Regulatory Affairs Manager

2 days ago

Hyderabad, Telangana, India Shri Kartikeya Pharma Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Job Summary:

The Regulatory Affairs Manager will oversee all regulatory compliance activities related to the companys nutraceutical products, ensuring that all the marketing practices meet applicable global standards (e.g., FDA (U.S.), EFSA (EU), FSSAI (India).

Key Responsibilities:

Regulatory Strategy & Compliance.

  • Develop and implement regulatory strategies for product launches and market expansions.
  • Ensure the certifications are renewed on time and also apply for new certifications in new geographies.
  • Interpret and apply country-specific regulations (FDA/DSHEA, EFSA, FSSAI, etc.) to ensure compliance.

Dossier & Documentation Management.

  • Prepare and maintain regulatory submissions, including product dossiers, GRAS documentation, and ingredient justifications.
  • Ensure technical files and records (safety data, clinical support for claims, specifications) are audit-ready.

Labelling, Claims & Marketing Review.

  • Review and approve labels, packaging, and marketing materials for regulatory compliance.
  • Evaluate substantiation for health and structure/function claims to ensure legal acceptability.

Cross-functional Collaboration

  • Collaborate with R&D, Quality, Marketing, and Legal teams to align product development with regulatory requirements.
  • Provide regulatory support during product lifecycle management and reformulations.

Regulatory Liaison

  • Act as the point of contact with national and international regulatory agencies (e.g., FDA, EFSA, FSSAI, TGA).
  • Lead the response to agency inquiries, inspections, or compliance reviews.

Training & Risk Management

  • Provide internal training on new regulations and compliance procedures.
  • Identify and mitigate regulatory risks associated with ingredients, claims, or labelling.

Required Qualifications:

  • Bachelor's or Master's degree in Pharmacy, Food Science, Chemistry, Life Sciences, or a related discipline.
  • 5+ years of experience in regulatory affairs in the nutraceutical, dietary supplement, or functional foods sector.
  • Strong knowledge of international regulatory frameworks: FDA/DSHEA (U.S.), EFSA (EU), FSSAI (India).
  • Familiarity with Codex Alimentarius and GMP guidelines preferred.
  • Excellent written and verbal communication skills.
  • Attention to detail and experience handling complex documentation.

Preferred Experience:

  • Experience with digital regulatory platforms or document management systems.
  • Experience interacting directly with regulatory authorities or participating in audits/inspections.
  • Regulatory submissions for new ingredients, import/export regulatory support.

  • Regulatory Affairs

    7 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...

  • Regulatory Affairs Specialist

    5 days 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 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...

  • Executive Regulatory Affairs

    2 weeks 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 Manager

    7 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...

  • Senior Regulatory Affairs Specialist

    2 weeks 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 Assistant

    7 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- eCTD Specialist

    4 days 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 Lead, Project Manager

    3 weeks ago

    Hyderabad, Telangana, India, Telangana ArtiXio Full time

    About the Role We are looking for a Regulatory Affairs Lead/ Project Manager to join our dynamic team. The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health Authorities in Asia, LATAM, or other international markets. This role requires strong leadership, high attention to...

  • Regulatory Affairs Specialist

    1 hour ago

    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...