Company Description Vaancure Biologics is a biopharmaceutical company focused on enhancing global health through innovative and high-quality therapeutics. Its state-of-the-art manufacturing facilities are accredited by leading regulatory authorities including USFDA, UK MHRA, Australian TGA, PIC/S, and WHO GMP, demonstrating a strong commitment to quality, safety, and efficacy.

The company offers a diverse portfolio of over 500 products, ranging from tablets, capsules, eye and ear care liquids, ointments, injectables, medical devices, and cosmeceuticals. In addition to manufacturing, Vaancure Biologics provides business consulting, regulatory services, and turnkey solutions to clients worldwide. Guided by a customer-centric approach, the organization is recognized for timely delivery, affordable pricing, and trusted long-term partnerships.

Role Description This is a part-time, remote role for a Freelancer specializing in Regulatory Affairs for Medical Devices and Pharmaceuticals at Vaancure Biologics. The freelance professional will support regulatory strategy, compile and review regulatory dossiers, and prepare submissions to relevant authorities for product approvals and variations.

Daily tasks include interpreting and applying global regulatory requirements, reviewing technical documentation, labeling, and promotional materials for compliance, and advising internal and client teams on regulatory pathways. The role involves coordinating with cross-functional stakeholders such as quality assurance, manufacturing,



and clinical teams to ensure documentation accuracy and readiness for audits or inspections. The freelancer will also monitor regulatory changes, maintain up-to-date regulatory intelligence, and contribute to process improvements and best practices.

Qualifications

- Strong knowledge of global regulatory frameworks for pharmaceuticals, biologics, and medical devices (e.g., USFDA, EMA, MHRA, TGA, WHO GMP) and experience preparing and managing regulatory submissions.
- Ability to analyze and interpret technical and scientific data, including CMC documentation, product dossiers, and clinical or performance data, and translate requirements into actionable regulatory strategies.
- Experience with quality and compliance activities such as reviewing labeling, IFUs, promotional materials, and change controls to ensure alignment with regulatory and GMP standards.
- Proficiency in documentation management, including writing and editing regulatory documents, SOPs, technical files, and maintaining organized records and trackers.
- Excellent communication and stakeholder management skills, with the ability to collaborate remotely with cross-functional teams and external clients.
- Detail-oriented, self-directed work style with robust time management skills suitable for part-time, remote freelance engagements.
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field; professional certification in Regulatory Affairs is an advantage.
- Prior experience in a pharmaceutical, biologics, or medical device company or consultancy; familiarity with

📌 Freelancer - Regulatory Affairs, Medical Device & Pharmaceuticals (India)
🏢 Vaancure Biologics
📍 India