Director, Regulatory Affairs
Role Overview
As a Director of Regulatory Affairs, you will guide clients through the complexities of drug, biologic, and medical device development.
You will lead and mentor regulatory teams, shape strategies, and ensure the delivery of high-quality, scientifically sound submissions.
You will serve as a trusted expert in Health Authority (HA) interactions and translate regulatory requirements into clear, actionable plans.
In this role, you will act as a Subject Matter Expert, Technical Lead, or Consulting Lead across diverse project teams.
You will also review and author regulatory and scientific documents while driving successful outcomes for clients.
Most importantly, you will make a direct impact on advancing innovative therapies and global healthcare.
Your main responsibilities will include but not limited to:
• Has advanced knowledge of HA Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management
• Reviews and prepares HA meeting requests and briefing documents.
• Oversees and manages regulatory projects of varying complexities.
• Provides strategic advice and expertise in translating regulatory requirements into practical plans and solutions.
• Has advanced knowledge of CTD format and structure for regulatory submissions.
Full Job Posting
Your main responsibilities will include but not limited to
- Has advanced knowledge of HA Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management
- Reviews and prepares HA meeting requests and briefing documents.
- Oversees and manages regulatory projects of varying complexities.
- Provides strategic advice and expertise in translating regulatory requirements into practical plans and solutions.
- Has advanced knowledge of CTD format and structure for regulatory submissions.
About You
If you are a strategic leader with deep regulatory expertise across both pre-and-post marketing stages of development and thrive on leading regulatory projects, solving complex regulatory challenges, and making a tangible impact on global healthcare, you’ll thrive here.
To be successful we are looking for the following traits and behaviors:
Requires a B.Sc., M.Sc., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
8 years’ experience with regulatory requirements of US FDA, Health Canada and / or European authorities
Advanced 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
Apply now!
If you are interested in this role please apply through the button or for more information reach out to Demetria Eggleston at [email protected]
Disclaimers
*Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within a 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-DE1
#LI-Remote
About Allucent
The Full-Service CRO Partner for Biopharma Clinical Development
Visit company websiteJobs and hiring trendsApply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Allucent
Project Manager II (Oncology)
, USA
Local Contact Person for Pharmacovigilance (LCPPV) - Freelance
, AUS
Clinical Project Manager (Australia)
, AUS
Directeur Pharmacométricien (Director Pharmacometrician)
Montréal, CAN
Director, Pharmacometrics
, USA
Sr. Director, Business Development
, USA
Project Manager II, Global Project Leadership
, USA
Account Development Manager
, USA