Executive Regulatory Affairs

1 day ago

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

Job Title: Regulatory Affairs Executive

Department: Regulatory Affairs

Location: Hyderabad

Experience: 1-5 Years

Industry: Pharmaceuticals (Injectables / OSD)

About Jodas Expoim

Jodas 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, compliance, and excellence.

Key Responsibilities:

  • Prepare, compile, and review registration dossiers (CTD/eCTD formats) for product submissions to ROW/ CIS markets in compliance with local regulatory requirements.
  • Coordinate with cross-functional teams (Formulation, QA, QC, Production, and RA teams) to gather and verify technical documents for submission.
  • Manage lifecycle activities including variations, renewals, and responses to regulatory queries.
  • Track submission timelines and maintain up-to-date records of product registrations and regulatory statuses.
  • Evaluate country-specific regulatory guidelines and ensure that product dossiers meet those requirements.
  • Communicate with local agents, distributors, or regulatory consultants in ROW countries for submission planning and updates.
  • Assist in compiling GMP/WHO-related documents and site registrations as required.
  • Stay updated with global regulatory changes and proactively support compliance.
  • Participate in regulatory audits and inspections by supporting documentation and regulatory readiness.

Desired Candidate Profile:

  • B.Pharm / M.Pharm / M.Sc. in a relevant life science discipline.
  • 15 years of hands-on experience in regulatory affairs, preferably handling ROW market submissions.
  • Familiarity with CTD/eCTD structure and requirements.
  • Good understanding of ICH guidelines and global regulatory frameworks.
  • Strong verbal and written communication skills in English and Hindi.
  • Detail-oriented, proactive, and capable of working independently or as part of a team.
  • Proficient in MS Office (Word, Excel, PowerPoint).

Regards

Team Jodas Expoim PVT LTD

  • Regulatory Affairs Specialist

    2 weeks ago

    Hyderabad, Telangana, India Morulaa HealthTech Pvt. Ltd. Full time

    Company DescriptionMorulaa HealthTech Pvt. Ltd. was founded to assist in the commercialization of bio-science technologies and the growth of healthcare companies. Based in Ohio and collaborating with Cleveland Clinic, University Hospitals, and Case Western Reserve University, Morulaa specializes in the Registration of Medical Devices and Distributor...

  • Regulatory Affairs Manager

    5 days ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 1,20,000 - ₹ 2,40,000 per year

    Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a...

  • Regulatory Affairs Associate Director

    5 days ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Role description:Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this...

  • Regulatory Affairs Manager

    2 weeks ago

    Hyderabad, Telangana, India Evertogen Life Sciences Full time ₹ 80,00,000 - ₹ 1,50,00,000 per year

    We seek a seasoned Regulatory Affairs Head to lead and drive the global regulatory strategy for our formulation-based pharmaceutical products across Europe and Rest of World (ROW) markets at Evertogen Life Sciences. As the Regulatory Affairs Head, you will play a crucial role in overseeing all regulatory submissions, compliance management, and lifecycle...

  • Regulatory Affairs Manager

    5 days ago

    Hyderabad, Telangana, India Amgen Inc 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...

  • Regulatory Affairs Assistant

    2 weeks ago

    Hyderabad, Telangana, India Gamut HR Solutions Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company OverviewGamut 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 OverviewWe are seeking a Mid-Level Regulatory Affairs Assistant to join our team full-time in...

  • Regulatory Affairs Associate Director

    2 weeks ago

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

    Career CategoryRegulatoryJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years...

  • Regulatory Affairs- eCTD Specialist

    2 weeks ago

    Hyderabad, Telangana, India Nooha Asp Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Regulatory Affairs Hiring Profile eCTD SpecialistExperience Level: 3 to 6 YearsLocation: Work from office (Hyderabad)Skills & Qualifications:1.Education: Bachelor's or Masters degree in Life Sciences, Regulatory Affairs, or related field.2.Experience: 3 to 6 years of experience in regulatory affairs with a focus on eCTD submissions, preferably in the...

  • Regulatory Affairs Specialist

    2 weeks ago

    Hyderabad, Telangana, India Naukri Healthcare Jobs Full time ₹ 4,00,000 - ₹ 6,00,000 per year

    We are looking for a skilled Regulatory Affairs Specialist to join our team at Medifodil Smart Pharma Solutions, with 4-7 years of experience in the Pharmaceutical & Life Sciences industry.Roles and ResponsibilityDevelop and implement regulatory strategies to ensure compliance with relevant laws and regulations.Prepare and review regulatory submissions,...

  • Regulatory Affairs Intelligence Manager

    5 days ago

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

    The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director. This role often has a technology and data focus , managing the tools and information that drive the intelligence process.Key Responsibilities:Intelligence Gathering &...