Thermo Fisher Scientific Regulatory Affairs Manager Job, Apply Now!
Job Overview
Thermo Fisher Scientific is seeking a CMC Regulatory Manager (Remote, India) to support post-approval CMC activities and ensure regulatory compliance in the pharmaceutical industry. This role involves regulatory strategy planning, change control assessments, and submission management within a global clinical research environment. If you have regulatory affairs experience and a life sciences degree, join us in driving innovation and improving global health.
About Thermo Fisher Scientific
Thermo Fisher Scientific is a leading global contract research organization dedicated to bringing life-changing therapies to market. Our Clinical Research team plays a crucial role in clinical trials conducted worldwide, focusing on developing drugs to address significant health challenges. Join us in our mission to make the world healthier, cleaner, and safer through cutting-edge research and innovation.
Location: Remote, India
Primary Tasks & Responsibilities of CMC Regulatory Affairs Manager
- Prepare submission strategy and planning for post approval CMC activities.
- Assess change controls and provide regulatory assessments on quality changes.
- Review study reports to ensure compliance with regulatory requirements.
- Coordinate submission preparation with various departments.
- Manage projects within the regulatory information management systems.
- Identify, escalate, and mitigate risks related to regulatory procedures.
Experience, Knowledge & Soft Skill Requirements
- Experience in regulatory affairs in the pharmaceutical industry.
- Knowledge of CMC and post approval regulatory requirements.
- Excellent communication and analytical skills.
- Ability to work in a multicultural environment with a team spirit.
Education, Methodology & Certification Requirements
- University level degree in Life Sciences or equivalent.
- Experience with Word, PowerPoint, Excel, and Veeva Vault is a plus.
- Language Proficiency: English Fluent, additional language (French, German, or Italian) based on location.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer, promoting diversity and inclusion in the workplace.
Keywords: Thermo Fisher Scientific, Regulatory Affairs Manager, CMC, FSP, Clinical Research, Pharmaceutical Industry, Remote Job, Regulatory Requirements. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo
