Regulatory Affairs Scientist I

Xtalks; Cary (NC); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

Flexible hours

Remote/hybrid depending on location

Training budget

Job summary

Allucent is seeking a Regulatory Affairs Scientist I to support regulatory activities for drug, biologic, or device programs and contribute to project teams across roles such as Subject matter Expert and Consulting Lead.

You will prepare regulatory documents, assist with HA interactions, and translate guidance into practical plans, including eCTD submissions, while mentoring junior members and staying current with evolving regulations. Hybrid work options available.

Qualifications

• Regulatory knowledge for US FDA, Health Canada, or European authorities.
• B.Sc., M.Sc., or equivalent degree in a scientific field.
• 1+ years of Regulatory experience or similar exposure.

Responsibilities

• Prepare and review regulatory and scientific documents for drugs, biologics, or devices, ensuring accuracy, quality, and compliance.
• Support regulatory strategy and Health Authority interactions, including briefing materials and meeting prep.
• Translate regulatory guidance into practical plans, including eCTD submissions and post-approval activities.
• Collaborate with clients and cross-functional teams and mentor junior team members.

Skills

Regulatory knowledge

Mentoring

Education

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

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.

Requirements

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
• >1 years' experience with regulatory requirements of US FDA, Health Canada and / or European authorities.

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.