Hire the best Biotechnology Regulatory Affairs Freelancers in India

Check out Biotechnology Regulatory Affairs Freelancers in India with the skills you need for your next job.
  • $40 hourly
    With over 8 years of experience in the industry, I am a seasoned QARA professional specializing in quality management systems and regulatory compliance. Here is a brief overview of my proficiency and background. - Specialization in ISO 13485 and 21 CFR-compliant Quality Management Systems for medical device manufacturers. I have set up the QMS for 6 medical device manufacturers to date. - Regulatory Markets: Support regulatory compliance across India, the US, the UK, and Europeon market. Plan and support 510(K) approvals. - MDR 2017/745 services for CE certification: Provide MDR services such as clinical evaluation and post-market surveillance for over 40 medical devices. - Audit Excellence: Certified internal auditor, adept at comprehensive audits for continuous improvement. -Hands-on experience with project management: I have successfully led a team of 30 individuals through the intricacies of a product development program (Software+Hardware). Some of the International clients I have worked with are; CIRCA Scientific MC3 Corp Varex Imaging Asensus Surgical Channel Medsystems Morair Medtech Micrima Limited Better Medicine NeuroMagnetics Australia
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Drug Regulation
    Biotechnology Regulation
    Medical Device User Manual
    Internal Auditing
    Software Documentation
    Software Development
    Software
    Quality Management System
    Quality Assurance
    Quality Control
    Technical Writing
    Project Risk Management
    Scientific Research
    Medical Device
    Scientific Writing
    Regulatory Compliance
    Technical Documentation
  • $12 hourly
    I am a postgraduate (M.Pharma-Pharmaceutics), having 10 years of experience in Manufacturing, Contract manufacturing, SOP, Documentation, regulatory affairs, GMP and HACCP Expert, ISO 9001 and 14001 Lead Auditor. Currently, I am working as a Project Manager in a Pharmaceutical MNC. ☆Key skills: Pharamceutical Medical device Standard operating procedure Contract manufacturing 21 CFR Part 11 compliance. GxP Compliance CTD dossiers, eCTD dossier, DMF writing (in Pharma). Preparation of regulatory submissions of medical devices, Maintain compliance of company with ISO 13485 and 93/42/EEC and 21 CFR 820 regulations and guidelines.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Science & Medicine
    Drug Regulation
    Software QA
    Biotechnology Regulation
    Pharmacovigilance
    Pharmaceutical Industry
    Good Manufacturing Practice
    Biotechnology
  • $10 hourly
    Experienced in Preparation of Scientific Planner as per customer need Handling and Quality Check of large database for structured data, searching of web based data Backend Data compilation and live entry of data for company’s product Familiarity and experience in using coding languages(Python) Excellent excel skills, mail merging Good knowledge of regulatory documentation and drug development process. Knowledge of regulatory guidelines for New Drugs approval, clinical trials, Registration, Import license of New Drug and Subsequent Drug, Test license in the country as per provisions of Drugs & Cosmetics Act & Rules. Knowledge of Schedule Y, ICH and Indian GCP guidelines for conduct of clinical studies in country. Understanding of the drug development and clinical process. Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) • Review of regulatory documents such as those associated with filings and dossiers, pertaining to clinical trials, market authorization, new drugs approval, clinical trial approval, BA/BE study approval this included study of investigation of clinical study reports, clinical study protocol, annual reports, investigator brochures, case record form, stability study data and other relevant manuscripts. • Handling of SAE (Serious Adverse Event) Reports and writing medically relevant safety narrative of case and checking the completeness of case, along with verification of the information/documents submitted by sponsor, investigator and ethics committee for the relatedness / non-relatedness of SAE that occurred during conduct of clinical trial, calculation of compensation amount to be paid to legal heir of subject/ subject as per provisions of Drugs and Cosmetics Rules 1940 along with verification of the information/ documents submitted by Sponsor, Investigator and Ethics Committee to make sure that the submission of data was done according to Schedule Y of D&C act, 1945 and identification of protocol deviations, misconducts during the clinical trial and Calculation of the compensation to the subject/ legal heir/ nominee as per 122 DAB and Appendix-XII of Schedule Y to Drugs & Cosmetics rules 1945, in case of SAE related to the Investigational product/ clinical trial. Scrutiny of applications pertaining to Import and Registration as per provisions of Drugs and Cosmetics Act, 1940 and Rules there under Evaluation of Bioequivalence and Clinical Trial Protocol and their reports, summarization of clinical data. Scrutiny of applications pertaining to Additional Indications, Additional Strengths, New Dosage Form, Package Insert Update, Ethics Committee Registration, PSURs, Post Marketing Surveillance Reports Work on knowledge output on Sector – reports published by FICCI, industry representations to government stakeholders like NPPA, Department of Pharmaceuticals, GoI, MoHFW presentations on thematic areas Develop concept notes/ proposals for projects, thematic discussion papers Develop and maintain documents templates and high-quality systems for tracking regulatory submissions, reports for policy briefs and representations, work on stakeholder consultations and meetings for policy discussions, provide policy feedback to relevant government in a structured manner. Execute outreach events and delegations, work with team to develop concept notes, budgets, and agenda for events Participate in various task force activities of Pharma committee and project meetings related to area(s) of responsibility. Implements all activities related to the preparation of e.g. abstracts, posters/ presentations, manuscripts or to the preparation and compilation of data and information into a single comprehensive package for pharma sector. Provide scientific expertise to sectoral team in the development of new business proposals like Proposal under Pharmaceutical Product Development Scheme to Department of Pharmaceuticals, MoCF, GoI Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documents for Pharma sector specific issues.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Drug Regulation
    Artificial Intelligence
    Medical Device
    Biotechnology Regulation
    eClinicalWorks
    Risk Assessment
    Secondary Research
    Procedure Development
    Pharmacovigilance
  • $20 hourly
    With over 15 years of industrial and academic expertise, I specialize in experiment design, protocol development, scientific writing, and molecular biology data analysis. Additionally, I offer professional English-to-Hindi translation services for technical documents, product descriptions, research summaries, and more.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Research & Development
    Microbiology
    Biotechnology
    Biochemistry
    Science
    Research Proposals
    Scientific Research
    Research Protocols
    Research Methods
    Microsoft Project
    Academic Research
    Research Paper Writing
    Biotechnology Regulation
    Research & Strategy
    Research Papers
  • $60 hourly
    "I am an active PhD researcher in biology with experience in molecular pathway designing and scientific illustration. I have a good understanding of cellular and molecular signaling pathways, so i can ink your innovative idea into a picture. I'm experienced in scientific research from CSIR-CIMAP with writing skills for scientific purposes. Area of My expertise: # Designing visually appealing and presentable biological illustrations # Writing scientific articles for journals and websites # Creating question banks for competitive exams in the field of science/ biology # Experiment designing and problem solving in pharmacological research # Hindi to English and English to Hindi translations of science based contents My assets: * Qualified CSIR NET-JRF, CGSET, GATE Life science exams * Crisp Answer Writing skills with concept clarity and points * Conscientious about work * Zealous about work Your ideas and my visualization skills can inspire the scientific community.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Website Content
    Editing & Proofreading
    Article Writing
    Art & Design
    Cellular Biology
    Research Paper Writing
    Research Summary
    Scientific Literature Review
    Biotechnology Regulation
    Pharmacology
    Molecular Biology
    Scientific Illustration
    Biological Illustration
  • $30 hourly
    Hello and welcome! I bring 12+ years of expertise in HPV research, molecular biology, and quality control testing of biological samples. With a passion for biotechnology, I specialize in producing high-quality scientific content, including research articles, literature reviews, and reports tailored to your needs. My expertise includes: Biotechnology and Molecular Biology In Vivo Testing and Biological Sample Analysis Quality Control for Diagnostics Scientific Writing and Research With a proven track record of accuracy, in-depth research, and attention to detail, I ensure that your projects meet the highest standards. Let’s collaborate to bring clarity and precision to your work. Feel free to reach out—I’d love to discuss your project goals!
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Biotechnology Regulation
    Biotechnology
    Life Science
    Thesis
    Science & Medicine
    Scientific & Technical Services
    Writing
  • $6 hourly
    Welcome! I am Dr. Pia Dey, a dedicated scientific writer and accomplished microbiologist specializing in producing high-quality research articles, publications, and blogs. My unique combination of academic expertise and creative flair allows me to craft engaging, accurate, and impactful content tailored to diverse audiences. Why Work with Me? I bring a rich blend of technical knowledge and storytelling ability to every project. With over six years of hands-on research experience in microbiology, molecular biology, and antimicrobial therapies, my scientific insights are grounded in real-world applications. Whether you need peer-reviewed research articles, review paper, book chapters, literature reviews, or thought-provoking blog posts, I have the expertise to deliver content that stands out. Academic Excellence and Research Expertise: I hold a Ph.D. in Microbiology from the University of Kalyani, where my research focused on developing novel therapeutic approaches against biofilm-forming bacteria of global public health concern. My work has been recognized in various high-impact journals, including International Journal of Medical Microbiology, Microbial Pathogenesis, and Frontiers in Anti-Infective Agents. My deep understanding of microbial mechanisms and cutting-edge research techniques ensures the scientific accuracy and credibility of all my written work. Areas of Expertise: 1. Microbiology & Molecular Biology: From antimicrobial resistance to biofilm formation and quorum-sensing inhibitors, I have authored multiple publications exploring these critical areas. 2. Health and Medicine: My writing spans topics such as probiotics, prebiotics, and their impact on the human microbiome and immune system. 3. Research Communication: I excel in translating technical findings into engaging narratives for both the scientific communities and general public. 4. Scientific Blogging & Articles: Skilled in creating blog posts and articles that make complex topics accessible and captivating. Publications and Achievements: My portfolio includes 10+ published articles in reputed journals and books. Highlights of my published work include: - Antimicrobial, antibiofilm and antivirulence effects of several phytochemicals like Naringin, Reserpine, Bacoside A against virulent strains of bacteria which are of global public health concern. - Insights into quorum-sensing-mediated virulence in Pseudomonas aeruginosa. - Reviews on the role of probiotics in enhancing immune function. - Studies addressing the aftermath of COVID-19 on antimicrobial resistance in low- and middle-income countries. These contributions reflect my commitment to advancing scientific understanding and addressing pressing global health challenges. Skills and Services: I offer a wide range of services designed to meet your scientific writing and communication needs: - Research article writing and editing. - Grant proposals and funding applications. - Literature reviews and systematic analyses. - Blog posts on microbiology, health, and biotechnology topics. - Data visualization and interpretation using tools like GraphPad Prism. I also possess advanced technical skills in molecular biology techniques, bioinformatics, and statistical analysis, ensuring all my written content is data-driven and meticulously detailed. Soft Skills: - Exceptional written and verbal communication. - Timely delivery and attention to detail. - Ability to tailor content for specific audiences, whether academic peers, industry professionals, or general readers. What Sets Me Apart? Both as a researcher and a writer, I understand the nuances of scientific discourse and the importance of accuracy. My academic journey, combined with my teaching experience as an Assistant Professor of Microbiology, gives me a unique ability to break down intricate topics while maintaining their scientific integrity. I am also adept at adhering to journal guidelines and ensuring seamless submissions. Let's Work Together Whether you're looking to publish groundbreaking research, develop compelling content for your blog, or communicate complex ideas with precision, I am here to help. My goal is to bring clarity, creativity, and impact to every project. Let’s collaborate to create exceptional content that resonates with your audience and achieves your objectives. Feel free to reach out, and let's make your next project a success!
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Scientific Literature Review
    Virtual Assistance
    Life Science
    Microbiology
    Research Protocols
    Research Methods
    Research & Development
    Research Summary
    Research Paper Writing
    Research Documentation
    Biotechnology Regulation
    Medical Editing
    Proofreading
    Academic Editing
    Content Writing
  • $8 hourly
    Organizes and motivated employee in the area of Biotechnology and Pharmaceuticals, eager to apply, time management and organizational skills in the above mentioned area. Seeking entry level opportunities to expand skills while facilitating the company growth.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Teaching
    ChatGPT
    Healthcare IT
    Biotechnology
    Biotechnology Regulation
  • $5 hourly
    I am student. Studying biotechnology and I can easily help out in a making any work easy and submit in due date and can provide afficent work
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Biotechnology Regulation
  • $12 hourly
    I’m a pharmacy professional with a bachelor’s degree from India and a master’s degree from the University of Queensland, Brisbane. I bring extensive experience in biopharmaceutical manufacturing, market research, and healthcare marketing. What I can do for you: Leverage my expertise in biopharmaceutical manufacturing to optimize processes and ensure product quality. Conduct detailed market research to uncover industry trends, competitive landscapes, and growth opportunities. Develop and implement strategic marketing initiatives tailored to the healthcare and pharmaceutical industries. Deliver seamless project management and clear communication for successful collaboration. I’m passionate about driving success through data-driven strategies and strong partnerships. Let’s work together to bring your ideas to life!
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Alternative Medicine
    Science & Medicine
    Chromatography
    Biotechnology
    Biotechnology Regulation
    Pharmaceuticals
    Herbal Medicine
    Pharmaceutical Industry
    Market Research
  • $11 hourly
    I am a passionate writer and a skilled biology teacher with a Master’s degree in Biotechnology and extensive experience in academic and scientific research. My expertise lies in simplifying complex biological concepts for learners and creating engaging, well-researched content on topics ranging from molecular biology and cancer research to educational materials and scientific publications. What I Do Best: Academic Writing: Crafting high-quality research articles, literature reviews, and educational content in the field of life sciences. Content Development: Developing compelling, informative, and accurate science-based articles, blogs, and instructional materials. Biology Teaching: Offering personalized tutoring in biology, focusing on concepts like genetics, microbiology, and molecular biology for students at all levels. Why Choose Me? Published researcher with expertise in cancer biology, drug resistance, and molecular mechanisms. Proficient in writing scientific and general content tailored to diverse audiences. Adept at breaking down complex topics into clear, easy-to-understand explanations. Detail-oriented, creative, and committed to delivering work that exceeds expectations. Whether you need a dedicated tutor to help you master biology or a professional writer to bring scientific content to life, I’m here to help. Let’s connect and create something amazing together!
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Publication Design
    Songwriting
    Biography Writing
    Cellular Biology
    Biology
    Biology Consultation
    Biochemistry
    Teaching English
    Biotechnology Regulation
    Biotechnology
    Professional Tone
    Proofreading
    Academic Editing
    Writing
    Content Writing
  • $4 hourly
    After working at ICMR as a research assistant I gained immense knowledge of Molecular biology and hands on experience of different techniqued in Biotechnology. After marriage I continued my carrier as a tutor for 2.5 years. Because of some personal circumstances I took a sabbatical of 2 years. Took some freelance projects of writing assignments and research papers during my sabbatical. In short I will like to introduce myself as a person who is multi talented with a science background and give 100% to complete the given job successfully on time.
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Biology
    Hindi to English Translation
    Microsoft Word
    Article Writing
    Biotechnology
    Molecular Biology
    Research Papers
    Scientific Research
    Biotechnology Regulation
    Microsoft Excel
  • $3 hourly
    I am a biotechnologist and a passionate researcher about studying and developing the knowledge and skills about how the environment and its surroundings behaves on the human beings. can be helpful in: Biological proofreading DNA and genomics research Drug discovery Scientific writings/ typing/ proofreading. Reports assessments
    vsuc_fltilesrefresh_TrophyIcon Biotechnology Regulatory Affairs
    Microsoft 365 Copilot
    Typing
    German
    English
    Scientific Literature Review
    Drug Discovery
    Biotechnology Regulation
    Biotechnology
    Biology
    Laboratory Equipment Skills
    Business
    Business Writing
    Proofreading
    Writing
    Academic Editing
  • Want to browse more freelancers?
    Sign up

How hiring on Upwork works

1. Post a job

Tell us what you need. Provide as many details as possible, but don’t worry about getting it perfect.

2. Talent comes to you

Get qualified proposals within 24 hours, and meet the candidates you’re excited about. Hire as soon as you’re ready.

3. Collaborate easily

Use Upwork to chat or video call, share files, and track project progress right from the app.

4. Payment simplified

Receive invoices and make payments through Upwork. Only pay for work you authorize.