Senior Manager Regulatory Affairs

Overview

GandL have an opportunity for a senior Regulatory professional with a strong background in CMC and biotechnology. Our UK team, based in West London, has a number of projects with requirements in the coming months. Our projects are diverse and we are considering all regulatory talent for upcoming openings in biotechnology and pharmaceutical development and approved products.As a GandL consultant , you will be working with a variety of clients, and duties may include the following:Responsibilities

Developing submission strategies and planning for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.Evaluating change controls and providing regulatory assessments to classify quality changes in production and quality control.Supporting client project teams in the preparation of the CMC sections of submission content to facilitate approvals and continued compliance.Reviewing key study reports (e.g., process validation, stability studies, analytical method validation) to ensure regulatory compliance.Developing and maintaining high quality, realistic Chemistry, Manufacturing and Control (CMC) plans for products in development.CMC authoring of Module 2.3 and Module 3 sections of the CTD dossier.Maintaining positive liaison with internal and external contacts, including clients, regulatory agencies, and related institutions.Attending formal interactions (face-to-face meetings, teleconferences, etc.) with clients and possibly government agencies, building positive working relationships with clients.Identifying gaps and risks in the CMC plans and developing solutions to increase efficiency and minimize timelines.Assisting in the development of assessments and strategic regulatory plans for client product development programs.Reviewing CMC sections of BLA submissions and preparing gap analyses detailing requirements for submission to different jurisdictions.Participating in project teams and advising other departments on CMC regulatory issues and strategies, including manufacturing, supply chain, quality control, quality assurance, and other regulatory entities.Person specification

Around 5-10 years working knowledge of CMC regulatory affairs, including a minimum of 3 years working with biotechnology products.Experience in authoring technical / CMC parts of regulatory documents.Knowledge of Health Canada, FDA, EMA and ICH practices, regulations and guidelines and their implementation into regulatory filings; integration of CMC data into regulatory and quality documents.Ability to maintain a high level of accuracy and attention to detail.Problem solving, judgment and decision-making skills to seek creative solutions to issues surrounding on-time, on-budget and high-quality project outcomes.Excellent planning, organization, interpersonal, time and change management skills.Working knowledge of RIM systems including Veeva Vault.Proficiency in MS-Office applications including Word, Excel and PowerPoint.How to apply

Please send your CV to

talent@gandlscientific.com

today.GandL Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and believe that an individual’s background should play no part in the recruitment and selection ..... full job details .....