Senior Manager Regulatory Affairs

· Senior Regulatory Affairs manager will be involved developing global regulatory strategies and execution to support the development program(s) across early- and late-stage development.

· Managing regulatory preparations, review, and submissions of regulatory packages in terms of content and timelines.

· Participate in interactions with health authorities (Pre-IND, IND, Scientific Advice etc) and ensure input implementation in the development program.

· Provide regulatory input across preclinical, clinical, CMC ensuring compliance with applicable regulations

· Support product development program(s) from the regulatory perspective

· Serve as a regulatory subject-matter expert to cross-functional teams.

Experience:

· 5 year experience in regulatory interactions with FDA and EMA including country specific meetings

· Experience in late stage product development programs

· Experience in Rare disease programs- advantage

· Experience in regulatory development with small molecules- advantage

· Understanding of clinical, preclinical, CMC requirement for various state of drug development

· Experience in clinical development in Rare disease

Skills:

· Strong scientific/technical background. Msc/PhD in biology / Biochemistry

· Excellent written communication, strategic thinking, and problem-solving orientation