Senior Regulatory Affairs Associate

**Responsibilities**: - Contribute to regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions. - To contribute to the production of client administrative documents to be included in regulatory submissions -...

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...

**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...

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...

**Project** Description**: Role is for an experienced Regulatory SME (Project Manager/Analyst/Tester/Developer) to join the DevOps or Change Management Function with this Global Financial Institution. The role will also require working with the key stakeholders to help determine the priorities of the development/process update required and ensuring that...

**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...

(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...

We Are HIRING! **Associate, Communications** Who can apply? Graduate in communication, mass media, marketing, journalism or a related field with minimum of 1-2 years of experience in communications, content creation, social media management, public relations or related roles. **Location**: - Flexible - Anywhere in India **Work Type - **Hybrid (Virtual...

We are looking for experienced Indian clinical trial disclosure associates to join our dynamic, collaborative team to engage with biopharmaceutical clients to prepare and maintain clinical trial registry postings across global registries. This a full-time, remote opportunity. **About Us** Kateric (a Propharma group company) is a strategic partner for...

We are looking to recruit a Junior Pharmacovigilance Associate reporting to the Pharmacovigilance Manager **What will you be doing?** As the Junior Pharmacovigilance Associate, you will be responsible for a variety of different tasks including: - Play an active role within the Pharmacovigilance Team, accountable for monitoring and managing all aspects of...

**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 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 -...

Job Title: B2B Sales Executive - Edtech As a B2B Sales Executive - Edtech at UptoSkills, you will play a pivotal role in bridging the gap between education and industry by facilitating skill development initiatives and fostering meaningful connections between college students and potential employers. Your responsibilities will include but are not limited...

Accountable for PSR processes deployment. - Coordinate PSR preparation activities. Liaise with internal stakeholders and Shared INN PSR management - Provides Global PSR format training to new and contributors, provides mentorship for new PREs; - SME in inspections, internal and partner audits to communicate PSR processes and expectations as defined in...

Responsibilities:Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.Proactively...

**Description** **Associate Director, Biostatistics** 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...

**Description** **Quality Assurance Associate** 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...

Key Accountabilities:Project Management: Ability to fill Statistical Programming Lead role on projects -Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. -Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.-Monitor project resourcing, project...

Job Purpose: Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United...