Senior Director Regulatory Strategy & Labelling Lead

ROLE OVERVIEW

We are currently looking for a Senior Director of Regulatory Strategy and Labelling Lead to join a leading global pharmaceutical company supporting global healthcare innovations. This exciting opportunity offers the chance to shape and drive our client’s regulatory strategies across a diverse portfolio of assets, ensuring compliance, optimal labelling, and robust interactions with regulatory authorities worldwide.

You will play a pivotal role in leading strategic initiatives and guiding senior leadership decisions to achieve superior regulatory outcomes.

This role is ideal for a strategic thinker with extensive experience in regulatory affairs and experience in leadership.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Senior Director of Regulatory Strategy and Labelling Lead will be varied however the key duties and responsibilities are as follows:

• Provide overall regulatory strategic leadership for all products, including the development and deployment of expertise to meet portfolio regulatory deliverables and lifecycle management goals.
• Lead the creation and execution of global regulatory strategies for the portfolio, ensuring alignment with corporate objectives, CMC considerations, and market needs.
• Proactively engage with internal stakeholders and senior leadership to develop regulatory strategies that support commercial and development goals, including external engagement with health authorities and expert consultants.
• Ensure regulatory strategies encompass risk mitigation plans, clearly communicating these risks and mitigations internally to guide decision-making.
• As the Senior Director, you will oversee interactions with global regulatory authorities, ensuring clear understanding of feedback and requirements, and effectively integrating these into strategic plans.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Senior Director of Regulatory Strategy and Labelling Lead we are looking to identify the following on your profile and past history:

• A Degree or higher level in a relevant field (e.g., Pharmaceutical Chemistry / Quality Assurance / Quality Management for QA roles).
• Proven track record of more than 10 years in Regulatory Affairs strategy, with experience in developing and implementing innovative regulatory plans across diverse product portfolios.
• Extensive experience engaging with global regulatory agencies such as EMA, FDA, BfArM, MHRA, TGA, and PMDA.
• Demonstrated ability to lead collaborative initiatives, influence senior stakeholders and develop and manage teams.

WHAT’S IN IT FOR YOU?

Joining our client means stepping into a leadership role where your expertise will directly impact global health, working within a committed and inclusive environment. You will have the opportunity to shape regulatory strategies for pioneering products, develop your leadership skills, and influence best practices within the industry. Competitive benefits, ongoing professional development, and a collaborative culture await the successful candidate.

Key Words: Regulatory Affairs / Regulatory Strategy / Labelling / Global Regulatory / Pharmaceutical / Leadership / Stakeholder Engagement / Compliance / Lifecycle Management / Health Authorities /CMC

"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."