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Senior Regulatory Affairs CMC Manager - Paddington, London (Hybrid)

Contract: Permanent Career Opportunity

Closing Date: 26/07/24

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Independently provide strategic and operational global CMC regulatory direction and documentation for projects/products covering development, registration, and approval/post-approval activities.

Make informed regulatory decisions, balancing patient and business risks and benefits leading to timely Health Authority approvals.

The Role

Major Accountabilities

  • Formulate, lead, and drive global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance
  • Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
  • Identify the required documentation and any content, quality, and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends, and guidelines.
  • Ensure technical congruency and regulatory compliance, meeting agreed-upon timelines and e-publishing requirements.
  • Proactively communicate CMC regulatory strategies, risks, and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams as appropriate.
  • Lead, prepare, and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate as appropriate.
  • Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals, and risk mitigation plans. Establish and maintain a single point of contact with FDA.
  • Represent the department on due diligence teams for in-licensing and divestment opportunities.

Key Performance Indicators (KPIs)

  • Produce high-quality strategic project documentation and presentations (e.g., project plans, documentation, Risk Management Assessments, lessons learned, etc.); no late changes in strategy due to inadequate prior evaluation.
  • Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers, or variations due to late or inadequate submission documentation on matters within RA CMC control.
  • Deliver reliable, timely, and accurate information/communication about project-specific issues within own department and to key stakeholders; changes in project status communicated as required.
  • RA CMC regulatory documentation follows client guidelines and meets regulatory guidelines.
  • Provide high-quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems.
  • Build and maintain collaborative partnerships with stakeholders.

Requirements

  • Minimum 5 years in regulatory preferred, and/or experience in the pharmaceutical industry.
  • Working knowledge/experience in regulatory submission and approval processes.
  • Working knowledge of chemistry/biotechnology, analytics, or pharmaceutical technology. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of product development and life cycle is desirable.
  • Demonstrated track record of successfully working in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.
  • Ability to work independently and successfully with global project teams and prioritize activities considering timelines and workload.
  • Effective planning, organizational, and interpersonal skills.
  • Computer/IT systems literacy
How to Apply

For further details, please send your CV to: talent@gandlhealth.com

G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.

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