**Director, Global Regulatory Affairs - West Coast**
A high-level position is now open for an exceptional Director of Global Regulatory Affairs based on the West Coast. This role offers the opportunity to spearhead regulatory strategies, navigate product development complexities and ensure compliance across international markets.
As the guiding force behind our company's regulatory approach, your influence will be key to shaping market access and maintaining rigorous adherence to worldwide regulations. You'll join a dynamic team committed not only to innovation, but also exemplary standards that keep us at the forefront of our industry.
**Role Responsibilities:**
- Develop and implement cutting-edge Global regulatory strategies for clinical studies, marketing approvals, development plans and risk assessment, acting as the lead for the global regulatory program.
- Prepare comprehensive submissions for Health Authority review.
- Lead successful meetings with various global Health Authorities.
- Manage regional teams towards cohesive global compliance efforts.
- Provide High level oversight, direction, and mentorship to the team for general regulatory strategies and projects.
- Reporting to CEO, CSO
- Lead the submissions process
**Skills Required:**
*Regulatory Expertise*: 15+ years in the pharmaceutical industry, with deep understanding of pharmaceutical regulations necessary for steering products through complex approval processes globally. This candidate must have experience with gaining approval for new drug applications and biologic applications, as well as marketing authorizations, utilizing in house teams for the development of these products/submissions.
*Strategic Guidance*: Ability provide long-term vision aligning with business objectives, and experience in managing early to late stage products, as well as post approval phases. This role will be leading the development of the company's global regulatory strategy
*Leadership Abilities*: Superior managerial skill set fostering collaborative environment goal-oriented outcomes
*Health Authority Interaction*: Must have experience leading FDA and/or EMA interactions/meetings
This is an exciting opportunity to join a growing team that will make a difference in under-served patient's lives. If you have interest, please apply below.
