Regulatory Affairs Associate

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...

**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 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...

**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...

**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...

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...

**Description** **Principal Statistical Programmer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of...

**Description** **Principal Medical Writer** 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...

**Department** Just about anyone seeking published literature to answer research questions can type terms into a database and then hope to make sense of the information retrieved. But when done without the right knowledge, skills, and experience, such an exercise risks answers that are biased, confusing, incomplete, or wholly incorrect. This helps explain...

**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...

KLDiscovery, a leading global provider of electronic discovery, information governance and data recovery services, is currently seeking a Commercial Counsel to support our corporate business systems across the 1,600-person global company. The Commercial Lawyer will work closely with the General Counsel to advise on risk, compliance and legal issues for all...

**About Delta Capita** Delta Capita is a global Managed Service, technology solution and consulting provider, with a unique combination of experience in financial services and capability in technology innovation. Our vision is to ‘Reinvent the Financial Services Value Chain’, and we provide a Business Operating Platform-as-a-Service. We are a trusted...

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...