Regulatory Affairs Executive

**Vivanza Biosciences Limited** is seeking a highly motivated and detail-oriented professional to join our team as a **Regulatory Affairs Executive** in Ahmedabad, Gujarat. This role is ideal for an individual with foundational experience in the pharmaceutical industry who is keen to grow their career in regulatory compliance and submissions for global...

We are hiring Regulatory Affairs (RA) Executive / Manager for a leading Pharma company in Ahmedabad. The candidate will be responsible for dossier preparation, product registration, regulatory submissions, and maintaining compliance with international guidelines (ROW / LATAM / Africa). Must have hands-on experience in RA documentation for pharma...

Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

Company DescriptionCLAPS Industries Private Limited is a global pharmaceutical company, founded by a visionary team of seasoned professionals from the pharmaceutical and healthcare sectors. Focused on delivering high-quality healthcare products and services worldwide, CLAPS empowers accessibility through affordable and effective medications. The company has...

Company DescriptionJaidev Pharma Placement is a renowned recruitment agency with a proven track record of over two decades in Pharmaceutical Sales, hiring, recruitment, and training across India. We specialize in providing tailored human resources solutions to help organizations achieve their goals while supporting employees' career growth. Our expertise...

Seeking a Regulatory Affairs professional (5–12 yrs exp, US FDA focus) to manage product approvals, ensure compliance, and liaise with regulatory bodies. B.Pharm/M.Pharm required.

Job Responsibility: Prepare, compile, and review eCTD dossiers for submissions (e.g., ANDA/NDA /MAA/ANDS).Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation.Submit applications to US FDA, HC, EMA, and other authorities in compliance with regional requirements.Compile and validate submissions using tools...

Roles and ResponsibilitiesPrepare dossiers for US FDA, including CTD format.Ensure regulatory compliance with RA requirements.Manage parenteral products' dossier preparation and submission to regulatory authorities.Coordinate with cross-functional teams for injectable product development and registration.Track regulatory updates and maintain records in...

Regulatory Affairs and Quality Assurance InternRoles & Responsibilities:Conduct research on regulations, new topics, and global guidelines.Assist in preparing regulatory documents, country registration files, and NB application forms.Support creation and maintenance of regulatory databases.Prepare QMS documents (SOPs, forms, templates) and assist in...

We are HiringRegulatory Affairs Specialist For Medical Devices(OrthopedicImplants And Instruments)Role & Responsibilities:Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA.Work On Technical Master File.Work On CERs (Clinical Evaluation Report) As Per EU MDR.Work on Design & Development and Risk Management Files as per EU MDR.Have...