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6 weeks 3 days ago
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Job Description
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The Opportunity:
Avantor, a Global Fortune 500 company is looking for a dedicated Regulatory Specialist to optimize our Avantor Fluid Handling (AFH) organization. This Radnor, PA role is full-time, hybrid.
If you have regulatory experience - let's talk!
Minimum Education:
* Bachelor's degree in science related field such as chemistry, biology, engineering
Required Experience (2+ Years)
* Collaboration Tools (i.e. Microsoft Office)
* Preparing/ directing the preparation of information or responses as requested by regulatory agencies.
* Product reviews and classifications.
* Identifying relevant regulations, guidance documents, international standards, or consensus standards and provide interpretive assistance.
* Applying for and maintaining Federal, State and local facility registrations, licenses, product listings, and reporting.
* Assisting sales team and customers with questions pertaining to regulatory requirements for the sale, transfer, and distribution of regulated products.
* Being responsible for the development & maintenance of related SOPs and best practices.
* Maintaining up-to-date knowledge of Federal, State, and local regulatory changes & recommending changes to company procedures in response
* Coordinating with departments to ensure the appropriate services are being provided in a timely and appropriate manner.
* Participating in related audits & inspections
* Supporting ongoing initiatives for continuous improvement.
* Preparing and presenting training material to Associates.
* Maintaining applicable master data for regulated products.
* Other duties as assigned.
Preferred Experience
* Medical device, pharmaceutical, other regulated industry
* Working knowledge of Federal, State, and local regulations such as Drug Enforcement Agency (DEA), Alcohol & Tobacco Tax & Trade Bureau (TTB), and Boards of Pharmacy (BOP)
* SAP
How you will thrive and create an impact:
As a Regulatory Specialist- Licensing, you will be responsible for collaboratively:
* Executing product compliance strategies, policies, and processes to ensure that Avantor's products meet regulatory standards and compliance certifications as well as Federal, State and local registration & licensing of regulated chemicals (i.e., DEA, TTB, BOP and other governing agencies) are obtained and maintained.
* Participating in product classification to identify and interpret applicable regulatory standards and requirements.
* Providing guidance and training to prevent compliance issues from the initial product onboarding throughout production and delivery of the final product.
* Utilizing business level verbal and written communication while deploying exemplary interpersonal, problem-solving, analytical, and quantitative skills
* Utilizing time management, planning, & organization skills while meeting deadlines and articulating complex processes and ideas
Why Avantor?
Dare to go further in your career. Join our global team of 14,500+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success.
At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world.
Apply today!
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
Why Avantor?
Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!
EEO Statement:
We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision.
3rd Party Non-Solicitation Policy:
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.
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