Senior Epidemiologist

Position Overview:

The Regulatory Epidemiology Director will lead and oversee the epidemiological aspects of regulatory activities, ensuring compliance with national and international regulations. This role involves directing research and analysis to support regulatory submissions, guiding policy development, and collaborating with cross-functional teams to address public health issues.

Key Responsibilities:

• Leadership and Strategy:
• Develop and implement strategies for regulatory epidemiology projects.
• Provide expert guidance on epidemiological methods and regulatory requirements.
• Lead and mentor a team of epidemiologists and data analysts.
• Regulatory Submissions and Compliance:
• Oversee the design and execution of epidemiological studies to support regulatory submissions.
• Ensure all epidemiological data and analyses comply with regulatory standards (FDA, EMA, etc.).
• Review and approve epidemiological sections of regulatory documents.
• Research and Analysis:
• Direct the development and application of epidemiological models and statistical analyses.
• Interpret and present complex data to regulatory agencies, stakeholders, and decision-makers.
• Collaborate with internal and external researchers to advance epidemiological research.
• Policy Development and Advocacy:
• Contribute to the development of public health policies and regulations.
• Represent the organization in regulatory meetings, workshops, and conferences.
• Advocate for evidence-based regulatory decisions that enhance public health.
• Collaboration and Communication:
• Work closely with clinical, medical, and regulatory affairs teams to align strategies.
• Build and maintain relationships with regulatory bodies, industry groups, and academic institutions.
• Communicate findings and recommendations to senior leadership and external partners.

Qualifications:

• Education:
• PhD or equivalent in Epidemiology, Public Health, or a related field.
• Experience:
• Minimum of 10 years of experience in epidemiology, with at least 5 years in a regulatory environment.
• Proven track record of leading epidemiological studies for regulatory purposes.
• Experience with regulatory submissions and compliance in the pharmaceutical or medical device industries.
• Skills:
• Strong leadership and team management abilities.
• Expertise in epidemiological methods, study design, and statistical analysis.
• Excellent communication and presentation skills.
• Ability to work collaboratively in a multidisciplinary environment.
• In-depth knowledge of regulatory guidelines and standards (FDA, EMA, etc.).
• Other:
• Demonstrated ability to influence policy and advocate for public health initiatives.
• Strong analytical and problem-solving skills.
• Ability to travel as required.