Regulatory Affairs Scientist I
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
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
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.”
#LI-TCW #LI-onsite #LI-hybrid
As published by workable · 5 questions · 1 written answer
Basics
First name, Last name, Email, Headline, Full Legal Name, Preferred Name, Preferred Pronouns, Phone, Address, Photo, Summary, Resume, Cover letter, Are you authorized to work lawfully in the country this job was posted in?, Will you now or in the future require sponsorship for employment in the country where this job is located?, When would you be available to join Allucent?, How long is your notice period?, Expected Minimum Base Salary OR Expected Base Salary Range, Salary Currency, Gross or net income?, What type of employment are you looking for? (Please select all that apply), Preferred Workplace Type
Short answers (1)
- How many years of experience do you have with regulatory requirements of US FDA, Health Canada and / or European authorities as a regulatory affairs scientist or equivalent title?
Pick from a list (3)
- This role is based in our Cary, NC office. Are you able to work at least 2 days in-office weekly?
- What is your highest degree in a scientific field?
- Which of the following countries/regions do you have regulatory requirement knowledge of drug, biologic, or device development?
Written answers (1)
- If you do not have regulatory affairs experience, describe a few of your transferrable skills that you believe would make you a good fit for this position.