Head Regulatory Affairs

3 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.

  1. Regulatory Strategy and Compliance:

  2. Develop and implement regulatory strategies for product formulations to ensure compliance with all applicable regulations and guidelines.

  3. Stay updated with changes in regulatory environments and proactively assess their impact on product formulations.

  4. Regulatory Submissions:

  5. Oversee the preparation, review, and submission of regulatory documents, including INDs, NDAs, ANDAs, CTDs, and other regulatory filings.

  6. Ensure timely submissions and approvals by regulatory authorities such as FDA, EMA, and other global agencies.

  7. Cross-Functional Collaboration:

  8. Work closely with R&D to ensure that regulatory requirements are integrated into the product development process.

  9. Collaborate with quality assurance and manufacturing teams to ensure compliance during product formulation, testing, and production.

  10. Regulatory Guidance and Training:

  11. Provide regulatory guidance and training to internal teams to ensure understanding and compliance with regulatory requirements.

  12. Serve as the primary point of contact for regulatory matters related to formulations.

  13. Regulatory Intelligence:

  14. Monitor and analyze regulatory trends, changes, and advancements in the industry.

  15. Communicate relevant regulatory updates and implications to internal stakeholders.

  16. Documentation and Record Keeping:

  17. Maintain accurate and comprehensive records of regulatory submissions, correspondence, and approvals.

  18. Ensure that all regulatory documentation is up to date and readily accessible for audits and inspections.

  19. Regulatory Agency Interactions:

  20. Manage relationships and communications with regulatory agencies.

  21. Prepare for and lead regulatory agency meetings and inspections related to formulations.

  • Regulatory Affairs

    3 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...


  • 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 Growthspirit Trading Pvt. Ltd. Full time ₹ 15,000 - ₹ 28,00,000 per year

    Job Summary:The Head of Corporate Affairs will be responsible for developing and implementing corporate affairs strategies, programs, and policies to enhance the company's image and brand in line with its mission and vision. This role involves building relationships with key stakeholders, advocating for favorable policies, and ensuring compliance with...


  • 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,...


  • 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...


  • 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 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...


  • 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...


  • 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...


  • 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....