Job Details

At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.**Location/Division Specific Information**Pharmaceutical Services Group / Regulatory Services/ Greenville, NC**Discover Impactful Work:**The role provides activities supporting regulatory aspects of customer projects in accordance with the Regulatory Services menu. The successful candidate will perform activities and collaborate to assure company/site compliance with applicable regulations including: establishment registration, drug listing, drug master files and site master files.**day in the Life:**+ Contribute to authoring, review and provide comments for Chemistry Manufacturing and Control (CMC) CTD documents, including Investigational Applications (IND, CTX), Marketing Applications (NDA, NDS, MAA, BLA), and post-approval lifecycle dossiers, per the North American Regulatory Affairs Services Menu+ Collaborate and coordinate with SMEs to support the authoring and review activities of CMC CTD documents+ Prepare company regulatory submissions (e.g. site master files, drug master files)+ Support key company projects in the North America region such as new facilities, new strategic customers+ Able to provide moderate to complex regulatory strategic advice for internal customers and clients+ Track NA Regulatory Services metrics for self and assist with collation and reporting out for North American network+ Contribute to regulatory intelligence surveillance and communication to the network**Education**Bachelor's degree in a scientific or related field is required.**Experience**At least three (3) to five (5) years of regulatory experience in the pharmaceutical industry, preferably with experience in sterile products.**Equivalency** : Equivalent combinations of education, training and relevant work experience may be considered.**Knowledge, Skills, Abilities**+ Solid understanding of regional regulatory requirements and the global regulatory environment.+ Proficient in technical writing and knowledge in Chemistry Manufacturing and Controls (CMC) CTD documents, Investigational Applications (IND, CTX), Marketing Applications (NDA, NDS, MAA, BLA), and post-approval lifecycle dossiers. Knowledge of sterile drug product manufacturing and the production of biological products are an asset.+ Demonstrated ability to evaluate and resolve moderately complex regulatory and technical issues due to broad based knowledge of pharmaceutical manufacturing and related regulatory requirements.+ Highly effective verbal and written communication skills in English.+ Strong negotiation and influencing skills with internal partners, clients and regulatory bodies.+ Collaborative teammate with strong social skills, who cultivates open communication and facilitates mutual understanding and collaboration between all partners, internal and external.+ Strong computer knowledge including Microsoft Suite.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valuedThermo 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.