Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!

Job description

Responsibilities

Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions.
Review and evaluate technical and scientific data and reports required for submission in support of company's products.
This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.
The incumbent will perform other duties assigned.
Track of status and progress of regulatory documentation,
Review, edit and proofread regulatory documentation.
Assist in preparation and review of labelling, SOP s, and other departmental documents.
Compile under supervision regulatory documents for submission.
Participate as an active team member of project teams as required.
Compile and prepare responses to regulatory authorities' questions.
Maintain regulatory files in a format consistent with requirements.
Maintain awareness of regulatory requirements May be responsible for a specific product portfolio in the region to perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Requirements:

Bachelor s degree or country equivalent in pharmacy or related scientific discipline with 0-2 years regulatory experience, preferably within a healthcare environment.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Scientific knowledge Written and verbal communication skills.
Systems skills (e.g. word processing, spreadsheets, databases, online research), Proofreading and editing skills.
Ability to contribute to multiple projects from a regulatory affairs perspective.
Ability to multitask and prioritize Include the education and experience that is necessary to perform the job satisfactorily.

Required profile