Regulatory Affairs Assistant

2 days ago

Hyderabad, Telangana, India Gamut HR Solutions Full time ₹ 5,00,000 - ₹ 12,00,000 per year

Company Overview

Gamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at

Job Overview

We are seeking a Mid-Level Regulatory Affairs Assistant to join our team full-time in Hyderabad. This role requires 4 to 6 years of experience in regulatory affairs, ideally in the healthcare or pharmaceutical sector. The candidate will play a vital part in navigating regulatory requirements and ensuring compliance for our projects.

Qualifications and Skills

  • Proficiency in clinical trial documentation, ensuring that all protocols, reports, and submissions are accurately completed (Mandatory skill).
  • Experience in regulatory submissions, including preparation, filing, and management for different regulatory bodies (Mandatory skill).
  • Ability in regulatory strategic planning to develop comprehensive plans for meeting regulatory requirements (Mandatory skill).
  • In-depth understanding of FDA regulations to ensure that all processes comply with necessary standards.
  • Knowledge of EU MDR compliance, ensuring adherence to European Medical Device Regulation standards.
  • Familiarity with GxP standards to assure the quality and integrity of processes and products.
  • Experience in quality management systems to oversee processes meeting both internal and external requirements.
  • Understanding of labeling requirements to ensure product labels meet regulatory standards.

Roles and Responsibilities

  • Assist in the preparation and submission of regulatory documents to appropriate regulatory bodies.
  • Coordinate with cross-functional teams to gather necessary documentation for regulatory submissions.
  • Monitor and track submissions and ensure all regulatory timelines are met.
  • Maintain up-to-date knowledge of regulatory requirements and changes in the regulatory landscape.
  • Provide support in the development of regulatory strategies and implementation plans.
  • Liaise with internal departments to ensure regulatory compliance is maintained across all projects.
  • Prepare and review technical documentation to ensure compliance with regulatory standards.
  • Support internal and external audits by gathering necessary documents and evidence.

  • Regulatory Affairs

    2 days ago

    Hyderabad, Telangana, India Clininfotech Full time ₹ 4,00,000 - ₹ 6,00,000 per year

    We are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad LocationThe ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Required Candidate profileB.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are...

  • Executive Regulatory Affairs

    1 week ago

    Hyderabad, Telangana, India Jodas Expoim Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Job Title: Regulatory Affairs ExecutiveDepartment: Regulatory AffairsLocation: HyderabadExperience: 1-5 YearsIndustry: Pharmaceuticals (Injectables / OSD)About Jodas ExpoimJodas Expoim is a fast-growing, global pharmaceutical company committed to delivering high-quality, affordable medicines. We focus on complex injectables and are driven by innovation,...

  • Senior Regulatory Affairs Specialist

    6 days ago

    Hyderabad, Telangana, India Dyaz Innovate Full time ₹ 8,00,000 - ₹ 24,00,000 per year

    Company DescriptionDyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment.Role DescriptionThis is a full-timeon-siterole for a Senior Regulatory...

  • Regulatory Affairs _ US Market

    2 weeks ago

    Hyderabad, Telangana, India BVR People Consulting Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    GreetingsWe are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre.Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes.Key Responsibilities:Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved...

  • Regulatory Affairs Specialist

    8 hours ago

    Hyderabad, Telangana, India Gamut HR Solutions Full time ₹ 1,20,000 - ₹ 3,60,000 per year

    Company OverviewGamut 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...

  • Clinical/Regulatory Affairs Professional

    7 days ago

    Hyderabad, Telangana, India PlebC Innovations Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    PlebC Innovations Pvt. Ltd. is looking for aClinical/Regulatory Affairs Specialistto join our growing team in Hyderabad.About the Role:You will be responsible for supporting clinical and regulatory operations, ensuring compliance with applicable guidelines, preparing documentation for regulatory submissions, and coordinating with authorities for approvals....

  • Regulatory Affairs Manager

    2 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and...

  • Head Regulatory Affairs

    2 days ago

    Hyderabad, Telangana, India Digvijaya Management Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Candidate should be M.Pharmacy with 18-20 years of experience in Regulatory Affairs department from a reputed formulations manufacturing Industry.Regulatory Strategy and Compliance:Develop and implement regulatory strategies for product formulations to ensure compliance with all applicable regulations and guidelines.Stay updated with changes in regulatory...

  • Regulatory Affairs

    7 days ago

    Hyderabad, Telangana, India Shilpa Medicare Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Role & responsibilitiesCMC and Labelling:Preparation of ANDAs in eCTD format for various type of formulationsReview of the technical documents such as Specifications, BMR, MFC,Able to work on All type of CTD section write-upsHands on experience on life cycle management activity (AR, CBE, CBE-30 and PAS)Through knowledge on ICH guidancesShould able to handle...

  • Regulatory Affairs Analyst

    5 hours ago

    Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Company Description Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait.We started in 1984 with a modest investment, 20...