Allucent is hiring an Associate Director, Regulatory Affairs

At Allucent, our mission is to help bring new therapies to light. We are seeking an Associate Director, Regulatory Affairs to serve as a trusted expert for our clients. In this role, you will guide clients through the complexities of drug, biologic, and medical device development, translate regulatory requirements into clear plans, and lead teams to deliver high-quality submissions.

What You'll Do

• Guide clients through the complexities of drug, biologic, and medical device development.
• Lead and mentor regulatory teams, shaping regulatory strategies.
• Ensure the delivery of high-quality, scientifically sound submissions.
• Serve as a trusted expert in Health Authority (HA) interactions.
• Translate regulatory requirements into clear, actionable plans.
• Act as a Subject Matter Expert, Technical Lead, or Consulting Lead across diverse project teams.
• Review and author regulatory and scientific documents to drive successful client outcomes.
• Review and prepare HA meeting requests and briefing documents.
• Provide specialized CMC regulatory expertise across both pre-and post-marketing strategies.
• Provide strategic advice and expertise in translating regulatory requirements into practical plans.
• Evaluate change impact and necessary HA reporting requirements and strategies for products from development through post-approval management.

What We're Looking For

• B.Sc., M.Sc., Ph.D., or equivalent degree in a scientific area, or an 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.
• Advanced knowledge of HA Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management.
• Advanced knowledge of CTD format and structure for regulatory submissions.

Benefits & Compensation

• Comprehensive benefits package and 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.
• Eligibility for our Loyalty Award Program.

Work Mode

This position offers a hybrid work model.

Allucent is an equal opportunity employer.