candidate will have a strong operational background with a focus on maintaining a...


  • India Choice Logistics Full time

    POSITION OVERVIEW: Provide guidance on import, export, and global trade compliance matters. Work with the VP, Corporate Counsel and Regulatory Affairs to ensure the expeditious flow of goods across country borders to support supply chain requirements. The successful candidate will have a strong operational background with a focus on maintaining a compliant...