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...

**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...

Leading Global Cosmetics Consumer Products, Personal Care / Pharmaceutical corporation has an immediate need for an experienced Regulatory Affairs Associate. This is an excellent opportunity to join one of the world’s most respected and trusted companies. **Responsibilities**: - Review and respond to project team cross functional partners to provide...

Responsibilities In the context of a project for one of our top Pharma client, we’re looking for 2 talented Regulatory Affairs Officer to lead the following missions, and much more! Compile, or supervise the compilation of regulatory dossiers Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for...

**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...

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...

**MAIN RESPONSIBILITIES**: Provide technical support (internally and during meetings with prospects) and content for the preparation of proposals Prepare or review CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files). Define document writing strategies. Define positions for variation folders. Assess the compliance of...

**Company Overview**: **IJCP Group**, a pioneer of medical journalism in India, was founded in 1990 with the primary objective to facilitate medical professionals and healthcare providers with the current advancements and keep them abreast with the recent and upcoming trends in the medical field. Kicking off from the medical journal The Indian Journal of...

CTA Officer 621 In the context of a brand new project, we are looking for a consultant to join us asap on the following missions: **Responsibilities**: Responsible for overall planning and execution of regulatory and ethics submissions for assigned projects/countries (all regions especially Europe)/sites, which may include completion of submissions or...