Regulatory Affairs Officer

**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**: - Preparation and submission of EU Marketing Authorisation Applications (Module 1,2,3) for Initial MAA and LCM (via DCP, MRP and NP) - Monitor and maintain up-to-date knowledge of national and European guidelines/legislation. - Ensuring compliance with all regulatory processes including MHRA and HPRA - Management of artwork...

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...

Job Description:Relevant experience in regulatory package preparation, compilation and submission to Health Authorities in various markets with focus on EU countries.Working knowledge of EU regulatory procedures including adaptability to strict Health Authority and Sponsor timelines for completing submissionsKnowledge of EU country regulationsAble to...

**Job Description - Admission Affairs Executive** **About the company**: Britts Imperial Education Group is an Academic Centre and Education Partner to globally recognized British and European Universities that offer Undergraduate, Postgraduate and Doctoral programs to aspiring learners from across the globe. **Essential Roles and Responsibilities**: As an...

**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...

**POSITION: Experienced Compliance Officer (Non-Employee Contractor)** **COMPANY: Egan-Jones Rating Company** **LOCATION: Remote Work** **FIRM OVERVIEW** **POSITION** **Overview** Egan-Jones Ratings Company is seeking a full-time, experienced contractor to assist the Compliance Department with developing and implementing internal controls pertaining to...

**Job Title: Office Staff Assistant** **Company**: YOB Hotel Supplies and Hospitality Solutions **Location**: Siliguri, West Bengal **Key Responsibilities**: 2. Assist with sales activities, including preparing quotations, following up with clients, and processing orders. 3. Create and manage e-way bills for export shipments, ensuring compliance with...

**Description** **Medical Writer II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...

**Job Summary**: We are looking for a Compliance Officer who can support us part-time for conducting scheduled and unscheduled patient and professional audits and projects related to billing and payment integrity, workflow, and duties in order to ensure accurate and timely responses. Oversees, coordinates, and conducts audits on documentation, abstraction,...

**Job Summary**: We are looking for a Compliance Officer who can support us part-time for conducting scheduled and unscheduled patient and professional audits and projects related to billing and payment integrity, workflow, and duties in order to ensure accurate and timely responses. Oversees, coordinates, and conducts audits on documentation, abstraction,...

**Full job description** 1) Be proficient in English language 2) Write/edit breaking news stories and features 3) Be a self starter and be able to manage shifts 4) Be aware of current affairs 5) Be able to work in shifts and on weekends 6) Be willing to travel to office twice/thrice a week if based out of Mumbai 7) Be comfortable working on...

Job Overview Engage in peer-to-peer scientific exchange with ability to understand, interpret, communicate complex scientific data and information effectively to KOLs/HCPs Essential Functions - Engage in peer-to-peer scientific exchange with ability to understand, interpret, communicate complex scientific data and information effectively to KOLs/HCPs -...

**Overview**: As a Procurement Officer, you will play a pivotal role in ensuring the smooth and efficient operation of our organization's procurement process. You will be responsible for sourcing, purchasing, and managing the supply of goods and services essential for our operations. Your keen attention to detail, negotiation skills, and ability to maintain...

Essential Functions - Ensures standard operating procedures (SOPs) are appropriately managed and maintained to adhere to regulatory guidelines and corporate quality practices. Maintains SOP documentation and sends appropriate notifications when SOPs are not followed. **Qualifications**: - Computer skills (EXEL, Word, Office) - English literate

**Technical Skills Required**: - Lifecycle maintenance experience - Providing support during external and unannounced audits. - Responding to internal requests for technical and/or regulatory information. - Preparation and submission of Technical/Site Transfer Applications - Assisting with the preparation of Marketing Authorisation Applications - Monitor...

Job description Urgently scouting for smart, honest Field Investigation officers (80% field work) for Madhya Pradesh especially Indore, Bhopal, Jabalpur, Gwalior, Ujjain, Satna, Ratlam, surrounding areas & Bihar with experience in Health insurance, PA, life insurance claims investigations. Should be able to produce integrity & experience certificates from...

**Job Title: Medical Writer (1-2 Years Experience)** **Responsibilities**: - Create precise medical content following scientific and regulatory guidelines. - Conduct thorough research on medical topics. - Prepare regulatory documents like clinical study reports and protocols. - Assist in manuscript development for scientific journals. - Collaborate with...

The Pharmacovigilance Information Specialist (PVIS) for GPIO (Global Pharmacovigilance Information Office) will research, review, and maintain information related to expedited and periodic safety reporting requirements for both clinical trial studies and post market projects. The PVIS works to ensure company and client compliance with relevant national and...

Key Responsibilities: - Lead financial strategy and planning for domestic and global operations. - Oversee financial reporting, budgeting, and forecasting. - Manage international finance teams and operations. - Drive profitability and cost efficiency initiatives. - Ensure compliance with regulatory requirements across the globe. **Requirements**: -...