The Director of Regulatory Affairs Strategy will take a lead role in crafting and executing global and regional regulatory strategies for a range of projects and products. The incumbent will collaborate with various internal teams, maintain vital relations with health authorities, and play an integral role in influencing the regulatory landscape. This is a pivotal role for a professional with a robust regulatory background, seeking to make significant contributions to our organizational goals.
Key Responsibilities:
Formulate and implement global and regional regulatory strategies for complex projects/products, optimizing delivery time and success probability.
Collaborate with diverse internal teams to ensure timely and quality regulatory contributions.
Develop and sustain relationships with Health Authority contacts.
Align regulatory strategies with business needs and monitor the progress of regulatory plans, communicating any variances and risks to Senior Management.
Create tailored submission packages and work closely with other Regulatory Strategists to maintain consistency and high-quality standards across processes and systems.
Influence the regulatory environment through engagements with Health Authorities and trade associations, ensuring business compliance and adherence to regulatory standards.
Requirements
Bachelor's Degree in Science is required; an advanced scientific degree or business qualification is an advantage but not essential.
Minimum of 8 years of regulatory experience, with 5 years of Global experience preferred.
Comprehensive knowledge of the regulatory environment and a proven ability to impact regulatory strategy development.
Experience managing diverse regulatory activities across different stages of product lifecycle.
Ability to deliver projects on time, within budget, and to quality standards.
Successful partnership with various internal lines and proven negotiation skills with major Health Authorities.
Knowledge of assigned therapeutic areas/disease areas preferred.
