Regulatory Affairs Executive

2 days ago

Indiranagar Bengaluru Karnataka, India Kerala Ayurveda Limited Full time

**Key Responsibilities**
- **Regulatory Compliance (India)**:

- Ensure product compliance as per **Drugs & Cosmetics Act**, **AYUSH guidelines**, and **FSSAI** standards.
- Prepare and review technical documents, dossiers, and regulatory submissions.
- **Labeling and Claims Review**:

- Review and approve all labels, artwork, and marketing claims for compliance with **Indian regulations**, **Magic Remedies Act**, and international standards.
- Work closely with Marketing, R&D, and Legal teams to ensure all packaging and promotional materials are regulatory compliant.
- **International Regulatory (US/EU)**:

- Support documentation as per **USFDA dietary supplement** regulations (21 CFR), including structure/function claim substantiation and DSHEA compliance.
- Assist in preparing dossiers and responding to queries related to **EFSA (EU)** compliance, including Novel Food dossiers if needed.
- Coordinate with cross-functional teams for Prop 65 warnings, allergen declarations, and supplement fact panels.
- **Documentation and Audit Readiness**:

- Maintain regulatory records and product master files.
- Prepare for and support internal audits and regulatory inspections.
- Stay updated with changes in national and international regulations and advise the team accordingly.
- **Education**: B.Pharm/M.Pharm Regulatory Affairs
- **Experience**: Minimum 5 years in a Regulatory Affairs role handling both domestic and international markets
- **Technical Skills**:

- Strong understanding of D&C Act, AYUSH regulations, FSSAI compliance
- Familiarity with USFDA dietary supplement guidelines (including NDI, GRAS) and EFSA regulatory pathways
- Working knowledge of QMS, GMP, and documentation standards

**Job Types**: Full-time, Permanent

Pay: ₹700,000.00 - ₹1,000,000.00 per year

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund

Schedule:

- Day shift

Work Location: In person

Application Deadline: 11/07/2025

  • Business Development Executive

    2 days ago

    Bengaluru, Karnataka, India Silmed Scientific - Global Regulatory Affairs Partner Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Company DescriptionSilmed Scientific is a global leader in regulatory affairs, specializing in delivering comprehensive end-to-end regulatory solutions for pharmaceuticals, medical devices, and biosimilars. With expertise in regulatory strategy and successful drug development, the company supports approvals across global markets including Europe, the US,...

  • Regulatory Affairs Manager

    2 weeks ago

    Bengaluru, Karnataka, India Kumar Organic Products Full time

    Job Title: Regulatory Affairs ManagerDepartment: Regulatory Affairs / Quality & ComplianceReporting to: Head Regulatory AffairsJob Purpose:To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing...

  • Regulatory affairs executive

    4 weeks ago

    Bengaluru, India Halma Plc Full time

    About Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...

  • Regulatory affairs executive

    5 days ago

    Bengaluru, India Halma Plc Full time

    About Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...

  • regulatory affairs

    3 weeks ago

    bengaluru, India Randstad Full time

     What do we offer you? Competitive salary and benefits packageRemote work opportunitiesProfessional development and growth opportunitiesCollaborative and supportive team environmentChance to make a significant impact on a global scaleWork-life balance Who are you?We are looking for a dedicated and experienced Regulatory Affairs Specialist to join our...

  • International Regulatory Affairs Manager I

    6 days ago

    Bangalore, Karnataka, India AstraZeneca Full time

    Job Title International Regulatory Affairs Manager I Global Career Level D1 Introduction to role Within International Regulatory Affairs we take innovative regulatory approaches to bring life-changing medicines to patients in international markets We work across the AstraZeneca pipeline and business to accelerate regulatory approvals for new medicines in...

  • Regulatory Affairs Associate

    4 hours ago

    Bengaluru, India ANRGI TECH Pvt. Ltd. Full time

    Job Title: Regulatory Affairs Associate – Authoring.  Role detailed classification Regulatory Affairs Authoring Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring and/or other...

  • Regulatory Affairs Associate

    4 hours ago

    Bengaluru, India ANRGI TECH Pvt. Ltd. Full time

    Job Description Job Title: Regulatory Affairs Associate – Authoring.  Role detailed classification Regulatory Affairs Authoring Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring...

  • Regulatory Affairs Analyst Ii

    4 days ago

    Bangalore, Karnataka, India Waters Full time

    Overview The Regulatory Affairs Specialist II has primary responsibility for provision of In Vitro Diagnostic regulatory support to prepare execute and maintain regulatory filings including change management support of post market requirements and support of outside vendors e g license holders in country representatives Secondary responsibility would be to...

  • Regulatory Affairs Executive

    4 weeks ago

    Bengaluru, India Halma plc Full time

    About Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...