Senior Regulatory Affairs Trainer

3 weeks ago

Guntur Andhra Pradesh India, Andhra Pradesh Tek Support Part time

Job Title: Regulatory Affairs

Location: Remote

Job type: Part-time


Job Summary:

We are seeking a highly experienced Regulatory Affairs Trainer with over 10 years of expertise in global regulatory compliance, submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be responsible for designing and delivering advanced training programs that equip professionals with the knowledge and skills required to manage complex regulatory processes, ensure compliance with international standards, and handle audits effectively.


Key Responsibilities:

  • Develop and deliver comprehensive training modules on regulatory submissions, including IND, NDA, ANDA, 510(k), PMA, CE Marking, and country-specific registrations.
  • Provide hands-on training in FDA, EMA, ISO 13485, ICH, and country-specific regulatory compliance.
  • Train teams on labeling review and artwork compliance to meet global standards.
  • Educate participants on regulatory strategy and lifecycle management for products, including renewals, variations, and post-market surveillance.
  • Conduct training on audit preparation, mock inspections, and CAPA (Corrective and Preventive Actions).
  • Develop case studies and practical exercises on regulatory risk assessment and submission dossier preparation (CTD/eCTD format).
  • Collaborate with cross-functional teams to align training content with quality, manufacturing, and R&D requirements.
  • Mentor junior regulatory professionals on industry best practices and career development.
  • Maintain up-to-date knowledge of global regulatory changes and incorporate them into training programs.
  • Provide post-training assessments, feedback, and continuous improvement of training materials.


Required Skills & Expertise:

  • 10+ years of experience in Regulatory Affairs in medical devices, pharmaceuticals, biotech, or FMCG.
  • Proven expertise in regulatory submissions (IND/NDA/ANDA, 510k, CE Marking, PMA).
  • Strong understanding of FDA, EMA, ISO 13485, ICH, GxP, and other global regulations.
  • In-depth knowledge of labeling compliance, product registrations, renewals, and lifecycle management.
  • Experience in audit management, regulatory inspections, and remediation planning.
  • Excellent communication, presentation, and mentoring skills.
  • Ability to simplify complex regulatory concepts for diverse audiences.


Preferred Qualifications:

  • Master’s degree in Pharmacy, Biotechnology, Life Sciences, or Regulatory Affairs (preferred).
  • RAC (Regulatory Affairs Certification) or equivalent professional certification.
  • Experience training or mentoring regulatory professionals in corporate or consulting settings.

  • Senior Sustaining Engineer/Male&Female

    7 days ago

    Guntur, Andhra Pradesh, India Tek Support Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Job Title:Sustaining Engineer TrainerLocation:RemoteEmployment type:Part-timeJob Summary:We are seeking an experiencedSustaining Engineer Trainerwith over10 yearsof hands-on experience in supporting products through theirfull lifecycle, implementing design changes, driving CAPA initiatives, performing root cause analysis, improving product reliability, and...

  • Co ordinator

    1 week ago

    Guntur, Andhra Pradesh, India Shivexim Full time ₹ 15,000 - ₹ 1,80,000 per year

    elaborate for a job postingconditions : female onlyneed stay in hostel.role : jr trainerwomens hostelHere is an elaborated job posting for the role of Junior Trainer with the specified conditions:*****Job Opening: Junior Trainer (Female Only)****Location:** Guntur**Accommodation:** On-site Women's Hostel (Mandatory stay)**About the Role:**We are seeking a...

  • Full Stack Development Internship in Guntur

    1 week ago

    Guntur, Andhra Pradesh, India PHARMA RESEARCH Full time ₹ 3,00,000 - ₹ 6,00,000 per year

    We are building a web-based portal, SOC-RP ID system, for clinical research professionals. The portal will manage candidate registrations, certification programs, unique SOC-RP IDs, digital certificates with QR codes, and verifiable public profiles.Selected Intern's Day-to-day Responsibilities IncludeAssisting in developing candidate registration and...

  • Full Stack Web Developer Internship in Guntur

    2 weeks ago

    Guntur, Andhra Pradesh, India PHARMA RESEARCH Full time ₹ 6,00,000 - ₹ 8,00,000 per year

    Selected Intern's Day-to-day Responsibilities IncludeFrontend DevelopmentDesigning and developing responsive candidate registration, login, and dashboard pages using , HTML, CSS, TailwindCSS/Bootstrap.Ensuring a clean, user-friendly UI/UX for candidates and admin users.Backend DevelopmentAssisting in building REST APIs using + Express OR Python...

  • Agriculture spraying Drone Pilot

    1 week ago

    Guntur, Andhra Pradesh, India Aerominds Pvt Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Position: Senior Agricultural Spraying Drone Pilot Location: Guntur & Nellore, Andhra Pradesh Experience: Minimum 1 year Certification: DGCA-approved Small or Medium Class Remote Pilot Certificate Key Responsibilities: 1) Operate advanced agricultural spraying drones with precision and efficiency in field environments. 2) Ensure full compliance with safety,...

  • Quality Assurance Lead

    2 weeks ago

    Guntur, Andhra Pradesh, India HOME THALI PRIVATE LIMITED Full time ₹ 3,84,000 per year

    Job Title: Quality Assurance LeadLocation: [Guntur, Andhra Pradesh]Job Overview:A Quality Executive Lead is a senior leadership role in the quality assurance / quality control (QA/QC) function. The person leads a team responsible for ensuring products, processes, or services meet internal standards, regulatory requirements, and customer expectations. They...

  • Female Quality Assurance Lead

    2 weeks ago

    Guntur, Andhra Pradesh, India HOME THALI PRIVATE LIMITED Full time ₹ 3,04,000 - ₹ 3,84,000 per year

    Job Title: Female Quality Assurance LeadLocation: [Guntur, Andhra Pradesh]Job Overview:A Quality Executive Lead is a senior leadership role in the quality assurance / quality control (QA/QC) function. The person leads a team responsible for ensuring products, processes, or services meet internal standards, regulatory requirements, and customer expectations....

  • Senior Administration Executive

    7 days ago

    Guntur, Andhra Pradesh, India Growthspirit Trading Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Key Responsibilities:Handle all land-related matters including property documents, registration, mutation, title verification, and lease agreements.Liaise with government authorities, municipal bodies, revenue departments, collector and tehsildar offices, and other regulatory agencies.Manage land acquisition, lease renewals, and compliance processes.Ensure...

  • Senior Insurance Executive

    2 weeks ago

    Guntur, Andhra Pradesh, India 7hills pharmacy Full time ₹ 18,00,000 - ₹ 54,00,000 per year

    Core responsibilitiesClient consultation: Assess client needs and provide expert advice on health insurance policies, benefits, and coverage options.Sales and enrollment: Help clients select the most suitable plan based on their budget and requirements, and assist them with the application and enrollment process.Policy and claims management: Assist clients...

  • Senior Data Engineer

    7 days ago

    Guntur, Andhra Pradesh, India Xped pvt Ltd Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    JOB DESCRIPTION :Responsibilities : - Collaborate with Data Engineers and Data Scientists to integrate and process structured and unstructured data sets into actionable insights. - Optimize PySpark jobs and data pipelines for performance, scalability, and reliability. - Conduct regular financial risk assessments to identify potential vulnerabilities in...