Regulatory Affairs Scientist I

NCBioImpact; Cary (NC); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Flexible Working hours

Remote/hybrid options depending on the

Job summary

Allucent is seeking a Regulatory Affairs Scientist I to support regulatory activities for drugs, biologics, or devices and contribute to project teams in roles such as Subject matter Expert or Consulting Lead. The candidate should be based near Cary, NC, with the ability to come into the office 2–3 times per week. Ideal applicants hold a B.Sc.

or M.Sc. in a scientific field and possess regulatory knowledge across US, EU, and/or Canada regulatory requirements.

Qualifications

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

Responsibilities

• 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.

Education

B.Sc., M.Sc., or equivalent degree

Job description

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.

About the Role

Bring your expertise in regulatory affairs and join Allucent as a Regulatory Affairs Scientist I 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.

Your main responsibilities will include but not limited to:

• 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.

About you

• 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

About Allucent

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.

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*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.”