Regulatory Affairs Associate

Regulatory Affairs Associate Manager Location: Remote Duration: 7 months RESPONSIBILITES: - Validate product composition, ingredient lists, develop nutritionals and advise on/approve regulated claims for compliance under US laws and regulations - Participate in validation of marketing campaigns and review of associated materials - Approve packaging...

**Responsibilities**: - Contribute to regulatory activities such as pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions. - Document and track regulatory submissions and regulatory authority approval. - Provide on-going regulatory support to the Regulatory Affairs Specialist and to project teams to...

**Regulatory Affairs Associate** - Around 2 to 4 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. - Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory...

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...

Regulatory Affairs Consultant.8+ years' experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute...

Hyderabad **EMAIL** I **Career opportunity** **Consultant - Medical Device Regulatory and Clinical Affairs** **Project Associate - Remote, India** Diagnostics compliance with international regulatory requirements. We serve clients with hands-on support for compliance with applicable regulatory requirements of our clients’ target markets. Our...

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...

**Job Summary**: The Pharmacovigilance Associate plays a key role in monitoring and ensuring the safety of pharmaceutical products throughout their lifecycle. Working within a multidisciplinary team, the associate is responsible for the collection, assessment, and reporting of adverse events and safety information associated with medicinal products. This...

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...

Key Accountabilities:Project Execution:Works effectively within a team environment but may work independently delivering services within their area of competenceWorks within broad project guidelines as directed by the project lead and/or technical SMEsTakes initiative to prioritize work to achieve specified project outcomes while confirming alignment with...

Responsibilities: - Receive and process adverse event reports from various sources, including healthcare professionals, consumers, and clinical trials. - Conduct initial assessment of reported adverse events to determine seriousness, expectedness, and causality. - Enter adverse event data into safety databases accurately and in a timely manner, ensuring...

Scribble Straight Content Writing Agency Join us at **Legal Internship Opportunity (Online): Gain Valuable Experience and Build Your Future!** Are you a passionate law student looking to kickstart your legal career? Look no further! Our prestigious company is excited to announce an incredible opportunity for a **Legal Intern** (online) to join our team...

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 -...

We are seeking a dynamic and motivated Sales Associate to join our team, specializing in credit card sales. This is a remote/work from home position, offering flexibility and the opportunity to excel in a challenging and rewarding sales environment. **Responsibilities**: - Educate customers on the features and benefits of our credit card products,...

**Job Title: Chief Financial Officer (CFO)** **About Brewed Ventures**: Brewed Ventures Private Limited is a dynamic and innovative startup in the Tea industry, dedicated to revolutionising the way people experience their favourite daily brew. Committed to quality, sustainability, and creativity, we specialise in 100% Pure Farm to Cup tea products sourced...

**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...

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and...

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North 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 quality documents; - Implements process and quality document changes when regulatory requirements change or process...

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...