Senior Regulatory Specialist

What we're looking for

• Education: Bachelor's Degree: Biology, Chemistry, Biochemistry, Biomedical Engineering, Legal Studies, Public Health Administration, Medical/Scientific Writing, or related is required.

• Experience: A minimum of 2 years of experience working in a regulated industry (pharmaceutical, or related) is required.

• Working knowledge of ICH Q7, IPEC, CARES, GDUFA is required.

• Demonstrated understanding of Regulatory Affairs processes, both pre- and post-marketing is required.

• Excellent verbal and written communication. Strong interpersonal skills are required to talk to customers, suppliers, and fellow associates.

• Preferred Qualifications:

  • RAC or MS in Regulatory Sciences is desired.

  • Experience with US Drug Master File, Canadian Master File, China Registration, and other international regions is desired.

  • Attention to detail, strong organization, and planning skills desired.

  • Project Management experience is desired.

How you will thrive and create an impact

• Compilation, maintenance, and submission of regulatory dossiers including Drug Master Files and product registrations globally.

• Ability to develop teams, create project plans, and establish timelines for growth opportunity projects and maintenance activities.

• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

• Participation in change control and risk management multi-disciplinary teams.

• Development of knowledge of and changes to global regulatory requirements and standards for the pharmaceutical industry.

• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.

• Determine the types of regulatory submissions or internal documentation that are required to support proposed changes.

• Collaborate with R&T and provide regulatory guidance for innovation projects.

• Apply for and maintain facility registrations, drug listings, federal and state licenses.

• Complete regulatory reporting to regulatory agencies.

• Recommend changes to company procedures in response to changes in regulations and/or company strategy.

• Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, or questionnaires.

• Ability to evaluate complex issues, create recommendations, and provide reporting to summarize the process.

• Experience in executing knowledge of ICH Q7 and IPEC regulations to develop regulatory strategies.

• Work cross-functionally with other groups to meet deliverables.

• Other duties as assigned.

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!

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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.

EEO Statement:

We are an Equal Employment/Affirmative Action employer. 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 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 , , and .

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.