Contract: Permanent Full-Time
Closing Date: 12/09/25
We are seeking experienced and strategic Regulatory Affairs Strategists to drive global regulatory strategy and execution for innovative, development-stage, and marketed therapies.
There are opportunities to work on both a Global and Regional scale for one or more products, providing cross-functional guidance and leadership throughout the product lifecycle. Experience in Therapeutic expertise in Oncology, Immunology, or Inflammatory Diseases is required for this role.

WHAT QUALIFICATIONS AND EXPERIENCE DO I NEED TO APPLY?

• Advanced degree in life sciences or related field (PharmD, PhD, MD, MS, or MBA preferred).
• Minimum of 8 years’ experience in regulatory affairs or related roles in the biopharma industry.
• Proven success in developing and executing global regulatory strategies.
• Therapeutic expertise in Oncology, Immunology, or Inflammatory Diseases strongly preferred.
• In-depth knowledge of FDA, EMA, ICH, and international regulatory frameworks.
• Experience supporting both development-stage and marketed products.
• Strong history of preparing major regulatory submissions and leading health authority interactions.
• Effective leadership in cross-functional, matrixed environments.

WHAT WILL I BE DOING IN THIS ROLE?

• Leading global regulatory strategy and execution for assigned development-stage and/or marketed products.
• Serving as Global or Regional Regulatory Lead, offering strategic insights across therapeutic areas such as Oncology, Immunology, or Inflammatory Diseases.
• Chairing Regulatory team meetings and aligning stakeholders across global regulatory functions.
• Leading or supporting key regulatory submissions, including INDs, CTAs, NDAs, BLAs, MAAs, and related amendments and renewals.
• Representing Regulatory Affairs on global development teams, cross-functional committees, and governance bodies.
• Planning, preparing, and participating in health authority interactions, including drafting briefing documents and response packages.
• Monitoring and interpreting evolving global regulatory guidelines and integrating regulatory intelligence into strategy and execution.
• Ensuring continued regulatory compliance across regions, including timely submissions for labelling, safety, and post-marketing requirements.
• Overseeing lifecycle management, including variations, renewals, and annual reports.
• Supporting global labelling development and updates in alignment with clinical and regulatory expectations.
• Providing mentorship to team members and contributing to continuous process improvement within Regulatory Affairs.

WHAT WILL MAKE ME EXCEL IN THIS ROLE?

• Strategic, analytical mindset with a deep understanding of the drug development lifecycle.
• Excellent communication, negotiation, and interpersonal skills.
• Ability to lead and influence teams without direct authority.
• High attention to detail, with a strong commitment to documentation quality and compliance.
• Comfortable operating in dynamic, fast-paced environments and managing ambiguity.