Regulatory Affairs- eCTD Specialist

5 days ago


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

Regulatory Affairs Hiring Profile eCTD Specialist

Experience Level: 3 to 6 Years

Location: 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 pharmaceutical or biotechnology industry.

Role Overview:

With 3 to 6 years of experience in regulatory affairs, this role requires expertise in eCTD submission software, strong knowledge of global regulatory standards, and the ability to troubleshoot and improve submission processes. The specialist will ensure compliance with evolving regulatory guidelines, provide support and training to teams, and collaborate with clients to meet submission requirements.

Technical Skills:

o Hands-on experience with eCTD submission software (e.g., Veeva Vault QMS, Lorenz DocuBridge, eCTDExpress etc.).

o Strong knowledge of global regulatory requirements (FDA, EMA, PMDA, etc.) and eCTD formatting standards.

o Familiarity with submission systems and document management processes.

Soft Skills:

  • Excellent attention to details and organizational skills.
  • Strong communication skills, both written and verbal.
  • Ability to work independently and collaboratively with clients.
  • Problem-solving skills and the ability to troubleshoot technical issues related to clients eCTD submissions.

Key Responsibilities:

  • Develop and manage our own eCTD software tool for the creation, validation, and submission of regulatory dossiers for all the regions.
  • Stay up to date with the latest regulatory guidelines, standards, and requirements related to eCTD submissions.
  • Continuously review and analyze regulatory trends and changes to ensure ongoing compliance and implementation of industrys best practices.
  • Conduct troubleshooting and resolve any issues related to eCTD submission formats and software functionality for our clients.
  • Provide training and support to Development Team on the use of eCTD tools and best practices.
  • Conduct quality checks on our eCTD tool and ensure they adhere to submission guidelines.
  • Assist in making our eCTD software more robust, user friendly and easy to use.
  • Keep up to date with new regulatory developments and technological advancements related to eCTD submissions and ensure team members are informed.
  • Collaborate with clients to ensure all their submission-related requirements are met for successful filings.


  • 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

    1 week 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...

  • Regulatory Affairs

    2 weeks 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...


  • 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...


  • Hyderabad, Telangana, India Revio Therapeutics Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Role DescriptionRevio Therapeutics is seeking a seasoned Regulatory Affairs Manager with 10–15 years of experience to oversee all regulatory activities across development and registration of our 505(b)(2)/Hybrid programs. This role requires deep understanding of US FDA regulations, guidances as well as for other regulated markets. The candidate should have...


  • Hyderabad, Telangana, India Makrocare Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Education: Bachelors Degree in Life Sciences or related fieldMarkets: US/UK/EU/ROW Job Summary:We are seeking a detail-oriented and proactive Associate - Regulatory Affairs (RA) Publishing with 1-3 years of experience in regulatory submissions across global markets including the US, UK, EU, and ROW (Rest of World). The ideal candidate will have a background...


  • Hyderabad, Telangana, India Medtronic Full time ₹ 5,00,000 - ₹ 12,00,000 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...


  • Hyderabad, Telangana, India Dr Reddys Laboratories Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Regulatory Affairs Analyst 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...


  • 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...


  • Hyderabad, Telangana, India Dr Reddys Laboratories Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Regulatory Affairs Analyst 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...