Regulatory Affairs Specialist

3 weeks ago

Hyderabad, Telangana, India TeizoSoft Private Limited Full time
About the Job

The Regulatory Affairs Manager will play a crucial role in ensuring compliance with global regulations and policies for TeizoSoft Private Limited. This position requires a strong understanding of regulations and policies issued by India, US FDA, and EU, as well as the ability to interpret international regulatory requirements.


Key Responsibilities
  • Collaborate with cross-functional teams to ensure regulatory requirements are met throughout the product development lifecycle.
  • Develop and implement regulatory strategies for new or modified products, ensuring compliance with applicable regulations and policies.
  • Prepare, review, and file premarket documents for global registrations, as well as support marketing authorizations for assigned projects.
  • Represent Regulatory Affairs as a team member of product development projects from Concept through Commercialization, ensuring regulatory compliance and strategy alignment.
  • Review preclinical and clinical protocols and associated reports to be used in submissions for assigned projects, ensuring accuracy and compliance.
  • Monitor and provide information on the impact of changes in the regulatory environment, ensuring timely updates and compliance adjustments.
  • Communicate with regulatory agencies and/or notify bodies on administrative and routine matters, ensuring prompt and accurate responses.
  • Document, consolidate, and maintain oral and written communication with health authorities, ensuring accurate and compliant records.

Requirements
  • Minimum 7+ years of experience in a Regulatory Affairs role within the medical device or pharmaceutical industry.
  • Strong understanding of regulations and policies issued by India, US FDA, and EU, with ability to interpret international regulatory requirements.
  • Excellent written, organizational, and communication skills, with a flexible and team-oriented attitude.
  • Strong attention to detail and ability to handle multiple tasks, with good planning and pressure handling skills.
  • Good English language skills, including reading, writing, and speaking.

  • Regulatory Affairs Specialist

    1 month ago

    Hyderabad, Telangana, India Medtronic Full time

    Job Title: Regulatory Affairs SpecialistMedtronic is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Global Operating Unit, you will be responsible for ensuring compliance with regulatory requirements and ensuring the successful launch of our medical devices.Key Responsibilities:Prepare, review, and submit...

  • Regulatory Affairs Professional

    4 weeks ago

    Hyderabad, Telangana, India Medtronic Full time

    **Regulatory Affairs Role at Medtronic**About the JobWe are seeking a skilled Regulatory Affairs Specialist to support our Global Operating Unit Regulatory Affairs function. As the local representative, you will ensure that all requirements are met and support the needs of the MEIC with regulatory support for research and development activities.Key...

  • Regulatory Affairs Specialist

    3 weeks ago

    Hyderabad, Telangana, India Lifelancer Full time

    About the JobWe are seeking a highly skilled Senior Regulatory Affairs Specialist- Q&R to join our team at Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma, and IT. As a key member of our regulatory affairs function, you will play a critical role in ensuring compliance with global regulations and maintaining the highest standards of...

  • Regulatory Affairs Specialist

    3 weeks ago

    Hyderabad, Telangana, India Eastman Full time

    About the Role:Eastman is seeking a Regulatory Affairs Professional to join our team to help resolve difficult regulatory challenges and initiatives for our product portfolio. This role will focus on the REACH and CLP regulation in the European Union, as well as other similar REACH legislation in Turkey, China & Korea, etc.Key Responsibilities:Develop and...

  • Regulatory Affairs Specialist, Compliance and Governance

    4 weeks ago

    Hyderabad, Telangana, India Imaging Endpoints Full time

    Job Title: Manager, Compliance and Regulatory AffairsImaging Endpoints is a leading Imaging Technology and Imaging Clinical Research Organization (iCRO) passionately focused on our vision to Connect Imaging to the CureTM. We are seeking a seasoned Manager, Compliance and Regulatory Affairs to join our team and contribute to our mission to customize each...

  • Regulatory Affairs Specialist: Driving Compliance and Excellence

    2 weeks ago

    Hyderabad, Telangana, India Medtronic Full time

    At Medtronic, we're shaping the future of healthcare through innovative medical technology. As a Regulatory Affairs Specialist, you'll play a critical role in ensuring our products meet regulatory requirements and exceed customer expectations. Job OverviewWe're seeking an experienced Regulatory Affairs Specialist to join our team. In this role, you'll be...

  • Regulatory Affairs Specialist

    5 days ago

    Hyderabad, Telangana, India Parexel Full time

    Job DescriptionWe are seeking a highly experienced Regulatory Affairs Specialist to join our team at Parexel.About the Role:Lead and/or contribute to the planning, preparation, authoring, and delivery of regulatory maintenance submissions from a global and/or regional perspective.Manage (authoring and review) biologics/biosimilar/vaccine investigational...

  • Regulatory Affairs Manager

    1 month ago

    Hyderabad, Telangana, India Imaging Endpoints Full time

    Job Title: Regulatory Affairs ManagerImaging Endpoints is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Compliance and Regulatory Affairs department, you will be responsible for ensuring our company's compliance with regulatory requirements and industry standards.The ideal candidate will have a strong background...

  • Compliance Specialist

    4 days ago

    Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full time

    About the RoleWe are seeking a highly skilled Compliance Specialist to join our Global Regulatory Affairs team at Dr. Reddy's Laboratories Limited.Job SummaryThe successful candidate will be responsible for providing legal support by drafting and negotiating contracts, advising on marketing activities, and supporting the commercial team in strategic...

  • Regulatory Affairs Specialist in Biologics

    4 weeks ago

    Hyderabad, Telangana, India Parexel Full time

    Parexel Seeks Experienced Regulatory Affairs ProfessionalJob SummaryWe are seeking a highly skilled and experienced Senior Regulatory Affairs Associate-Biologics to join our team. As a key member of our regulatory affairs team, you will be responsible for handling pre and post-approval life cycle management of drug products, including biologics, in various...

  • Regulatory Affairs Manager

    4 weeks ago

    Hyderabad, Telangana, India Imaging Endpoints Full time

    Job DescriptionImaging Endpoints is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Compliance and Regulatory Affairs department, you will be responsible for assisting the Compliance and Regulatory Affairs Management in executing day-to-day tasks associated with managing, maintaining, and continually improving...

  • Regulatory Affairs Specialist

    5 days ago

    Hyderabad, Telangana, India Parexel Full time

    Parexel seeks a highly skilled Regulatory Affairs Specialist to join our team in this exciting role. With a focus on biologics, you will be responsible for handling pre and post-approval life cycle management of drug products.About the RoleIn this challenging and rewarding position, you will have the opportunity to utilize your knowledge of regulatory...

  • Regulatory Affairs Professional

    4 weeks ago

    Hyderabad, Telangana, India TeizoSoft Private Limited Full time

    About the JobJob SummaryTeizoSoft Private Limited seeks a skilled Regulatory Affairs Professional to support the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met. The ideal candidate will have 7+ years of experience in medical device and/or pharmaceutical industry and a strong understanding of...

  • Regulatory Affairs Specialist

    1 month ago

    Hyderabad, Telangana, India Parexel Full time

    Regulatory Affairs ConsultantAt Parexel, we're driven by a shared passion for delivering exceptional results. When our values align, there's no limit to what we can achieve.Key Responsibilities:Lead and/or contribute to the planning, preparation, and delivery of regulatory maintenance submissions from a global and/or regional perspective.Develop and execute...

  • Regulatory Affairs Expert for Medical Devices

    2 weeks ago

    Hyderabad, Telangana, India Lifelancer Full time

    Job OverviewWe are seeking a skilled Regulatory Affairs Specialist to join our team in Hyderabad, India. This role will be responsible for ensuring compliance with Indian and international regulations, collaborating with cross-functional teams, and supporting the development of medical devices.

  • Regulatory Affairs Expert with US Filing Experience

    13 hours ago

    Hyderabad, Telangana, India Eugia Pharma Specialities Ltd Full time

    About the Role">We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Eugia Pharma Specialities Ltd. This is a fantastic opportunity to work in a dynamic environment and contribute to the success of our organization.Key Responsibilities">The successful candidate will be responsible for planning, reviewing and submitting...

  • Regulatory Affairs Professional

    2 weeks ago

    Hyderabad, Telangana, India Lifelancer Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer. As a key member of our global regulatory affairs function, you will be responsible for ensuring compliance with international regulations and policies.Job DescriptionIn this role, you will work closely with cross-functional teams to support the...

  • Director, Regulatory Affairs Lead

    3 weeks ago

    Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Job SummarySeeking a seasoned Regulatory Affairs Leader to oversee the GSRD team in Hyderabad, ensuring seamless regulatory documentation processes and compliance with global standards. About the RoleThis is a unique opportunity to leverage your leadership skills, scientific expertise, and passion for regulatory affairs to drive business growth and...

  • Regulatory Affairs Associate

    1 month ago

    Hyderabad, Telangana, India Makro Full time

    Job SummaryWe are seeking a detail-oriented and proactive Associate Regulatory Affairs Publishing professional with 13 years of experience in regulatory submissions across global markets, including the US, UK, EU, and ROW. The ideal candidate will have a background in Life Sciences and possess hands-on experience with eCTD/aCTD submissions.Key...

  • Regulatory Affairs Professional

    2 weeks ago

    Hyderabad, Telangana, India Lifelancer Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma and IT. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with regulatory requirements for medical devices and pharmaceuticals.Job SummaryThe...