Manager/Sr. Manager - Regulatory Affairs (Pharmaceuticals)

TL;DR

Manager/Sr. Manager - Regulatory Affairs (Pharmaceuticals): Supporting the development and implementation of regulatory strategies for pharmaceutical products with an accent on regulatory submissions and interactions with health agencies. Focus on managing the submission lifecycle from IND to BLA/NDA and ensuring adherence to US and EU guidelines.

Company

hirify.global is a pharmaceutical company dedicated to the development of innovative medicines and biosimilars.

What you will do

• Develop and implement regulatory strategies in collaboration with multidisciplinary cross-functional teams.
• Prepare, review, and submit regulatory documents, including protocols, IB, DSUR, and IMPD.
• Manage CROs and maintain professional interactions with regulatory agencies.
• Interpret regulatory guidelines to evaluate their impact on development programs.
• Manage submission archives and track approval dates and Health Authority correspondences.
• Align with stakeholders and peers to support corporate and department strategic goals.

Requirements

• Bachelor of Science degree in a relevant scientific area.
• Minimum 5+ years of pharmaceutical industrial experience.
• At least 2 years of experience with regulatory submissions for product development in the US and/or EU.
• Experience across nonclinical, clinical, and CMC disciplines from IND through to BLA or NDA.
• Strong knowledge of US and EU regulations for biosimilars and innovative medicines.
• Knowledge and understanding of metabolic disease biology and translational research.

Nice to have

• Advanced science degree.
• RAC certification or equivalent.
• Experience supporting clinical development teams specifically in the metabolic disease space.
• Experience working in multi-cultural or multi-country environments.