Regulatory Affairs Associate

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

Senior Regulatory Affairs AssociateAround 4-8 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresContribute to preparation...

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...

(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...

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...

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 -...

**Description** **Principal Biostatistician** 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 patient...

Management/coordination/oversight of QA compliance GxP activities in a specific geographical and/or functional/specialist area :Lead and work independently and as part of the QA team Act as expert GxP consultant in relevant area to groups within the Parexel organization and Parexel clients. Promote compliance within the company and represent QA, as required....

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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** **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...

**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...

**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...