Regulatory Affairs Specialist

6 days ago


Madurai, Tamil Nadu, India Aurolab Full time

Job Summary

Aurolab seeks a highly skilled Regulatory Affairs Specialist to lead our product compliance efforts. As a key member of our team, you will be responsible for ensuring our products meet regulatory standards and customer expectations.

About the Role

The ideal candidate will have a deep understanding of USFDA and MHRA regulations, as well as excellent organizational skills and the ability to work collaboratively across departments.

Key Responsibilities

  • Prepare, review, and submit regulatory documents for USFDA and MHRA approval, including New Drug Applications (NDA) and Marketing Authorization Applications (MAA)
  • Ensure all submissions are accurate, complete, and in compliance with regulatory requirements
  • Manage timelines and tracking of regulatory submissions and approvals
  • Develop and implement regulatory strategies to ensure timely ANDA submissions and approvals
  • Stay up-to-date with regulatory changes and updates from USFDA and MHRA

Requirements

  • Bachelor's degree in Pharmacy or related field
  • Minimum 7-10 years of experience in pharmaceutical or biotechnology industry
  • In-depth knowledge of USFDA and MHRA regulations and guidelines

What We Offer

We offer a competitive salary of $120,000 per year, commensurate with experience, plus benefits and opportunities for professional growth.



  • Madurai, Tamil Nadu, India Aurolab Full time

    Aurolab is seeking a highly skilled Regulatory Affairs Specialist to join our team in Quality Assurance. This critical role requires comprehensive knowledge of regulatory requirements, excellent organizational skills, and the ability to work collaboratively across departments to ensure compliance with all applicable regulations.The successful candidate will...


  • Madurai, Tamil Nadu, India Aurolab Full time

    The Aurolab team is seeking an experienced Regulatory Affairs Specialist to lead the preparation, management, and coordination of regulatory submissions for USFDA and MHRA approvals for ophthalmology products manufactured at our plant in Madurai. This role requires comprehensive knowledge of regulatory requirements, excellent organizational skills, and the...


  • Madurai, Tamil Nadu, India Aurolab Full time

    Job OverviewAurolab seeks a Clinical Strategy Specialist to bridge medical expertise with strategic marketing, ensuring the effective translation of clinical research and scientific insights into compelling marketing strategies.Main Responsibilities:Clinical Research and Scientific InsightServe as the single point of contact (SPOC) for all clinical research...


  • Madurai, Tamil Nadu, India Aurolab Full time

    We are seeking a highly skilled Senior Taxation and Accounting Specialist to join our team at Aurolab in Madurai.The estimated salary for this position is ₹2,500,000 - ₹4,000,000 per annum, depending on experience.Key Responsibilities:* Ensure compliance with all applicable laws and regulations related to taxation and accounting* Lead the delivery of tax...


  • Madurai, Tamil Nadu, India Aurolab Full time

    Job DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at Aurolab. This role is responsible for ensuring the company's products meet all quality standards.The successful candidate will have a strong background in quality assurance and be proficient in implementing and maintaining an ISO 13485-compliant Quality Management...


  • Madurai, Tamil Nadu, India Live Connections Full time

    Join Live Connections as a Food TechnologistWe are seeking an experienced Food Technologist to join our team in Madurai, Tamil Nadu. As a key member of our food innovation team, you will be responsible for developing and ensuring the quality of food products.About the Role:Product Development: Develop new food products and processes that meet consumer needs,...


  • Madurai, India Aurolab Full time

    KEY RESPONSIBILITIES:Regulatory Affairs:·Build the technical files and drive risk management.·Understand parts, processes and performance.·Implement engineering change management.·Perform regular IQA.·Work closely with all cross-functional team members.·Review design documents & participate in periodic design reviews.·A weekly operating mechanism on...


  • madurai, India Aurolab Full time

    KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...


  • madurai, India Aurolab Full time

    KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...


  • Madurai, India Aurolab Full time

    KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...


  • Madurai, India Aurolab Full time

    KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly...


  • Madurai, India Aurolab Full time

    KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...


  • Madurai Palace, India Aurolab Full time

    KEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...


  • Madurai, India Aurolab Full time

    The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...


  • madurai, India Aurolab Full time

    The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...


  • Madurai, India Aurolab Full time

    The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...


  • Madurai, India Aurolab Full time

    The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...


  • madurai, India Aurolab Full time

    The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...


  • madurai, India Aurolab Full time

    The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...


  • Madurai, India Aurolab Full time

    The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...


  • Madurai, India Aurolab Full time

    The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...


  • Madurai, India Aurolab Full time

    The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements,...


  • Madurai, India Dream Jobs Global Full time

    Key Responsibilities for the Role:A Talent Acquisition specialist will typically be responsible for the following:Understanding Client Requirements: Engaging with clients to clearly understand their hiring needs, organizational culture, and job descriptions.Sourcing Candidates: Using various channels (job boards, , industry networks, etc.) to identify and...


  • Madurai, India CyberAssure Services (P) Ltd. Full time

    CyberAssure(www.cyberassure.one) is looking for a Privacy Operations Specialist to work across India / US hours. Key Responsibility Areas• Data discovery management and Consent management.• Data Subject Rights (DSR) management.• Overall Privacy Operations Management using Securiti.ai as a platform.• Working with various stakeholders w.r.t privacy...