Regulatory Affairs Specialist

Company DescriptionCLAPS Industries Pvt Ltd. is a global pharmaceutical company that was founded by a visionary team of highly successful individuals in the field of pharmaceuticals. The company is dedicated to providing high-quality healthcare products and services globally. CLAPS is expanding rapidly through product diversification, strategic...

**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 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...

BIOTEK is a global medical device company focusing on new product development in the most advanced Orthopaedic sector: SPORTS MEDICINE. With presence on all six continents worldwide, the growth and demand for our products around the globe is unprecedented.As a Regulatory Affairs Sr. Coordinator, you'll play a crucial role in regulatory submissions for...

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.

We are Hiring Regulatory Affairs Specialist For Medical Devices (OrthopedicImplants And Instruments) Role & Responsibilities:1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA.2. Work On Technical Master File.3. Work On CERs (Clinical Evaluation Report) As Per EU MDR.4. Work on Design & Development and Risk Management Files as per...

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...

We Are Hiring: Senior Research Associate – Regulatory AffairsAre you a seasoned Regulatory Affairs professional with a passion for global impact?We're looking for aSenior Research Associate – Regulatory Affairswith strong expertise inEuropean, Asian, and EU regulatory marketsto join our team.Key Requirements: Hands-on experience withEU & Asian regulatory...

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 ResponsibilitiesResponsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities.Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc.Preparation of pharmaceutical/quality part (all forms)...