Director of Regulatory Affairs (Pharmaceuticals, Remote)

Job summary

This role involves providing expert scientific and regulatory guidance for an early phase drug reformulation project in the ophthalmology sector. The consultant will interpret preclinical data and define the regulatory and clinical development strategy in Europe.

Qualifications

• Bachelor’s degree in life sciences or equivalent; advanced degree preferred.
• Extensive experience in regulatory affairs, particularly in early phase strategy.
• Strong background in ophthalmology drug development.
• Proven ability to interpret preclinical data and connect it to clinical and regulatory strategies.
• Experience with European regulatory authorities and scientific advice procedures.

Responsibilities

• Provide scientific interpretation of preclinical ophthalmology data, including in vivo models for proof of concept assessment.
• Translate nonclinical findings into regulatory and early clinical development recommendations.
• Define and guide the overall regulatory and clinical strategy for the program.
• Advise on optimal next steps in development, including study design and development pathways.
• Support planning and execution of interactions with European regulatory authorities, including scientific advice.
• Recommend appropriate regulatory pathways and authority engagement strategies within Europe.

Skills

• Strong analytical and strategic thinking skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and manage multiple priorities effectively.

Education

• Bachelor’s degree in life sciences or equivalent; advanced degree preferred.

Tools

• Familiarity with regulatory submission tools and platforms relevant to the pharmaceutical industry.