Ren957 Principal Regulatory Affairs Specialist | [O167]

REN957 Principal Regulatory Affairs Specialist (Clinical Research field:CTA):Start Now:(...)REN957 Principal Regulatory Affairs Specialist (Clinical Research field:CTA):Start Now:(...) REN957 Principal Regulatory Affairs Specialist (Clinical Research field:CTA):Start Now:(...) REN957 Principal Regulatory Affairs Specialist (Clinical Research field:CTA):Start Now:(...)REN957 Principal Regulatory Affairs Specialist (Clinical Research field:CTA):Start Now:(...)
REN957 Principal Regulatory Affairs Specialist (Clinical Research field:CTA):Start Now:(...)REN957 Principal Regulatory Affairs Specialist (Clinical Research field:CTA):Start Now:(...)domainPharmaceutical Product Development location_onLimaVeröffentlichung:21.11.22Branche:AndereREN957 Principal Regulatory Affairs Specialist (Clinical Research field:CTA):Start Now:(...)domainPharmaceutical Product Development location_onLimaWe are on the lookout for a capable Principal Regulatory Affairs Specialist (Clinical Research field:CTA) to join our stellar team at Pharmaceutical Product Development in Lima, Lima.Growing your career as a Full Time Principal Regulatory Affairs Specialist (Clinical Research field:CTA) is an awesome opportunity to develop productive skills.If you are strong in communication, decision:CTA) at Pharmaceutical Product Development today**Job Description**:Principal Regulatory Affairs SpecialistWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services - thousands of employees in locations worldwide connected by tenacity and passion for our purpose:to improve health. You will be joininga truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life:saving therapies to patients.If you're a strategic thinker,
planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - and help get life:changing therapies to patients faster.Currently is seeking a Principal Regulatory Affairs Specialist to join our growing Regulatory Affairs department. This is a fantastic opportunity to further your regulatory career and develop your expertise in this field.In this role you will be a pivotal team member with ideally with regulatory experience. You will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence,
guidance and regulatory expertise for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision and marketing of these services.You'll work with the Regulatory Affairs management to perform the day to day operational aspects of the department such as:preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature.
You will also act as prime interface with the sponsors of assigned projects.The following skills are required to be successful in this position:Experience developing regulatory strategies globallyExperience and knowledge of bid defence meetingsExperience leading global regulatory projectsClient facing experienceJob QualificationWhat the role requires you to have:Bachelors degree or advanced degree preferred, or equival