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Regulatory Affairs Specialist - Houston, United States - Brenntag Specialities
Description
Our team inHouston
currently has an opening for a
Regulatory Affairs Specialist – Pharma
YOUR ROLE & RESPONSIBILITIES
Supporting the regional Pharma division Sales Team on topics including regulatory, legal, compliance, quality and product safety.
Completion of technical and regulatory information requests from customers within the pharmaceutical industry (questionnaires, supply chain agreements, QAA's & TA's) in and English.
Contribute as part of team to maintenance of EMEA document management system to keep product and supplier information up to date.
Request product and supplier information directly from manufacturers and indirectly via other internal channels.Process Change Control Notifications.
Maintain customer specific information such as completed questionnaires, supply chain agreements, QAA's, TA's in the designated database.
Creation and ongoing update of product regulatory information in standardized information packs.
Support of customer, regulatory and 3rd party audits.
Reporting and documenting customer requests via KPIs.
YOUR PROFILE
Education and Experience:
2 years previous experience working with regulatory documentation.
Knowledge of ISO9001, food safety or GxP systems.
University degree in life sciences
Knowledge of pharmaceutical industry requirements and regulations on APIs, Excipients and starting materials.
Previous experience with the FDA (or another national competent authority) and their requirements.
Team player, strong communication and interpersonal skills, with ability to work across all levels, and functions
OUR OFFER
We aim to create anenvironment where the best people want to work, where they can turn theirpassion into their job and realize their full potential.
Competitive pay andincentives.
Various healthcare planoptions as well as 401(k).
INTERESTED?
We look forward receiving your application.
Brenntag provides equalemployment opportunities to qualified applicants and employees without regardto race, color, religion, sex, sexual orientation, gender identity, nationalorigin, protected veteran status, disability or any other status protected byapplicable federal, state or local law.
Brenntag North America, Inc.and its subsidiaries useE-verify, a government-run, web-based system that allows employers to confirmthe eligibility of their employees to work in the United States.
For moreinformation, please go to https:
//www.e- or view the poster at https://e-If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability
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Brenntag is the leading global distributor of chemicals and ingredients, committed to connecting customers and suppliers within networks.
We add value for our customers and partners every step of the way:
through our product knowledge, innovation, and sustainable solutions, combined with our passion for service excellence and commitment to safety.
Headquartered in Essen, Germany and with more than 17,500 experts at about 600 locations in 72 countries, our two global divisions, Brenntag Essentials and Brenntag Specialties, offer a full range of industrial and specialty chemicals and ingredients.
Therefore, our clients and partners can count on us for global reach combined with local agility and execution.As an employer, we embrace diversity and foster a sense of community and collaboration in an environment where employees are encouraged to share ideas and work together.
We engage our employees in the company's mission for collective success, by building long-term stability and safety through trust and clarity across the organization.
We believe in empowering our employees to reach their full potential and shape the future.#J-18808-Ljbffr