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Role Description

This position reports to the Functional Area Head, Global Regulatory Affairs and will be responsible for supporting the development and implementation of regulatory strategies, working closely with the cross functional teams to prepare, review and submit regulatory documents, manage documentation systems and maintain interactions with regulatory agencies.

• Work with multidisciplinary teams to ensure the quality, content, timelines, format of regulatory submissions and comply with all applicable regulations and guidelines governing the development, marketing and distribution of product candidates.
• Represent regulatory affairs at study teams; provide guidance and develop strategies to ensure timely submission and approval of study related documents including protocol, IB, DSUR, amendment, IMPD etc.
• Manage CROs depending on project assignment.
• Proactively reviews and interprets regulatory guidelines with respect to impact on development programs.
• Support agency interactions, including appropriate documentation of interaction, decisions and outcomes; contribute to the development of meeting requests, briefing documents and other supporting material.
• Archive management for related projects including submission archive and tracking submission/approval dates and Health Authorities correspondences.
• Work collaboratively with Stakeholders and peers to align on priorities and support corporate and department strategic goals.

Qualifications

• Bachelor of Science Degree in a relevant area is required. Advanced science degree is preferred.
• RAC certification or other equivalent is preferred.

Requirements

• Minimum Bachelor’s degree in a scientific or related discipline, 5+ years of pharmaceutical industrial experience, at least 2 years of regulatory submission experience for product(s) development in the US and/or EU.
• Experience supporting clinical development teams in the metabolic disease space is preferred.
• Experience from IND through to BLA (or NDA), across all disciplines (nonclinical, clinical, CMC), as well as supporting regulatory interactions.
• Experience working in multi-culture/multi-countries environment is preferred.

Skills

• Knowledge and understanding of metabolic disease biology and translational research is required.
• Knowledge of US and EU regulations for biosimilars and/or innovative medicines.
• Excellent written and verbal communication skills.
• Ability to work cross-functionally in a fast-paced and collaborative environment.
• Strong attention to detail and problem-solving skills.
• Proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).