About the Company
Our client is an innovative biotechnology company focused on advancing RNA medicines to treat both rare and prevalent diseases. With a strong pipeline, they aim to revolutionize healthcare through cutting-edge therapies, including for neuromuscular and genetic disorders.
Position Overview
We are seeking a Senior Director of Regulatory Affairs to lead global regulatory strategy for key programs. This role will involve collaborating with cross-functional teams, ensuring regulatory compliance, and managing submission processes to meet corporate goals.
Key Responsibilities
- Lead the preparation and submission of regulatory documents, ensuring compliance with industry standards.
- Provide strategic guidance on regulatory submissions (IND, CTA, NDA, MAA) and agency interactions.
- Oversee regulatory submission packages and explore opportunities for expedited pathways (e.g., Breakthrough Therapy Designation).
- Communicate regulatory status, risks, and mitigation plans with internal teams and external stakeholders.
- Contribute to departmental process improvements and stay updated on regulatory changes.
Qualifications
- BA/BS in life sciences; MSc/PhD a plus.
- 12+ years in the pharmaceutical industry, with 6+ years in regulatory affairs.
- Experience in regulatory strategy, writing, and IND/CTA submissions.
- Proven ability to lead regulatory initiatives and communicate strategies effectively.
Key Skills
- Strong knowledge of ICH, FDA, and EMA guidelines.
- Experience with global regulatory authorities (FDA, EMA, Health Canada).
- Expertise in regulatory writing, eCTD, and submission management.
- Strong leadership, project management, and strategic thinking skills.