Job Description
When you join us at Thermo Fisher Scientific, you'll be part of a hard-working and driven team that shares your passion for exploration and discovery. With revenues of approximately $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world. Ranked #69 on the 2023 Fortune 500 list, you'll discover endless opportunities to grow a rewarding career as part of the world leader in serving science.
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
How will you make an impact?
Position Overview:
The role is responsible for leading site regulatory activities related to the development and commercial products at the High Point, NC site. This role involves writing and reviewing CMC documents in compliance with pharmaceutical regulatory requirements, including US FDA 21 CFR, ICH guidelines, and GMP and publishing and submitting these in eCTD format to the FDA. Additionally, this position requires representation and advisory support to the Regulatory Affairs (RA) team in R&D project teams, providing expertise on registration files, facilitating regulatory problem-solving with clients, interacting with the FDA as the US agent, and supporting the setup of bioequivalence studies.
What will you do?
Key Responsibilities:
Additional Responsibilities:
Competencies:
Knowledge and Experience:
Note: This job description is based on the provided information and may not cover all aspects of the role.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement. We offer competitive compensation, annual incentive plan bonus, healthcare, 401k match, and a range of employee benefits! To learn more about our total rewards package visit https://jobs.thermofisher.com/global/en/total-rewards.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
Benefits & Total Rewards | Thermo Fisher Scientific
We strive to bring together and develop extraordinary colleagues who share our passion for making significant contributions to the world.
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