Regulatory Affairs Associate

**Job Title**:Pharmaceutical Regulatory Affairs Executive **(Intern)** **Location**: Pune, India **Duration**: 9 months (Advanced Certification) + 3 months (On the Job Internship) **Job Summary**: **Key Responsibilities**: 1. Attend classes on weekends (Saturdays and Sundays) 2. Complete coursework, assignments, and projects 3. Participate in...

We are looking for an Regulatory Publisher to develop new challenging projects which would include the following responsibilities: - Perform quality control procedures to ensure completion, correctness, navigability, and adherence to regulatory eCTD guidelines. - Perform document management tasks and post-submission activities including file transfer,...

**Required education**: Degree in relevant life science discipline **Required Experience**: 2-4 years relevant experience **Required Technical Skills**: - Lifecycle maintenance experience - Providing support during external and unannounced audits. - Responding to internal requests for technical and/or regulatory information. - Preparation and submission...

**Responsibilities and duties** **Requirements**: - Master’s Degree in Biological Science, applied biology or related field. - 3+ years’ practical experience with licenses and certification legal procedures. - Extensive background in data mining and analysis. - Able to understand various botanical and pharmacological common methods and specific...

The Regulatory Project Assistant (RPA) is responsible for providing project administrative support to the regulatory project team members (regulatory affairs, eTMF operations). The RPA also supports activities within the regulatory website Clinical Trial Information System (CTIS) ensuring completeness and timely entry of information for EU submissions. The...

**Responsibilities**: - To contribute to the production of client administrative documents and reports to be included in regulatory submissions - Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements - LCM, Systems Management and Administration - Document and track regulatory submissions and regulatory...

(India) Looking for experienced regulatory writers **As we are expanding our team, we are thrilled to announce that we are looking for experienced Indian regulatory writers to join our dynamic, collaborative team to engage with biopharmaceutical clients and prepare clinical and safety regulatory documents. This is a full-time, remote, salaried...

Medical Expert RoleWe are seeking a skilled Medical Expert to collaborate with Key Opinion Leaders, build relationships with leading specialists, and tailor medical activities accordingly.The successful candidate will contribute to the Medical Affairs Plan, including budget monitoring, by providing strategic input on medical programs, product positioning,...

The primary duty of a Drug Safety Associate involves the ongoing monitoring and evaluation of adverse effects and safety concerns associated with drugs and medical products following market approval. As a Drug Safety Associate, your responsibilities will include monitoring, assessing, and reporting adverse events related to pharmaceutical products. You will...

Premier Research is looking for a Site Start Up Associate 1 to join the SSU Team in India. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are...