Current jobs related to Regulatory Document Specialist - meerut - beBeeRegulatory

  • Regulatory Affairs Specialist –

    2 weeks ago

    meerut, India vueverse. Full time

    Key Responsibilities: Regulatory Submissions & Compliance Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others. Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5). Convert and prepare dossiers in...

  • Regulatory Affairs Expert

    2 weeks ago

    meerut, India beBeeRegulatory Full time

    Job Description: We are seeking a skilled Regulatory Affairs Specialist to lead our regulatory submissions and compliance efforts. The ideal candidate will have 8-10 years of experience in handling submissions across regulated and RoW markets, with a strong understanding of global dossier formats, submission pathways, and lifecycle management.The successful...

  • Regulatory Affairs Specialist

    4 days ago

    Meerut, India Naari Pharma Pvt Ltd. Full time

    Lead end-to-end regulatory activities for Emerging and Regulated Markets, including submissions, approvals, and post-approval changes. Encompassing pre- and post-approval phases such as initial submissions, query responses, variations, renewals, and ongoing post approval maintenance. The role demands strong expertise in global regulatory requirements,...

  • Data Remediation Specialist

    2 weeks ago

    meerut, India beBeeRemediation Full time

    Remediation Specialist for Labeling Data ManagementThe ideal candidate will review, validate and correct product labeling data across various systems ensuring accuracy, alignment with regulatory standards and local market requirements.Gaps and inconsistencies in existing labeling records need to be identified.Labeling fields must be remediated to match...

  • Regulatory Affairs Manager

    3 weeks ago

    Meerut, India Whatjobs IN C2 Full time

    About the Company: Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts. Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...

  • Global Regulatory Compliance Specialist

    5 days ago

    meerut, India beBeeRegulatory Full time

    Job OpportunityThe Senior Regulatory Affairs Associate role requires a professional with expertise in preparing and delivering regulatory submissions from a global and regional perspective. Your contributions will be pivotal in ensuring compliance with regulatory frameworks across various regions.Prepare and review Marketing Authorization Applications &...

  • Software Documentation Expert

    1 week ago

    meerut, India beBeeTechnical Full time

    Documentation Specialist OpportunityWe are seeking a skilled Documentation Specialist to join our team and contribute to the creation of high-quality technical documentation for software and technology domains.Responsibilities:Develop and maintain detailed, accurate documentation to support product development and customer success.Collaborate closely with...

  • Digital Documentation Specialist

    7 days ago

    meerut, India beBeeDocumentation Full time

    Job DescriptionWe transform financial institutions into digital leaders.As a professional team of global scale, we collaborate with clients for projects in an environment where we learn amazing things every day. Each code, each voice, each contribution, each challenge, each success is celebrated here.The Technical Writer plays a critical role in our...

  • Compliance Specialist

    4 days ago

    meerut, India beBeeCompliance Full time

    Job Title: Compliance SpecialistThe modern business landscape is transforming at an unprecedented rate, with companies operating globally and adapting to new regulations and compliance requirements.Multiply your expertise as a Compliance Specialist in our company, working closely with various teams to ensure all activities are carried out in accordance with...

  • AI Specialist in Healthcare

    4 days ago

    meerut, India beBeeArtificialIntelligence Full time

    Artificial Intelligence Specialist in HealthcareWe are seeking a highly skilled Artificial Intelligence Specialist to join our team. The successful candidate will work closely with our experts to develop and implement AI solutions that improve healthcare outcomes.Key Responsibilities:Develop and deploy AI models for healthcare applications.Analyze large...

Regulatory Document Specialist

2 weeks ago

meerut, India beBeeRegulatory Full time

Job Title: Regulatory Document SpecialistWe are seeking a skilled professional to create, update, and manage regulatory and clinical documents for medical device projects. This is a full-time, site-based role on a 12-month fixed-term contract with the potential for extension.Create and update CERs, SSCPs, SOAs, and LRRs in compliance with applicable regulatory requirements and guidelines.Participate in systematic literature reviews, including search, screening, data extraction, analysis, and synthesis.Summarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devices.Compare device safety and performance against the state of the art and investigate unexpected outcomes.You will utilize various software systems to create required documents and follow all company procedures, regulatory guidelines, and health, safety, and environmental practices. The ideal candidate will have strong communication skills and be able to collaborate with cross-functional teams.Required Skills and QualificationsTo succeed in this role, you will need:A degree in life sciences or a related field (BA, BS, or BSN). An advanced degree is preferred.A minimum of 3 years' experience in medical writing or related roles, preferably in the medical device industry.Familiarity with CER regulatory requirements, evidence generation, and literature reviews.Strong oral communication, presentation, project management, and prioritization skills.BenefitsThis is an exciting opportunity to contribute to regulatory and scientific documentation within the medical device sector while working in a collaborative, cross-functional environment.The role offers the chance to work on a range of complex documents, develop your expertise in medical writing, and make a meaningful contribution to our team's success.