Current jobs related to Regulatory Affairs Specialist - Hyderabad, Telangana - Gamut HR Solutions

  • Regulatory Affairs Specialist

    2 weeks ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

    Job Title: Regulatory Affairs SpecialistAbout This RoleWe are seeking a detail-oriented professional to support end-to-end submissions for global markets, focusing on regulatory affairs - CMC (Chemical, Manufacturing and Controls) aspects.Key ResponsibilitiesPreparing Variation documentsEvaluating post-approval CMC changes in compliance with global...

  • Regulatory Affairs Specialist

    2 weeks ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

    Job Title:Regulatory Affairs Specialist - CMCJob Description:This position involves supporting submissions to regulatory authorities and managing the lifecycle of products. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Prepare, review, and compile high-quality regulatory submissions in electronic format,...

  • Regulatory Affairs Specialist

    2 weeks ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to support end-to-end submissions for global markets.The ideal candidate will possess expertise in Lifecycle Management, Veeva Vault RIM, and complex Initial and Variation submissions.Key ResponsibilitiesPrepare variation documents and/or evaluate post-approval CMC...

  • Regulatory Affairs Specialist

    1 week ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 4,00,000 - ₹ 8,00,000

    We're seeking a highly skilled Regulatory Affairs Specialist to join our team. This role combines domain expertise with product leadership, making you the bridge between industry workflows and cutting-edge AI solutions.Key Responsibilities:Provide subject matter expertise in Life Sciences/Pharma/Biotech/MedTech processes, regulations, and workflowsDevelop...

  • US Regulatory Affairs Professional

    2 weeks ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,20,00,000 - ₹ 1,50,00,000

    Regulatory Affairs Specialist OpportunityWe are seeking a highly skilled Regulatory Affairs professional to support our team in the US market.Key Responsibilities:Prepare and review regulatory submissions, including ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, and PADER in eCTD format.Maintain compliance with US FDA and ICH...

  • Regulatory Affairs Specialist

    1 week ago

    Hyderabad, Telangana, India Medtronic Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeRegulatory Affairs Specialist In this exciting role as a Regulatory Affair Specialist, you will...

  • Regulatory Affairs Coordinator

    2 weeks ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 6,00,000 - ₹ 10,00,000

    Job SummarySeeking a highly skilled Regulatory Affairs Specialist to prepare, review, and maintain regulatory documents ensuring compliance with international guidelines and country-specific requirements.Key ResponsibilitiesScreen and analyze documents received for product registration requests as per country-specific guidelines.Prepare, compile, and review...

  • Regulatory Affairs Professional for EU Compliance

    2 weeks ago

    Hyderabad, Telangana, India beBeeRegulatoryAffairs Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance with EU regulations. This role is pivotal in managing activities related to new application submissions through DCP, MRP, NP.This position requires excellent communication skills, both written and...

  • Unlock Healthcare Opportunities as a Regulatory Affairs Specialist

    2 weeks ago

    Hyderabad, Telangana, India beBeeregulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job Title:Regulatory Affairs SpecialistWe are seeking an experienced Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals in Europe.This role is pivotal in managing activities pertaining to new application submissions for Europe through DCP, MRP, NP.Key...

  • Regulatory Affairs Specialist

    2 weeks ago

    Hyderabad, Telangana, India beBeeCompliance Full time ₹ 1,80,00,000 - ₹ 2,50,00,000

    Job Title:Regulatory Affairs Specialist - CMC StrategyJob Summary:We are seeking a skilled professional to develop and execute CMC regulatory strategies for assigned products, ensuring global compliance.Key Responsibilities:Develop and execute comprehensive CMC regulatory strategies for assigned products across the product lifecycle.Lead the development,...

Regulatory Affairs Specialist

2 weeks ago

Hyderabad, Telangana, India Gamut HR Solutions Full time ₹ 5,00,000 - ₹ 10,00,000 per year

Company Overview

Gamut HR Solutions is dedicated to helping individuals find the right job opportunities effectively and efficiently. With a small yet dynamic team located in Hyderabad, we strive to connect talented professionals with companies in need of their expertise. Visit our website at to learn more about how we can assist in your career advancement.

Job Overview

We are seeking a dedicated Regulatory Affairs Specialist - Pharma to join our team in Hyderabad. This is a full-time, junior-level position designed for candidates with 1 to 3 years of experience. The chosen candidate will be responsible for a variety of regulatory procedures, ensuring compliance and managing strategic regulatory projects within the pharmaceutical sector.

Qualifications and Skills

  • Proficient in FDA regulatory submissions, crucial for the timely approval of products (Mandatory skill).
  • Skilled in risk management processes, necessary to identify, assess, and prioritize regulatory risks (Mandatory skill).
  • Adept at regulatory strategy development to efficiently navigate and comply with complex regulations (Mandatory skill).
  • Solid understanding of EU MDR compliance to ensure product safety and efficacy.
  • Experience with quality management systems, enabling efficient organization and processes for regulatory compliance.
  • Knowledge of ISO 13485 standards for designing and manufacturing medical devices.
  • Competency in labeling and documentation review to ensure accuracy and regulatory compliance.
  • Experience in product lifecycle management to oversee the entire regulatory process from development to post-market.

Roles and Responsibilities

  • Preparing and submitting regulatory documents to ensure compliance with regional and international regulatory requirements.
  • Collaborating with cross-functional teams to support regulatory strategies and submissions.
  • Conducting risk assessments and implementing risk mitigation strategies.
  • Maintaining up-to-date knowledge of regulatory legislation, guidelines, and standards.
  • Reviewing and approving labeling, promotional, and support materials.
  • Managing timelines and delivering high-quality regulatory submissions within set deadlines.
  • Providing regulatory input for new product development and design changes.
  • Participating in regulatory inspections and audits as required.