15h Left Regulatory Affairs Sr. Manager

3 days ago

Rajkot, Gujarat, India BioMatrix Healthcare Full time

Company OverviewBBioMatrix Healthcare Private Limited 100 export-oriented company headquartered at Ahmedabad Gujarat India was established in 2007 with a thought of Supporting Life Worldwide The company is engaged in R D and manufacturing of oral solids liquids and dry syrups Our manufacturing facility has been accredited by WHO-GMP successfully completed an EU-GMP audit recently and complies with ANVISA UKMHRA and USFDA regulations With a significant presence in African and CIS regions we export our products to over 30 countries We are now planning to expand our presence in Europe Latin America and South East Asian markets We have over 850 product registrations with more than 400 products under registrations across Europe CIS and African countries We are grateful that you are interested in working with BioMatrix Healthcare Pt Ltd As we are moving further we have arranged walk-in interview as per the details given below Kindly go through the details and confirm your availability Job OverviewWe are seeking a Regulatory Affairs Senior Manager at our Ahmedabad location This is a full-time position requiring a minimum of 7 years of work experience The candidate will be responsible for ensuring compliance with drug regulations leading the regulatory affairs team and supporting our expansion into new markets Qualifications and SkillsB pharm M pharm Regulatory Compliance Mandatory skill Expertise in maintaining compliance with local and international drug regulatory authorities FDA Regulations Mandatory skill Thorough understanding and experience with FDA regulatory procedures and policies Job LocationSindhubhavan Road Thaltej AhmedabadRoles and Responsibilities Overall responsibility for managing regulatory submissions for respecting Zone query responding and product life-cycle maintenance for the companys portfolio Leading a team of regulatory professionals To plan prepare and review of high-quality eCTD dossier with support and guidance assuring technical congruency and regulatory compliance meeting agreed-upon timelines Renewal Application Ensuring planning and proper organization of regulatory activities and resources within the team Independent interaction with the companys overseas client for regulatory-related matters Established a system of recording technical comments from various regulatory teams on change control imitated by R D or manufacturing plant

  • Senior Regulatory Affairs Lead

    3 days ago

    Rajkot, Gujarat, India beBeeRegulatory Full time US$ 1,50,000 - US$ 3,00,000

    Job OverviewWe are seeking a Senior Manager to lead our Regulatory Affairs function at our location in Ahmedabad. This is a full-time position requiring a minimum of 7 years of work experience.Responsibilities:Develop and implement regulatory strategies to ensure compliance with global regulations.Lead cross-functional teams to obtain product registrations...

  • Senior Regulatory Compliance Expert

    3 days ago

    Rajkot, Gujarat, India beBeeRegulatory Full time ₹ 12,00,000 - ₹ 15,00,000

    The role of Senior Regulatory Affairs Specialist requires strategic leadership in managing the lifecycle of regulatory activities for USFDA submissions.As a key member, you will oversee the preparation, review, and filing of ANDA submissions, Annual Reports, amendments, and deficiency responses. You will collaborate with cross-functional teams to gather...

  • 15h Left Sales Manager

    7 days ago

    Rajkot, Gujarat, India TATA CAPITAL Full time ₹ 1,50,00,000 - ₹ 2,00,00,000 per year

    To drive sales and ensure business targets are achievedo Aggressively drive the sales numbers and achieve the business targets for Retail loan products and through cross selling while continuing to enhance and upgrade the client relationships.o Retain and expand the company's base of customers for retail loan product so as to ensure repeat business or...

  • Sr Executive

    3 weeks ago

    Rajkot, Gujarat, India CIEL HR Full time

    Number of vacancies s01Name of Reporting Manager Emp no Sr GM-Innovation CenterLocation of workDahejNature of task to be performed if required more details can be shared with Job description- Dry blend preparation operation of extrusion of PVC pipes profiles and CPVC Pipes - Should have knowledge of handling of highspeed mixer preparation of PVC or...

  • Executive Director of Operations

    20 hours ago

    Rajkot, Gujarat, India beBeeOPERATIONS Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    The Chief Operating Officer plays a pivotal role in the company's strategic direction and operational success. This senior leadership position requires a seasoned professional to drive business growth, improve operational efficiency, and ensure regulatory compliance.Key Responsibilities:Strategic Leadership: Develop and implement long-term vision and...

  • Liaison Officer

    4 weeks ago

    Rajkot, Gujarat, India Adept Consulting Partners Full time

    We're hiring a Sr. Manager/Manager – Liaison to ensure smooth regulatory coordination and compliance for our reputed client (Gujarat plant) Location: Gujarat Experience: 10–15 years in Manufacturing or related industries Qualification: Graduate/PG Role Type: Individual ContributorThe role involves dealing with local authorities, audits, compliance, and...

  • Strategic Client Manager

    3 days ago

    Rajkot, Gujarat, India beBeeRelationship Full time ₹ 6,00,000 - ₹ 12,00,000

    Job DescriptionWe are seeking a highly skilled and experienced professional to manage key client relationships and drive business growth. As a key member of our team, you will be responsible for identifying new business opportunities, developing and maintaining strong relationships with existing clients, and collaborating with internal teams to resolve...

  • Highly Experienced Senior Medical Device Specialist

    3 hours ago

    Rajkot, Gujarat, India beBeeDevice Full time ₹ 15,00,000 - ₹ 25,00,000

    Job Title: Senior Device EngineerAbout the Role:We are seeking a highly experienced senior device engineer to fill this exciting opportunity.This position requires a seasoned professional with a strong background in medical devices and quality management.Main Responsibilities:Develop Quality Management Systems: Implement quality management systems that meet...

  • Senior Device Engineer

    7 hours ago

    Rajkot, Gujarat, India Sofomation Full time

    OPENING FOR A WELL KNOWN OIL AND GAS COMPANY In MIDDLE EAST: Position: Medical Devices-Assessor/ Auditor Experience: Require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory...

  • Chief Operating Officer

    1 day ago

    Rajkot, Gujarat, India Red Envelope Consultants Full time

    Role - COOClient - ConfidentialIndustry - Pharmaceutical (OSD)Location - AhmedabadYOE - 15+Key Responsibilities:- Strategic Leadership- Operational and Financial Oversight- Regulatory and Compliance Management- Team Leadership and Culture- Stakeholder and Market RelationsEducation and Knowledge- Bachelor's degree in Business Administration, Management, or a...