WFH Regulatory Affairs Job For Life Science at Thermo Fisher Scientific, Apply Online
Reg Affairs Manager, CMC – FSP
Remote, India
R-01294778
Job Type: Full-time
Category: Clinical Research
Remote: Fully Remote
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office
Job Description
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.
Our Global Regulatory FSP team is looking to hire:
CMC Regulatory Manager
Purpose of the Mission
The CMC Regulatory Manager is involved in the company’s worldwide post-approval regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) for biological products.
Primary Tasks & Responsibilities
- Prepares submission strategy and planning for post-approval CMC activities (Variations, Renewals, Market Expansions, Annual Reports).
- Assesses change controls and provides regulatory assessments regarding the classifications of quality changes in production and quality control.
- Reviews study reports (process validation, stability studies, analytical method validation) provided by the quality control and production departments to ensure compliance with regulatory requirements.
- Ensures coordination of submission preparation with the departments involved: manufacturing, supply chain, quality control, quality assurance, and other regulatory departments and local companies.
- Writes and/or reviews submission content to ensure alignment with regulatory requirements (variations, responses to health authority queries).
- Manages projects within all client’s/GRA Regulatory Information Management systems (maintenance of worldwide submissions).
- Identifies, escalates, and mitigates risks related to regulatory procedures and activities.
Experience, Knowledge & Soft Skill Requirements
Knowledge/Skills:
- Exhibits a very good understanding of CMC and post-approval regulatory requirements.
- Knowledge of regulatory procedures, systems, and guidelines (quality control, stability, process validation, comparability studies).
- Excellent level of spoken and written English.
- Good level of spoken and written local language (depending on the location: French, Italian, or German).
- Knowledge of biological processes.
- Knowledge of Qualification/Validation principles.
Soft Skills:
- Manages own time to meet agreed milestones.
- Good communication skills, able to work in a multicultural and multidisciplinary environment.
- Strong writing and analytical skills, with an eye for detail.
- Creative and critical thinking mindset.
- Team spirit, flexibility, accountability, and well-organized.
Experience
- Experience in regulatory affairs (related to technical/CMC/quality) in the pharmaceutical industry.
- Experience in writing CMC (technical) parts of regulatory documents (registration files or variations).
- Experience working in validation, quality assurance, or production in the pharmaceutical industry, with experience preparing regulatory documentation.
Education, Methodology & Certification Requirements
- University-level degree (Life Sciences background preferred) or equivalent by experience.
- Proficiency in Word, PowerPoint, Excel; experience with Veeva Vault is valued.
Language Proficiency Requirements
- English: Fluent
- French, German, or Italian: Depending on location
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