Regulatory Affairs

3 days ago

Chennai Tamil Nadu, India Ababil Healthcare Full time

Role - Regulatory Affairs - Medical Devices Experience - 1 to 3 Years Location- Madhavaram Chennai Budget - As per the industry Key Responsibilities 1 Regulatory Submissions Prepare and submit regulatory documents to authorities for approval such as new product applications amendments and supplements 2 Compliance Ensure products meet regulatory requirements including safety efficacy and quality standards 3 Regulatory Intelligence Stay up-to-date with changing regulations guidelines and industry standards 4 Risk Management Identify and mitigate risks associated with products or processes 5 Collaboration Work with cross-functional teams including R D Quality and Manufacturing 6 Documentation Maintain accurate and detailed records of regulatory activities including submissions approvals and compliance Requirements 1 Education Bachelor s degree in a relevant field such as life sciences pharmacy or engineering 2 Experience Prior experience in regulatory affairs quality assurance or a related field 3 Knowledge Strong understanding of regulatory requirements guidelines and industry standards 4 Communication Excellent written and verbal communication skills 5 Analytical Ability to analyze complex regulatory information and identify key issues Skills 1 Regulatory writing Ability to write clear concise and compliant regulatory documents 2 Project management Ability to manage multiple projects and prioritize tasks effectively 3 Attention to detail Strong attention to detail and ability to ensure accuracy and compliance 4 Collaboration Ability to work effectively with cross-functional teams and build strong relationships Certifications 1 RAC Regulatory Affairs Certification A certification offered by the Regulatory Affairs Professionals Society RAPS that demonstrates expertise in regulatory affairs Overall a Regulatory Affairs professional plays a critical role in ensuring compliance with regulatory requirements and facilitating the development and approval of products

  • Regulatory Affairs Executive

    3 hours ago

    Ambattur, Chennai, Tamil Nadu, India Gesco Healthcare Pvt Ltd Full time

    Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...

  • Regulatory Affairs Executive

    3 hours ago

    Tambaram, Chennai, Tamil Nadu, India Regenix Biosciences Ltd Full time

    Experience: 0 to 1 years of experience in Regulatory affairs. Qualification: B. Pharm / M. Pharm / MSc. Biotechnology Description: Regulatory Affairs Handling Dossiers License Queries CFT Communication Life cycle etc. *Immediate Joiners* Excellent in Communication Application Question(s): - Current CTC - Expected CTC - Notice...

  • Regulatory Affairs Executive

    2 weeks ago

    Perungudi, Chennai, Tamil Nadu, India MORULAA HEALTH TECH PVT LTD Full time

    Job Summary The Regulatory Affairs Specialist is responsible for ensuring compliance with all applicable regulations governing the development, manufacturing, and distribution of the company's products. This role involves collaborating with internal teams and regulatory agencies to facilitate product registrations, approvals, and adherence to quality...

  • Regulatory Affairs Executive

    2 weeks ago

    Tambaram, Chennai, Tamil Nadu, India Regenix Biosciences Ltd Full time

    **Experience**: 1 to 2 years of experience in Regulatory affairs. **Qualification**: B. Pharm / M. Pharm / MSc. Biotechnology **Description**: - Regulatory Affairs - Handling Dossiers - License - Queries - CFT Communication - Life cycle etc. **Immediate Joiners** Excellent in Communication **Job Types**: Full-time, Permanent Pay: Up to ₹28,000.00...

  • Regulatory Affairs Executive

    3 hours ago

    Chennai, Tamil Nadu, India LUMBAR HEALTHTECH PVT LTD Full time

    Full job description **Key Responsibilities**: - Monitor and stay up-to-date on regulatory changes and requirements in different regions. - Communicate with regulatory authorities and answer their queries or requests. - Ensure product labeling and packaging meet regulatory standards. - Maintain records of regulatory submissions, approvals, and...

  • Regulatory Affairs Executive

    2 weeks ago

    T Nagar, Chennai, Tamil Nadu, India Mi Lifestyle Marketing Global Private Limited Full time

    **Greetings from Mi Lifestyle Marketing Global Pvt Ltd!!!!!!** We have a job opening for a Regulatory Affair with a minimum of 4+ years of experience. Hindi speaking will be an added advantage. **Location**: Chennai, T Nagar **Qualification**:B. Tech(Food Technology) **Responsibilities**: 1. Product Development & Regulatory Compliance 2. FSSAI & AYUSH...

  • Executive Regulatory Affairs

    6 days ago

    Perungudi, Chennai, Tamil Nadu, India Morulaa HealthTech Pvt Ltd Full time

    **Primary Responsibilities**: - **Regulatory Compliance**: Ensure that company products and processes comply with relevant regulations, such as FDA (21 CFR Part 820), ISO 13485, EU MDR, IEC 62304 ISO 20417, ISO 15223, ISO 10993-1 and other global standards. GSPR, Technical Documentation, Regulatory Gap Assessment. - Standard Operating Procedure (SOP) -...

  • Regulatory Affairs Executive

    4 days ago

    Karapakkam, Chennai, Tamil Nadu, India CellBios Healthcare & Lifesciences Pvt. Ltd Full time

    **Key Responsibilities**: - **Regulatory Compliance**: Ensure compliance with ISO 13485, EU MDR 2017/745, US-FDA, CDSCO, and other applicable international standards for medical devices. - **Submissions and Approvals**: Prepare, review, and submit regulatory documentation, including 510(k) and IMDR submissions, to regulatory authorities such as US-FDA,...

  • Regulatory Affairs Executive

    3 weeks ago

    Chennai, India Medopharm Full time

    Job Description: Regulatory Affairs Executive (ROW Markets) Industry: Pharmaceuticals Experience: 3-5 Years Loaction: Chennai Key Responsibilities: Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets. Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers. Document Review: Review...

  • Regulatory Affairs Executive

    2 weeks ago

    Chennai, Tamil Nadu, India Medopharm Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Description: Regulatory Affairs Executive (ROW Markets)Industry: PharmaceuticalsExperience: 3-5 YearsLoaction: ChennaiKey Responsibilities:Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets.Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers.Document Review: Review BMR,...