Job Summary
The Director of Regulatory Affairs for Biologics plays a vital role in overseeing the implementation of global regulatory strategies throughout the entire product lifecycle, beginning from early development stages to the commercialization phase. This position involves providing strategic leadership and managing interactions with health authorities to ensure compliance for the biologics portfolio of the company.
Responsibilities
- Lead the execution of global regulatory strategies for biologics.
- Oversee health authority interactions and communications.
- Ensure compliance with regulatory requirements for the company’s products.
- Support the product lifecycle from initial development through commercialization.
Qualifications
- A minimum of 10-12 years of extensive experience in regulatory affairs within the pharmaceutical or biotechnology industry, particularly focused on biologics.
- A bachelor’s degree in a scientific field is mandatory; an advanced degree is highly preferred.
