About the Role:
We are seeking a highly experienced Associate Director in Global Regulatory Strategy to join a leading pharmaceutical organization. This role offers the opportunity to drive regulatory strategy for neurology products across development and post-approval stages. You will act as a key point of contact for global and regional regulatory authorities, lead submissions (CTA/MAA), and contribute to lifecycle management strategies.
This is a senior, strategic position with significant exposure to cross-functional teams, senior stakeholders, and international regulatory initiatives. The successful candidate will have the freedom to shape regulatory strategy, influence business decisions, and represent the organization at regulatory and industry events.
Key Responsibilities:
* Lead and execute global regulatory strategies for assigned products across neurology therapeutic areas.
* Manage regulatory submissions (CTAs, MAAs) and liaise directly with authorities.
* Provide strategic guidance to cross-functional teams and influence decision-making.
* Oversee product lifecycle management, ensuring compliance with international regulations.
* Mentor and develop junior regulatory staff and contribute to team growth.
Requirements:
* Significant experience in global regulatory affairs with proven submission experience (CTA/MAA).
* Experience interacting with regulatory authorities, ideally EMA, MHRA, or comparable agencies.
* Strong understanding of lifecycle management for both development and established products.
* Excellent communication and stakeholder management skills.
* Scientific or pharmaceutical background (PhD, PharmD, or MSc in a relevant field preferred).
* Experience in neurology is desirable but not essential.
Why Join:
This is a unique opportunity to work in a collaborative, forward-thinking environment, with exposure to senior leadership and international regulatory operations. You will play a pivotal role in shaping the regulatory strategy and supporting products that make a meaningful impact on patients.