Regulatory Affairs Scientist

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

Bring your expertise in regulatory affairs and join Allucent as a Regulatory Affairs Scientist I or II to assist clients with regulatory affairs related activities for drug, biologic, or medical device products and serve on project teams in various capacities such as Subject matter Expert, Assistant Consulting Lead, and Consulting Lead.

• →Prepare and review regulatory and scientific documents for drugs, biologics, or devices, ensuring accuracy, quality, and compliance across development and lifecycle stages.
• →Support regulatory strategy and Health Authority (HA) interactions, including briefing materials, meeting preparation, responses to inquiries, and reporting requirements.
• →Translate regulatory guidance and submission requirements into practical plans, including eCTD submissions, change impact assessments, and post-approval regulatory activities.
• →Collaborate with clients and cross-functional teams while building regulatory expertise, staying current on evolving regulations, and mentoring junior team members.

• Based near Cary, NC and able to come into the office 2-3 times per week.

• B.Sc., M.Sc., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development  

• Regulatory knowledge of drug, biologic, or device development focusing on regulatory requirements for US, EU, and / or Canada  

Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.

If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.

Together we SHINE. Find more information about our values.

*Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

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