Regulatory Affairs Expertise Opportunity

3 weeks ago


Hyderabad, Telangana, India Parexel Full time

Parexel is committed to delivering excellence in drug development.

  • A minimum of 8 years' experience in handling life cycle management of approved drug products for ROW markets, including Tablets, Syrups, Ointments, and Nasal Sprays.
  • Working knowledge of ROW regulatory guidelines, encompassing post-approval requirements.
  • Familiarity with ASEAN markets' regulatory legislations would be an added advantage.
  • Leverage expertise in planning, preparing, and delivering regulatory maintenance submissions from a global and/or regional perspective.
  • Lead or contribute to minor labeling variations & safety labeling variations across ROW countries as per business needs.
  • Experience in handling CMC & labelling related health authority queries.
  • Collaborate closely with cross-functional members with aligned responsibilities and provide status updates to designated stakeholders.
  • Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable.
  • Experience on Artwork Management Tools like Vista link would be an added advantage.

Key Responsibilities:

  • Provide subject matter expertise in regulatory affairs.
  • Develop and implement regulatory strategies.
  • Liaise with cross-functional teams.

We Offer:

  • An estimated salary of $120,000 - $150,000 annually.
  • A dynamic work environment.
  • Opportunities for growth and professional development.


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • Hyderabad, Telangana, India TeizoSoft Private Limited Full time

    About the JobThe 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...


  • 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...


  • 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...


  • Hyderabad, Telangana, India Imaging Endpoints Full time

    Regulatory Affairs ManagerImaging Endpoints is an Imaging Technology and Imaging Clinical Research Organization (iCRO) that is passionately focused on its vision to Connect Imaging to the CureTM. The company works every day to advance imaging science, technology, and services to bring curative technologies to humankind. We are seeking a talented Regulatory...


  • 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...


  • 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...


  • Hyderabad, Telangana, India Lifelancer Full time

    Job TitleRegulatory Affairs Expert - Enhanced Regulatory ComplianceAbout the RoleThis exciting opportunity is part of a globally inclusive and diverse company, Eastman Chemical Company. As a Regulatory Affairs Expert, you will be responsible for resolving complex regulatory challenges and initiatives for Eastman's product portfolio.Your primary focus will be...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...