Job Description

Step into a leadership role where your expertise drives innovation. As an

Associate Director, Regulatory Affairs

, you'll guide clients through the complexities of drug, biologic, and medical device development--leading teams, shaping strategies, and ensuring successful submissions. This is your chance to be the trusted expert who turns regulations into real-world impact on global healthcare.

About the Role

As an Associate 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. Provide specialized CMC regulatory expertise across both pre-and post- marketing strategies. Provides strategic advice and expertise in translating regulatory requirements into practical plans and solutions. Evaluates change impact and necessary HA reporting requirements and strategies for drug products or devices from development through post-approval management. Has advanced knowledge of CTD format and structure for regulatory submissions.

Requirements

About You

If you are a strategic leader with deep knowledge of CMC regulatory expertise across both pre-and-post marketing strategies and thrive on guiding teams, 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 6 years' experience with regulatory requirements of US FDA, Health Canada and / or European authorities Experience with CMC regulatory pre and post marketing 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

Apply now!

If you are interested in this role please apply through the button or for more information reach out to Demetria Eggleston at Demetria.eggleston@allucent.com

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."