Regulatory Affairs Specialist - CMC

Position Overview

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

PPD, the Clinical Research Group of Thermo Fisher Scientific is recruiting for a Regulatory Affairs Specialist with a focus on CMC.

Responsibilities

In this role, your primary responsibilities will be to:

• Provide high-quality client support and interface in terms of the provision of strategic regulatory CMC intelligence, guidance, and regulatory expertise for product development from preclinical through registration and product lifecycle management.
• Author CMC documentation to support regulatory filings, e.g., EU IMPDs, simplified IMPDs, US IND Module 3, and Canadian QOS.
• Apply in-depth understanding of regulatory guidance and regulations to the preparation of CMC documents and sections for a variety of submissions or other documents, as required.
• Review CMC documents and ancillary documents and reports for completeness and accuracy and for compliance with regulations.
• Interface with other regulatory departments within PPD Regulatory Affairs and represent the CMC function on multidisciplinary project teams.
• Prepare CMC sections of Regulatory Authority scientific advice briefing books, e.g., EMA, UK MHRA, and US FDA.
• Collaborate with project team stakeholders to manage and coordinate the authoring, review, and finalization of CMC documents in accordance with submission timelines, keeping all stakeholders, including clients, informed of progress.
• Research and utilize information to ensure high-quality and regulatory-compliant strategies and submissions.
• Coordinate the timely and accurate assembly of responses to inquiries from Regulatory Authorities on CMC content of regulatory submissions.
• Identify project issues and contribute to the development of alternate strategies as required.

Requirements

Education and Experience

• Ideally, candidates will have a degree (or equivalent) and higher degree, e.g., in Chemistry, Biochemistry/Molecular Biology, and Pharmaceutical Sciences.
• Ideally, some prior regulatory affairs experience with a CMC background.
• Some knowledge of ICH and other global regulatory guidelines.
• Some knowledge of CMC Regulatory requirements, guidelines, procedures, and policies relating to the registration and manufacturing of pharmaceutical products.
• Awareness of the contents of clinical trial applications and marketing authorisation applications, preferred.
• Ideally, some prior experience authoring CMC documents to support filings of CTAs and MAAs for NCEs, biopharmaceuticals, and Advanced Therapy Medicinal Products.
• Knowledge of biopharmaceutical and/or pharmaceutical development, testing, or manufacturing preferred.

Knowledge, Skills, and Abilities

• English language proficiency (written and spoken), as well as local language where applicable.
• Experienced with Microsoft Office applications, e.g., Word, Excel, Visio, PowerPoint.
• Microsoft Word authoring and formatting skills are essential for this role.
• Effective oral and written communication skills.
• Good organizational and planning skills.
• Effective negotiation skills.
• Ability to work on own initiative and plan and prioritize workload to meet client deadlines.
• Proven ability to work effectively in a team environment.
• Some knowledge.

Employment Details

• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Location Type: [Information not provided]
• Salary: [Information not provided]
• Environmental Conditions: Office