Regulatory Affairs Specialist

8 hours ago

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

  • 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

    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...

  • 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....

  • 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,...

  • 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...

  • Walk in Drive API Regulatory Affairs Dept

    7 days ago

    Hyderabad, Telangana, India MSN Group Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Role & responsibilitiesWalk In Drive for API Regulatory Affairs Dept (RA) @ R&D CenterWork Location :- MSN Laboratories Pvt. Ltd.MSN R&D center, Pashamylaram, Isnapur, Patancheru, SangareddyInterview Date: @Saturday & @SundayInterview Time :- 9AM TO 5PMVenue Details :Quality Inn RamachandraWard No- 58, 31-41/10/1, Duvvada, Revenue, Visakhapatnam, Andhra...

  • Regulatory Affairs Assistant

    2 days ago

    Hyderabad, Telangana, India Gamut HR Solutions Full time ₹ 5,00,000 - ₹ 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 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...

  • Regulatory Affairs Analyst

    2 hours ago

    Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    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 becauseGood Health Can't Wait.We started in 1984 with a modest investment, 20 employees and a bold...

  • 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...