Director, Regulatory Affairs

About the role

Allucent is looking for a Director of Regulatory Affairs to guide clients through the complexities of drug, biologic and medical device development. The Director leads and mentors regulatory teams, shapes strategies and ensures high-quality, scientifically sound submissions, acting as a subject matter expert, technical lead or consulting lead across project teams. The role reviews and authors regulatory and scientific documents and serves as a trusted expert in Health Authority interactions.

Key responsibilities

• Guide clients through regulatory requirements for drug, biologic and device development
• Review and prepare Health Authority meeting requests and briefing documents
• Oversee and manage regulatory projects of varying complexity
• Provide strategic advice on turning regulatory requirements into practical plans and solutions
• Review and author regulatory and scientific documents

Required profile

• B.Sc., M.Sc., Ph.D. or equivalent degree in a scientific area, with equivalent relevant experience in drug, biologic or device development
• 8 years' experience with regulatory requirements of the US FDA, Health Canada and/or European authorities
• Advanced regulatory knowledge of drug, biologic or device development, covering US, EU and/or Canadian requirements
• Strategic leadership, ability to solve complex regulatory challenges and drive tangible impact on global healthcare

Required skills

• Knowledge of Health Authority regulatory guidance and regulations for regulatory filings
• Advanced knowledge of the CTD format and structure for regulatory submissions

What we offer

• Comprehensive benefits package and competitive salaries per location
• Departmental study and training budget
• Flexible working hours and the option of remote or hybrid work depending on location
• Leadership, mentoring and internal growth opportunities
• Buddy program, internal training platforms, referral and loyalty award programs