Senior, Regulatory Specialist

The Opportunity:

Avantor, a Global Fortune 500 company is looking for a dedicated Senior Regulatory Specialist to optimize our Biopharma/ Regulatory Affairs organization. This role is USA remote.

If you have regulatory experience – let’s talk!

Minimum Education Requirement:

• Bachelor’s Degree: Biology, Chemistry, Biochemistry, Biomedical Engineering, Legal Studies, Public Health Administration, Medical/Scientific Writing, or related
•  MS in Regulatory Sciences is preferred.

Required Experience (2+ yrs):

• Working in regulated industry (pharmaceutical, or related).
• Maintaining current knowledge base of existing and emerging global regulations, standards, and guidance documents.
• Regulatory Affairs and/or Quality processes, both pre- and post-market.
• Reviewing and evaluating changes to determine quality/regulatory impact.
• Experience with eCTD format
• Developing responses to regulatory deficiencies and/or findings.
• Working knowledge of 21 CFR 210/211, ICH Q7, and/or IPEC.

Preferred Experience:

• Knowledge of ICH Q7 and IPEC regulations to develop regulatory strategies.
• Familiarity with compilation, maintenance, and submission of drug substance regulatory dossiers including Drug Master Files and product registrations globally. Experience with US Drug Master File, Canadian Master File, China Registration, is a plus.
• Demonstrated understanding of GDUFA and CARES requirements.
• Collaborating cross departmentally to respond to regulatory agency information requests.
• Ability to develop teams, create project plans, and establish timelines for growth opportunity projects and maintenance activities.
• Maintaining federal and state licenses for facilities and products.
• Compile data for reporting to regulatory agencies. Specific experience with
• Evaluating complex issues, creating recommendations, performing risk assessments, and providing reporting to summarize processes.
• Collaborating with R&T to provide regulatory guidance for innovation projects.
• Ability to recommend changes to company procedures in response to changes in regulations and/or company strategy.
• Experience preparing responses to customer requests for information such as: product data, written regulatory affairs statements, and/or questionnaires.
• In-depth, hands-on experience with GMP manufacturing, compendial compliance, validations, impurities analysis, stability, and/or general auditing experience.
• RAC Certification

How you will thrive and create an impact:

The position is part of the Avantor Regulatory Affairs organization. With attention to detail the successful candidate will bring:

• Business level verbal and written communication skills
• Exemplary interpersonal skills, which are required to communicate with customers, suppliers, and team members.
• Organization and planning skills.

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!

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+